BEUDAMED
    190 results · 16ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.

    FDA Enforcement
    Class II ·Terminated·Bradshaw Medical Inc.·May 18, 2016

    ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025

    Temporary Titanium Abutments

    FDA Enforcement
    Class II ·Ongoing·DDS Lab·February 12, 2025

    IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

    FDA Enforcement
    Class II ·Ongoing·LTS Therapy Systems, LLC·August 6, 2025

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Enforcement
    Class II ·Terminated·LDR Spine USA, Inc.·October 12, 2016

    IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

    FDA Enforcement
    Class II ·Ongoing·LTS Therapy Systems, LLC·August 6, 2025

    Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TOTAL KNEE CDS-LF n. TOTAL SHOULDER CDS-LF o. TOTAL KNEE CDS-3 p. TOTAL HIP CDS-3 q. LOWER EXTREMITY CDS-LF r. TOTAL HIP-LF s. TOTAL HIP/KNEE CDS t. SPINE PROCEDURE u. OPEN HEART v. LAMI w. UPPER EXTREMITY CDS x. LOWER EXTREMITY CDS y. KNEE ARTHROSCOPY CDS z. KNEE ARTHROSCOPY CDS-LF aa. SHOULDER CDS-LF bb. PODIATRY CDS cc. KNEE ARTHROSCOPY CDS dd. SHOULDER ARTHROSCOPY CDS ee. ACL CDS ff. CRANIOTOMY CDS gg. TOTAL KNEE CDS hh. TOTAL KNEE ii. TOTAL HIP CDS jj. NEW LONDON TOTAL KNEE CDS kk. TRAUMA CDS-LF ll. TOTAL JOINT CDS mm. CRANIOTOMY CDS-1 nn. SHOULDER CDS-1 oo. SPINE CDS-1 pp. TOTAL KNEE CDS-1 qq. TOTAL HIP CDS-1 rr. LOWER EXTREMITY CDS-2 ss. HAND CDS-2 tt. KNEE ARTHROSCOPY CDS-2 uu. HAND CDS vv. BACK CDS ww. FRACTURE TABLE CDS xx. ORTHO OP CDS yy. ARTHROSCOPY CDS zz. ORTHO MINOR CDS aaa. TOTAL JOINT KNEE CDS bbb. TOTAL JOINT HIP CDS ccc. SHOULDER CDS-LF ddd. ZALE CRANIOTOMY CDS eee. ZALE TOTAL KNEE CDS fff. ZALE EXTREMITY CDS ggg. OPEN SHOULDER CDS hhh. LOWER EXTREMITY CDS iii. FHT TOTAL HIP jjj. FHT TOTAL KNEE RPLCMNT kkk. TOTAL HIP CDS lll. TOTAL KNEE CDS mmm. CCOC ACL-LF nnn. CCOC SPINAL FUSION ooo. CCOC MAJOR EXTREMITY ppp. EXTREMITY CDS qqq. PODIATRY CDS rrr. SHOULDER CDS sss. DISTAL LEG CDS ttt. HIP NAILING CDS uuu. SHOULDER CDS vvv. TOTAL HIP CDS www. UPPER EXTREMITY CDS xxx. BASIC ORTHO CDS yyy. TOTAL HIP PROCEDURE zzz. TOTAL JOINT CDS-LF aaaa. SHOULDER CDS-LF bbbb. HAND CDS-LF cccc. KNEE ARTHROSCOPY CDS-LF dddd. TOTAL JOINT eeee. UPPER EXTREMITY CDS ffff. LOWER EXTREMITY CDS gggg. GENERAL ORTHO CDS hhhh. ARTHROSCOPY CDS iiii. KNEE ARTHROSCOPY CDS jjjj. SHOULDER ARTHROSCOPY CDS kkkk. KNEE ARTHROSCOPY CDS llll. TOTAL ORTHO CDS mmmm. GROTH LOWER EXTREMITY CDS nnnn. HIP TOTAL PACK-ANTERIOR oooo. PRAIRIE STAR SPINE CDS pppp. 4TH FLOOR SHOULDER ARTHROSCOPY qqqq. FOOT & ANKLE CDS-LF rrrr. LAMI MICRODISC-LF ssss. HIP PINNING CDS-LF tttt. KNEE ARTHROSCOPY CDS-LF uuuu. UPPER EXTREMITY CDS-LF vvvv. SPINE CDS-LF wwww. SPINE CDS-LF xxxx. LOWER EXTREMITY/ELBOW CDS yyyy. HAND CDS zzzz. KNEE ARTHROSCOPY CDS aaaaa. SPINE CDS bbbbb. TOTAL HIP CDS ccccc. KNEE ARTHROSCOPY CDS ddddd. HAND CDS eeeee. TOTAL KNEE CDS-LF fffff. SPINE MODULE CDS ggggg. UPPER EXTREMITY CDS-LF hhhhh. TOTAL JOINT CDS iiiii. TOTAL JOINT CDS jjjjj. ORTHO TRAUMA CDS kkkkk. ACF CDS lllll. CRANIOTOMY CDS mmmmm. TOTAL JOINT CDS nnnnn. ARTHROSCOPY CDS ooooo. EXTREMITY CDS ppppp. PODIATRY CDS qqqqq. LAMINECTOMY CDS rrrrr. EXTREMITY CDS sssss. TOTAL KNEE CDS ttttt. TOTAL HIP CDS uuuuu. TOTAL KNEE vvvvv. ANTERIOR HIP wwwww. HAND WRIST FOREARM xxxxx. LOWER EXTREMITY yyyyy. TOTAL HIP zzzzz. TOTAL KNEE aaaaaa. SHOULDER ARTHROSCOPY bbbbbb. SHOULDER ARTHROSCOPY PK cccccc. LUMBAR LAMINECTOMY PACK dddddd. CRANIOTOMY PACK-LF eeeeee. OPEN SHOULDER PACK-LF ffffff. TOTAL HIP PACK-LF gggggg. TOTAL KNEE PACK-LF hhhhhh. SHOULDER ARTHROSCOPY PACK-LF iiiiii. EXTREMITY PACK jjjjjj. CLOSED HEART PEDS PACK kkkkkk. ORTHO MINOR PACK-LF llllll. FRACTURE TABLE PACK-LF mmmmmm. HAND - EDOC PACK-LF nnnnnn. FOOT LV - EDOC PACK-LF oooooo. SHOULDER - EDOC PACK-LF pppppp. FOOT ANKLE PACK-LF qqqqqq. OPEN HEART TRAY rrrrrr. SHOULDER PACK-LF ssssss. ROCKVILLE ASC EXTREMITY PACK tttttt. NEURO SPINE DRH PACK-LF uuuuuu. DRH ORTHOPEDIC I AND D PACK-LF vvvvvv. KNEE ARTHROSCOPY MIOSH PACK-LF wwwwww. HAND AND FOOT PACK-LF xxxxxx. SPINE BUNDLE PACK yyyyyy. MINOR ORTHOPEDIC PACK-LF zzzzzz. FEM POP PACK-LF aaaaaaa. LAMINECTOMY PACK-LF bbbbbbb. CRANIOTOMY PACK-LF ccccccc. MAJOR ORTHO PACK-LF ddddddd. HAND WRIST PACK-LF eeeeeee. TOSH PODIATRY PACK-LF fffffff. TOTAL HIP ARTHROPLASTY PACK-LF ggggggg. TOSH UPPER EXTREM MIOSH PK-LF hhhhhhh. OPEN HEART CHILDRENS PACK-LF iiiiiii. CRANIOTOMY PACK-LF jjjjjjj. SPINE HARPER PACK-LF kkkkkkk. CRANIOTOMY

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023

    Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIOTOMY CDS-LF, REF CDS780105M; 8) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 9) CRANIOTOMY CDS, REF CDS780166Q; 10) ANTERIOR CERVICAL CDS, REF CDS780205O; 11) ANTERIOR CERVICAL CDS, REF CDS780205P; 12) ANTERIOR CERVICAL CDS, REF CDS780205Q; 13) CRANIOTOMY CDS, REF CDS780206O; 14) CRANIOTOMY CDS, REF CDS780206P; 15) CRANIOTOMY CDS, REF CDS780206R; 16) NEURO-LAMI CDS, REF CDS780208I; 17) SHY CRANIOTOMY CDS, REF CDS780214M; 18) SHY CRANIOTOMY CDS, REF CDS780214N; 19) SPINAL CDS, REF CDS940087AL; 20) ORTHO SPINE PROCEDURE, REF CDS940875P; 21) CRANIOTOMY-RICHMOND, REF CDS980929Q; 22) CRANIOTOMY-RICHMOND, REF CDS980929R; 23) CRANIOTOMY-RICHMOND, REF CDS980929S; 24) CRANIOTOMY-RICHMOND, REF CDS980929T; 25) CRANIOTOMY-RICHMOND, REF CDS980929U; 26) OMC LUMBAR CDS, REF CDS981062I; 27) LAMINECTOMY CDS, REF CDS981229A; 28) ORTHO SPINE SUPPLEMENTAL CDS, REF CDS981742M; 29) CRANIOTOMY CDS, REF CDS981888X; 30) ANTERIOR CERVICAL DISC, REF CDS982023S; 31) ANTERIOR CERVICAL DISC, REF CDS982023T; 32) CRANIOTOMY, REF CDS982029R; 33) CRANIOTOMY, REF CDS982029S; 34) LAMI FUSION, REF CDS982035T; 35) LAMI FUSION, REF CDS982035U; 36) MICRODISCECTOMY, REF CDS982054W; 37) CRANIOTOMY CDS, REF CDS982480L; 38) CRANIOTOMY CDS, REF CDS982480M; 39) CRANIOTOMY CDS, REF CDS982480N; 40) CRANIOTOMY CDS, REF CDS982480O; 41) CRANIOTOMY CDS, REF CDS982480P; 42) LAMINECTOMY CDS, REF CDS982491L; 43) LAMINECTOMY CDS, REF CDS982491M; 44) LAMINECTOMY CDS, REF CDS982491N; 45) LAMINECTOMY CDS, REF CDS982491O; 46) LAMINECTOMY CDS, REF CDS982491P; 47) LAMINECTOMY CDS, REF CDS982491Q; 48) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563C; 49) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563D; 50) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563F; 51) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563G; 52) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563I; 53) NEURO SPINE CDS, REF CDS982683O; 54) NEURO SPINE CDS, REF CDS982683P; 55) NEURO SPINE CDS, REF CDS982683R; 56) NEURO SPINE CDS, REF CDS982683S; 57) NEURO SPINE CDS, REF CDS982683U; 58) NEURO SPINE CDS, REF CDS982683V; 59) NEURO SPINE, REF CDS982683W; 60) CRANIOTOMY, REF CDS982719P; 61) CRANIOTOMY, REF CDS982719Q; 62) CRANIOTOMY, REF CDS982719R; 63) CRANIOTOMY, REF CDS982719S; 64) CRANIOTOMY, REF CDS982719T; 65) CRANIOTOMY, REF CDS982719U; 66) CRANIOTOMY, REF CDS982719V; 67) CRANIOTOMY, REF CDS982719W; 68) ORTHO SPINE, REF CDS982735M; 69) ORTHO SPINE, REF CDS982735N; 70) ORTHO SPINE, REF CDS982735O; 71) ORTHO SPINE, REF CDS982735Q; 72) ORTHO SPINE, REF CDS982735R; 73) ORTHO SPINE, REF CDS982735S; 74) ORTHO SPINE, REF CDS982735U; 75) SPINAL CDS, REF CDS983037J; 76) SPINAL CDS, REF CDS983037K; 77) CRANIOTOMY CDS, REF CDS983094D; 78) CERVICAL SPINE CDS, REF CDS983108F; 79) LAMINECTOMY CDS, REF CDS983115F; 80) ZALE SPINE CDS, REF CDS983182F; 81) ZALE SPINE CDS, REF CDS983182G; 82) ZALE SPINE CDS, REF CDS983182I; 83) ZALE SPINE CDS, REF CDS983182J; 84) ZALE SPINE CDS, REF CDS983182K; 85) ZALE SPINE CDS, REF CDS983182L; 86) ZALE SPINE CDS, REF CDS983182M; 87) ZALE CRANIOTOMY CDS, REF CDS983188F; 88) ZALE CRANIOTOMY CDS, REF CDS983188K; 89) CRANIOTOMY, REF CDS983349J; 90) CRANIOTOMY, REF CDS983349K; 91) CRANIOTOMY, REF CDS983349L; 92) CRANIOTOMY, REF CDS983349M; 93) CRANIOTOMY, REF CDS983349N; 94) CRANIOTOMY, REF CDS983349O; 95) CRANI CDS, REF CDS983386G; 96) CRANIOTOMY CDS, REF CDS983467D; 97) CRANIOTOMY CDS, REF CDS983467F; 98) CRANIOTOMY CDS, REF CDS983467G; 99) CRANIOTOMY CDS, REF CDS983467I; 100) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476D; 101) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476F; 102) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476G; 103) LUMBAR LAMINECTOMY NEURO CDS, REF CDS98

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 8, 2025

    Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack Number CDS820081L ; 7) C-SECTION CDS , Pack Number CDS820103J ; 8) C-SECTION CDS , Pack Number CDS820103K ; 9) UVALDE C-SECTION CDS, Pack Number CDS820116F ; 10) UVALDE C-SECTION CDS, Pack Number CDS820116G ; 11) C-SECTION CDS , Pack Number CDS820136O ; 12) C-SECTION CDS , Pack Number CDS820136P ; 13) C-SECTION CDS , Pack Number CDS820136Q ; 14) C-SECTION CDS , Pack Number CDS820136R ; 15) C-SECTION CDS , Pack Number CDS820136S ; 16) C-SECTION CDS , Pack Number CDS820136T ; 17) C-SECTION CDS , Pack Number CDS820136U ; 18) C-SECTION CDS , Pack Number CDS820152F ; 19) C-SECTION CDS , Pack Number CDS820152G ; 20) C-SECTION CDS , Pack Number CDS820152I ; 21) C-SECTION CDS , Pack Number CDS980774J ; 22) C-SECTION , Pack Number CDS980774K ; 23) C-SECTION , Pack Number CDS980774L ; 24) C-SECTION , Pack Number CDS980774M ; 25) C-SECTION CDS WOR-LF, Pack Number CDS981707F ; 26) C-SECTION CDS , Pack Number CDS981777L ; 27) C-SECTION CDS , Pack Number CDS981777M ; 28) C-SECTION CDS , Pack Number CDS981777N ; 29) C-SECTION CDS-LF, Pack Number CDS982258F ; 30) C-SECTION CDS-LF, Pack Number CDS982258G ; 31) C-SECTION CDS-LF, Pack Number CDS982258I ; 32) C-SECTION CDS , Pack Number CDS982267F ; 33) C-SECTION CDS , Pack Number CDS982267G ; 34) C-SECTION CDS , Pack Number CDS982267I ; 35) C-SECTION CDS , Pack Number CDS982267J ; 36) C-SECTION CDS , Pack Number CDS982328J ; 37) C-SECTION CDS , Pack Number CDS982328K ; 38) C-SECTION CDS , Pack Number CDS982328L ; 39) C-SECTION CDS , Pack Number CDS982328M ; 40) C-SECTION CDS , Pack Number CDS982328O ; 41) C-SECTION CDS , Pack Number CDS982328P ; 42) C-SECTION CDS , Pack Number CDS982367G ; 43) C-SECTION COMBINED CDS, Pack Number CDS982398G ; 44) C-SECTION COMBINED CDS, Pack Number CDS982398I ; 45) C-SECTION CDS , Pack Number CDS982416O ; 46) C SECTION CDS CHS , Pack Number CDS982739F ; 47) C SECTION CDS CHS , Pack Number CDS982739J ; 48) C-SECTION CDS , Pack Number CDS983117C ; 49) C-SECTION CDS , Pack Number CDS983117D ; 50) C-SECTION CDS , Pack Number CDS983117F ; 51) C-SECTION CDS , Pack Number CDS983117G ; 52) C-SECTION PROCEDURE , Pack Number CDS983450I ; 53) C-SECTION PROCEDURE , Pack Number CDS983450J ; 54) C-SECTION PROCEDURE , Pack Number CDS983450K ; 55) C-SECTION PROCEDURE , Pack Number CDS983450L ; 56) C-SECTION PROCEDURE , Pack Number CDS983450M ; 57) C-SECTION CDS , Pack Number CDS983523D ; 58) C-SECTION CDS , Pack Number CDS983523F ; 59) C-SECTION CDS , Pack Number CDS983523G ; 60) C-SECTION CDS-LF, Pack Number CDS983869I ; 61) C-SECTION-LF, Pack Number CDS983869J ; 62) C-SECTION CDS , Pack Number CDS983897G ; 63) C-SECTION CDS , Pack Number CDS983897I ; 64) C-SECTION CDS , Pack Number CDS983934I ; 65) C-SECTION CDS , Pack Number CDS983998C ; 66) C-SECTION DELIVERY CDS, Pack Number CDS984018; 67) C-SECTION DELIVERY CDS, Pack Number CDS984018A ; 68) C-SECTION CDS , Pack Number CDS984554B ; 69) C SECTION CDS , Pack Number CDS984616A ; 70) C-SECTION CDS , Pack Number CDS984768D ; 71) C-SECTION CDS , Pack Number CDS984768F ; 72) C-SECTION , Pack Number CDS984902G ; 73) C-SECTION , Pack Number CDS984902I ; 74) C-SECTION , Pack Number CDS984902J ; 75) C-SECTION , Pack Number CDS984902K ; 76) C-SECTION CDS , Pack Number CDS985206B ; 77) C-SECTION CDS , Pack Number CDS985257G ; 78) C-SECTION CDS , Pack Number CDS985257I ; 79) C-SECTION CDS , Pack Number CDS985257J ; 80) C-SECTION CDS , Pack Number CDS985257L ; 81) C SECTION , Pack Number CDS985505G ; 82) C-SECTION , Pack Number CDS985560N ; 83) C-SECTION SET-UP PACK , Pack Number CDSOBL122F ; 84) C-SECTION SET-UP PACK , Pack Number CDSOBL122G ; 85) C-SECTION SET-UP PACK , Pack Number CD

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W; 7) TOTAL HIP, REF CDS920027X; 8) TOTAL HIP, REF CDS920027Y; 9) TOTAL KNEE CDS-LF, REF CDS940047AF; 10) TOTAL KNEE CDS-LF, REF CDS940047AG; 11) TOTAL HIP CDS-LF, REF CDS940048AF; 12) TOTAL HIP CDS-LF, REF CDS940048AG; 13) TOTAL HIP CDS-LF, REF CDS940048AI; 14) TOTAL KNEE, REF CDS940072W; 15) TOTAL KNEE, REF CDS940072Y; 16) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 17) TOTAL KNEE CDS, REF CDS940842Y; 18) TOTAL HIP CDS, REF CDS940843AA; 19) FRACTURE TABLE-LF, REF CDS940857K; 20) FRACTURE TABLE-LF, REF CDS940857L; 21) EXTREMITY-LF, REF CDS940860P; 22) EXTREMITY-LF, REF CDS940860Q; 23) KNEE/SHOULDER, REF CDS940911Q; 24) TOTAL HIP CDS, REF CDS940963Y; 25) SHOULDER CDS, REF CDS941065L; 26) TOTAL JOINT-LF, REF CDS941167M; 27) TOTAL JOINT-LF, REF CDS941167N; 28) LOWER EXTREMITY CDS-LF, REF CDS980666I; 29) LOWER EXTREMITY CDS-LF, REF CDS980666J; 30) TOTAL HIP-LF, REF CDS980788O; 31) TOTAL HIP-LF, REF CDS980788P; 32) EXTREMITY KIT, REF CDS981314R; 33) EXTREMITY KIT, REF CDS981314S; 34) ORIF HIP KIT, REF CDS981318T; 35) ORIF HIP KIT, REF CDS981318U; 36) TOTAL HIP KIT, REF CDS981320V; 37) TOTAL HIP KIT, REF CDS981320W; 38) TOTAL KNEE KIT, REF CDS981323AA; 39) TOTAL KNEE KIT, REF CDS981323Y; 40) BI LATERAL KNEE KIT, REF CDS981324T; 41) UPPER EXTREMITY CDS-LF, REF CDS981564G; 42) UPPER EXTREMITY CDS-LF, REF CDS981564I; 43) LAMI, REF CDS981886X; 44) CRANIOTOMY CDS, REF CDS981888W; 45) CRANIOTOMY CDS, REF CDS981888X; 46) TOTAL KNEE CDS, REF CDS981926D; 47) TOTAL KNEE PROCEDURE-LF, REF CDS982082F; 48) BHMC SYSTEM HIP KIT, REF CDS982396N; 49) BAPTIST NORTH TOTAL KNEE CDS, REF CDS982404M; 50) BAP NORTH SHOULDER CDS, REF CDS982406M; 51) BAP NORTH UNIV EXTREMITY CDS, REF CDS982408K; 52) TOTAL KNEE CDS, REF CDS982823Q; 53) LOWER EXTREMITY CDS-LF, REF CDS982927M; 54) LUMBAR LAMINECTOMY CDS-LF, REF CDS982928O; 55) TOTAL HIP REPLACEMENT CDS-LF, REF CDS982929K; 56) TOTAL KNEE REPLACEMENT CDS-LF, REF CDS982931L; 57) UPPER EXTREMITY-LF, REF CDS982932K; 58) LOWER EXTREMITY CDS, REF CDS982943Q; 59) LOWER EXTREMITY CDS, REF CDS982943R; 60) LOWER EXTREMITY CDS, REF CDS982943S; 61) TOTAL KNEE, REF CDS982986T; 62) SPECIALIZED HIP CDS, REF CDS983030V; 63) EXTREMITY CDS, REF CDS983031Q; 64) ZALE SPINE CDS, REF CDS983182J; 65) ZALE SPINE CDS, REF CDS983182K; 66) ZALE CRANIOTOMY CDS, REF CDS983188K; 67) DR GILL'S CDS, REF CDS983189G; 68) ZALE TOTAL KNEE CDS, REF CDS983194I; 69) ZALE TOTAL KNEE CDS, REF CDS983194J; 70) ZALE TOTAL KNEE CDS, REF CDS983194K; 71) ZALE TOTAL KNEE CDS, REF CDS983194L; 72) ZALE TOTAL HIP CDS, REF CDS983195I; 73) ZALE TOTAL HIP CDS, REF CDS983195J; 74) ZALE TOTAL HIP CDS, REF CDS983195K; 75) ZALE EXTREMITY CDS, REF CDS983199K; 76) ZALE TOTAL SHOULDER CDS, REF CDS983203J; 77) ZALE TOTAL SHOULDER CDS, REF CDS983203K; 78) ZALE TOTAL SHOULDER CDS, REF CDS983203L; 79) ORTHO EXTREMITY CDS, REF CDS983408G; 80) ORTHO-CV CDS, REF CDS983415G; 81) PODIATRY CDS, REF CDS983416D; 82) PODIATRY CDS, REF CDS983416G; 83) ORTHO EXTREMITY, REF CDS983468O; 84) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476J; 85) SITTING CERVICAL CDS, REF CDS983480G; 86) ORTHO SPINE, REF CDS983482L; 87) ARTHROSCOPY SHOULDER, REF CDS983485L; 88) EXTREMITY-LF, REF CDS983487K; 89) ACL-LF, REF CDS983490M; 90) PODIATRY CDS, REF CDS983610L; 91) TOTAL JOINT-LF, REF CDS983863F; 92) UPPER EXTREMITY CDS, REF CDS983907K; 93) UPPER EXTREMITY CDS, REF CDS983907L; 94) LOWER EXTREMITY CDS, REF CDS983909O; 95) LOWER EXTREMITY CDS, REF CDS983909P; 96) GENERAL ORTHO CDS, REF CDS983915L; 97) GENERAL ORTHO CDS, REF CDS983915M; 98) MAJOR ORTHO, REF CDS984253L; 99) LOWER EXTREMTIY, REF CDS984254K; 100) LOWER EXTREMTIY, REF CDS98425

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 11, 2024

    Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS780056L ; 6) SHUNT CDS-LF, Pack Number CDS780103K ; 7) NEURO CDS , Pack Number CDS780108T ; 8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ; 9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ; 10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ; 11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ; 12) NEURO CDS , Pack Number CDS780162AA; 13) NEURO CDS , Pack Number CDS780162AB; 14) NEURO CDS , Pack Number CDS780162AC; 15) NEURO CDS , Pack Number CDS780162AD; 16) NEURO CDS , Pack Number CDS780162X ; 17) NEURO CDS , Pack Number CDS780162Y ; 18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ; 19) BASIC NEURO PACK, Pack Number CDS780202L ; 20) BASIC NEURO PACK, Pack Number CDS780202O ; 21) BASIC NEURO PACK, Pack Number CDS780202P ; 22) BASIC NEURO PACK, Pack Number CDS780202Q ; 23) BASIC NEURO PACK, Pack Number CDS780202R ; 24) NEURO-LAMI CDS, Pack Number CDS780208D ; 25) NEURO-LAMI CDS, Pack Number CDS780208F ; 26) NEURO CDS, Pack Number CDS780230K; 27) NEURO CDS , Pack Number CDS780230K ; 28) VP SHUNT, Pack Number CDS840193U ; 29) NEURO CDS-LF, Pack Number CDS980853N ; 30) VP SHUNT CDS-LF , Pack Number CDS981084K ; 31) VP SHUNT CDS-LF , Pack Number CDS981084L ; 32) VP SHUNT CDS-LF , Pack Number CDS981084M ; 33) NEURO KIT , Pack Number CDS981327N ; 34) NEURO KIT , Pack Number CDS981327O ; 35) NEURO KIT , Pack Number CDS981327P ; 36) NERVE STIMULATOR, Pack Number CDS981579N ; 37) NEURO MINOR CDS , Pack Number CDS981708K ; 38) VP SHUNT CDS, Pack Number CDS981740F ; 39) VP SHUNT CDS, Pack Number CDS981740J ; 40) VP SHUNT CDS, Pack Number CDS981740K ; 41) VP SHUNT CDS, Pack Number CDS981740KH; 42) MICRO DISC CDS, Pack Number CDS981886P ; 43) MICRO DISC CDS, Pack Number CDS981886R ; 44) MICRO DISC CDS, Pack Number CDS981886S ; 45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ; 46) NEURO CDS , Pack Number CDS982603L ; 47) NEURO CDS , Pack Number CDS982603M ; 48) NEURO CDS , Pack Number CDS982603N ; 49) NEURO SPINE CDS , Pack Number CDS982683Q ; 50) MAJOR NEURO , Pack Number CDS982704K ; 51) MAJOR NEURO , Pack Number CDS982704M ; 52) MAJOR NEURO , Pack Number CDS982704N ; 53) NEURO CDS CHS-LF, Pack Number CDS982745D ; 54) NEURO CDS CHS-LF, Pack Number CDS982745F ; 55) NEURO CDS CHS-LF, Pack Number CDS982745G ; 56) AV SHUNT CDS, Pack Number CDS983098D ; 57) AV SHUNT CDS, Pack Number CDS983098F ; 58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ; 59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ; 60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ; 61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ; 62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ; 63) VP SHUNT, Pack Number CDS983366J ; 64) VP SHUNT, Pack Number CDS983366M ; 65) VP SHUNT, Pack Number CDS983366N ; 66) VP SHUNT, Pack Number CDS983366P ; 67) NEURO CDS-LF, Pack Number CDS983383F ; 68) NEURO CDS-LF, Pack Number CDS983383G ; 69) NEURO CDS-LF, Pack Number CDS983383I ; 70) NEURO CDS-LF, Pack Number CDS983383J ; 71) AV SHUNT CDS, Pack Number CDS983792C ; 72) AV SHUNT CDS, Pack Number CDS983792D ; 73) ANTERIOR NEURO CDS, Pack Number CDS983882C ; 74) ANTERIOR NEURO CDS, Pack Number CDS983882D ; 75) POSTERIOR NEURO CDS , Pack Number CDS983885C ; 76) POSTERIOR NEURO CDS , Pack Number CDS983885D ; 77) POSTERIOR NEURO CDS , Pack Number CDS983885F ; 78) NEURO CDS , Pack Number CDS983981D ; 79) NEURO CDS , Pack Number CDS983981F ; 80) NEURO CDS , Pack Number CDS983981I ; 81) NEURO CDS , Pack Number CDS983981J ; 82) NEURO CDS , Pack Number CDS983981K ; 83) NEURO CDS , Pack Number CDS983981L ; 84) CRANI NEURO CDS , Pack Number CDS984172F ; 85) PUH NEURO EEA CDS , Pack Number CDS984297G ; 86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ; 87) ME

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS780161L ; 4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ; 5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ; 6) CAROTID CDS-LF, Pack Number CDS840056N ; 7) CAROTID-LF, Pack Number CDS860039J ; 8) T & A PROCEDURE-LF, Pack Number CDS860047X ; 9) THORACOTOMY CDS , Pack Number CDS920065R ; 10) EAR CDS , Pack Number CDS980089L ; 11) EAR CDS , Pack Number CDS980089M ; 12) EAR CDS , Pack Number CDS980089N ; 13) EAR CDS , Pack Number CDS980089O ; 14) ENDOSCOPY , Pack Number CDS980201R ; 15) TYMPANOPLASTY , Pack Number CDS980203R ; 16) TYMPANOPLASTY , Pack Number CDS980203S ; 17) TYMPANO CDS , Pack Number CDS980374M ; 18) TYMPANO CDS , Pack Number CDS980374O ; 19) TYMPANO CDS , Pack Number CDS980374P ; 20) THORACOTOMY CDS , Pack Number CDS980446T ; 21) SINUS CDS , Pack Number CDS980579D ; 22) EENT-HEAD AND NECK, Pack Number CDS980809K ; 23) EENT-HEAD AND NECK, Pack Number CDS980809L ; 24) EENT-HEAD AND NECK, Pack Number CDS980809M ; 25) FESS PROCEDURE, Pack Number CDS981185B ; 26) CDS981571P, Pack Number CDS981571P ; 27) SINUS CDS-LF, Pack Number CDS981692J ; 28) EAR CDS , Pack Number CDS981985F ; 29) MAJOR EAR , Pack Number CDS982016Q ; 30) MAJOR EAR , Pack Number CDS982016R ; 31) MAJOR EAR , Pack Number CDS982016S ; 32) MAJOR EAR , Pack Number CDS982016T ; 33) SINUS , Pack Number CDS982020O ; 34) SINUS , Pack Number CDS982020P ; 35) SINUS , Pack Number CDS982020R ; 36) NASAL/SEPTAL, Pack Number CDS982049M; 37) NASAL/SEPTAL, Pack Number CDS982049O; 38) T&A CDS-LF, Pack Number CDS982091I ; 39) EAR-EENT CDS, Pack Number CDS982307F ; 40) EAR-EENT CDS, Pack Number CDS982307G ; 41) EAR-EENT CDS, Pack Number CDS982307J ; 42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ; 43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ; 44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ; 45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ; 46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ; 47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ; 48) EAR CDS-LF, Pack Number CDS982612B ; 49) T AND A CDS MRH , Pack Number CDS982622L ; 50) CAROTID , Pack Number CDS982638J ; 51) NASAL CDS , Pack Number CDS982655C ; 52) NASAL CDS , Pack Number CDS982655D ; 53) NASAL CDS , Pack Number CDS982655F ; 54) NECK THYROID, Pack Number CDS982692M ; 55) NECK THYROID, Pack Number CDS982692N ; 56) NECK THYROID, Pack Number CDS982692O ; 57) TYMPANOPLASTY , Pack Number CDS982720N ; 58) TYMPANOPLASTY , Pack Number CDS982720P ; 59) TYMPANOPLASTY , Pack Number CDS982720Q ; 60) TYMPANOPLASTY , Pack Number CDS982720R ; 61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ; 62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ; 63) SINUS CDS-1 , Pack Number CDS982901F ; 64) MIDDLE EAR CDS, Pack Number CDS982938J ; 65) MIDDLE EAR CDS, Pack Number CDS982938K ; 66) MIDDLE EAR CDS, Pack Number CDS982938L ; 67) MIDDLE EAR CDS, Pack Number CDS982938O ; 68) SMR/RHINO CDS , Pack Number CDS982939L ; 69) SMR/RHINO CDS , Pack Number CDS982939M ; 70) SMR/RHINO CDS , Pack Number CDS982939N ; 71) SMR/RHINO CDS , Pack Number CDS982939Q ; 72) SMR/RHINO CDS , Pack Number CDS982939R ; 73) SMR/RHINO CDS , Pack Number CDS982939S ; 74) T&A CDS , Pack Number CDS982944J ; 75) T&A CDS , Pack Number CDS982944K ; 76) MINOR EAR , Pack Number CDS982989K ; 77) MINOR EAR , Pack Number CDS982989L ; 78) MINOR EAR , Pack Number CDS982989M ; 79) MINOR EAR , Pack Number CDS982989N ; 80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ; 81) ENT CDS , Pack Number CDS983035J ; 82) ENT CDS , Pack Number CDS983035L ; 83) ENT CDS , Pack Number CDS983035M ; 84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ; 85) CHP TYMPMASTOID CDS, Pack Number CDS983088J; 86) HEAD & NECK CDS , Pack Number CDS983126B ; 87) HEAD & NECK CDS , Pack Number CDS983126C ; 88) CAROTID CDS-

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CDS830039AK; 6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ; 7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ; 8) LABOR & DELIVERY, Pack Number CDS830054P ; 9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ; 10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ; 11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ; 12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ; 13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ; 14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ; 15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ; 16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ; 17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ; 18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ; 19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ; 20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ; 21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ; 22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ; 23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ; 24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ; 25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ; 26) DELIVERY CDS, Pack Number CDS830199K ; 27) DELIVERY CDS, Pack Number CDS981282O ; 28) OB PROCEDURE-LF , Pack Number CDS981335B ; 29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ; 30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ; 31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ; 32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ; 33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ; 34) VAGINAL MAJOR , Pack Number CDS982689O ; 35) VAGINAL MAJOR , Pack Number CDS982689P ; 36) VAGINAL MAJOR , Pack Number CDS982689Q ; 37) VAGINAL MAJOR , Pack Number CDS982689R ; 38) DELIVERY PROCEDURE, Pack Number CDS982761F ; 39) DELIVERY PROCEDURE, Pack Number CDS982761G ; 40) DELIVERY PROCEDURE, Pack Number CDS982761I ; 41) DELIVERY PROCEDURE, Pack Number CDS982761J ; 42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ; 43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ; 44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ; 45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ; 46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ; 47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ; 48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ; 49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ; 50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ; 51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959; 52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ; 53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ; 54) LABOR & DELIVERY CDS, Pack Number CDS983116C ; 55) LABOR & DELIVERY CDS, Pack Number CDS983116D ; 56) LABOR & DELIVERY CDS, Pack Number CDS983116F ; 57) LABOR & DELIVERY CDS, Pack Number CDS983116G ; 58) LABOR & DELIVERY CDS, Pack Number CDS983116I ; 59) MINOR VAGINAL CDS , Pack Number CDS983119B ; 60) VAGINAL MINOR , Pack Number CDS983268J ; 61) VAGINAL MINOR , Pack Number CDS983268L ; 62) GYN VAGINAL CDS , Pack Number CDS983528J ; 63) ACH MAJOR VAGINAL , Pack Number CDS983641F ; 64) ACH MAJOR VAGINAL , Pack Number CDS983641G ; 65) VAG HYST CDS, Pack Number CDS983697F ; 66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ; 67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ; 68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ; 69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ; 70) OB/GYN CDS, Pack Number CDS984173G ; 71) OB GYN, Pack Number CDS984173I ; 72) GROTH VAGINAL CDS , Pack Number CDS984201P ; 73) GROTH VAGINAL CDS , Pack Number CDS984201Q ; 74) GROTH VAGINAL CDS , Pack Number CDS984201R ; 75) GROTH VAGINAL CDS , Pack Number CDS984201U ; 76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ; 77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ; 78) VAGINAL DELIVERY CDS, Pack

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M;

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , Pack Number CDS760051AC; 5) LAPAROSCOPY CDS , Pack Number CDS760051AD; 6) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057G ; 7) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057I ; 8) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057J ; 9) ABDOMINAL LAPAROSCOPY , Pack Number CDS760057K ; 10) CYSTO PROCEDURE , Pack Number CDS760062P ; 11) CYSTO PROCEDURE , Pack Number CDS760062Q ; 12) LAPAROSCOPY CDS , Pack Number CDS830216F ; 13) FETAL SURGERY CDS-LF, Pack Number CDS840214Q ; 14) MINOR LAPAROTOMY CDS, Pack Number CDS860016P ; 15) MINOR LAPAROTOMY CDS, Pack Number CDS860016Q ; 16) MINOR LAPAROTOMY CDS, Pack Number CDS860016R ; 17) MINOR LAPAROTOMY CDS, Pack Number CDS860016S ; 18) THOROCOTOMY , Pack Number CDS860040I ; 19) LAPAROTOMY CDS #31-RF , Pack Number CDS860062Q ; 20) LAPAROTOMY CDS #31-RF , Pack Number CDS860062R ; 21) LAPAROTOMY CDS #31-RF , Pack Number CDS860062S ; 22) GYN LAP , Pack Number CDS860087K ; 23) GYN LAP , Pack Number CDS860087M ; 24) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107P ; 25) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107Q ; 26) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107R ; 27) LAPAROSCOPIC GASTRIC BYPASS , Pack Number CDS860107S ; 28) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108K ; 29) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108L ; 30) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108M ; 31) GENERAL LAPAROSCOPIC CDS, Pack Number CDS860108N ; 32) LAP GASTRIC BYPASS CDS, Pack Number CDS860146J ; 33) LAP GASTRIC BYPASS CDS, Pack Number CDS860146K ; 34) LAP GASTRIC BYPASS CDS, Pack Number CDS860146L ; 35) LAP GASTRIC BYPASS CDS, Pack Number CDS860146M ; 36) ABDOMINAL ANEURYSM PROCEDURE, Pack Number CDS860181D ; 37) LAPAROSCOPY CDS , Pack Number CDS860194F ; 38) LAPAROSCOPY CDS , Pack Number CDS860194G ; 39) LAPAROSCOPY CDS , Pack Number CDS860194I ; 40) LAPAROSCOPY CDS , Pack Number CDS860229G ; 41) LAPAROSCOPY CDS-LF, Pack Number CDS860235G ; 42) LAPAROSCOPY CDS-LF, Pack Number CDS860235I ; 43) LAPAROSCOPY CDS-LF, Pack Number CDS860235J ; 44) BARI GASTRECTOMY CDS, Pack Number CDS860237AA; 45) BARI GASTRECTOMY CDS, Pack Number CDS860237AB; 46) BARI GASTRECTOMY CDS, Pack Number CDS860237AC; 47) BARI GASTRECTOMY CDS, Pack Number CDS860237X ; 48) BARI GASTRECTOMY CDS, Pack Number CDS860237Y ; 49) CYSTO , Pack Number CDS902753F ; 50) LAPAROSCOPIC CDS, Pack Number CDS920043T ; 51) BASIC LAPAROSCOPY CDS , Pack Number CDS920080P ; 52) BASIC LAPAROSCOPY CDS , Pack Number CDS920080Q ; 53) BASIC LAPAROSCOPY CDS , Pack Number CDS920080R ; 54) BASIC LAPAROSCOPY CDS , Pack Number CDS920080S ; 55) BASIC LAPAROSCOPY CDS , Pack Number CDS920080T ; 56) LAPAROSCOPIC, Pack Number CDS920082X ; 57) LAPAROSCOPIC, Pack Number CDS920082Y ; 58) LAPAROSCOPY CDS-LF, Pack Number CDS920104F ; 59) LAPAROSCOPY CDS-LF, Pack Number CDS920104G ; 60) LAPAROSCOPY CDS-LF, Pack Number CDS920104I ; 61) LAPAROSCOPY CDS-LF, Pack Number CDS920126AC; 62) GENERAL LAPAROSCOPY , Pack Number CDS930027T ; 63) GENERAL LAPAROSCOPY , Pack Number CDS930027U ; 64) GENERAL LAPAROSCOPY , Pack Number CDS930027V ; 65) LAP CHOLE CDS-LF, Pack Number CDS930030T ; 66) LAP CHOLE CDS-LF, Pack Number CDS930030U ; 67) LAP CHOLE , Pack Number CDS930089AA; 68) LAP CHOLE CDS , Pack Number CDS930111AA; 69) LAP CHOLE CDS , Pack Number CDS930111AB; 70) LAP CHOLE CDS-LF, Pack Number CDS930117J ; 71) MINOR BASIC-LF, Pack Number CDS930120G ; 72) MINOR BASIC-LF, Pack Number CDS930120I ; 73) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125R ; 74) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125S ; 75) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125T ; 76) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125U ; 77) GENERAL LAPAROSCOPY PROCEDURE , Pack Number CDS930125V ; 78)

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ; 7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ; 8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ; 9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ; 10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ; 11) GYN LAP , Pack Number CDS860087L ; 12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ; 13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ; 14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ; 15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ; 16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ; 17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ; 18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ; 19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ; 20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH; 21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ; 22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ; 23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ; 24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ; 25) LAVH CDS, Pack Number CDS920130J ; 26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ; 27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ; 28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ; 29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ; 30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ; 31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ; 32) GYN LAPAROSCOPIC, Pack Number CDS930224I ; 33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ; 34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ; 35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ; 36) ROBOTIC , Pack Number CDS980523M ; 37) ROBOTIC GYN , Pack Number CDS980647K ; 38) GYN LAP PROCEDURE , Pack Number CDS980810O ; 39) GYN LAP PROCEDURE , Pack Number CDS980810P ; 40) GYN LAP PROCEDURE , Pack Number CDS980810Q ; 41) GYN LAPAROSCOPY , Pack Number CDS980843G ; 42) GYN LAPAROSCOPY , Pack Number CDS980843I ; 43) DAVINCI PROCEDURE , Pack Number CDS980864O ; 44) DAVINCI PROCEDURE , Pack Number CDS980864P ; 45) GYN MAJOR CDS , Pack Number CDS980998J ; 46) GYN MAJOR , Pack Number CDS980998L ; 47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ; 48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ; 49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ; 50) PELVISCOPY CDS, Pack Number CDS981546F ; 51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ; 52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ; 53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ; 54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ; 55) GYN DAVINCI CDS , Pack Number CDS981606F ; 56) ROBOTIC PACK-LF , Pack Number CDS981757Q ; 57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ; 58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ; 59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ; 60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ; 61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ; 62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ; 63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ; 64) ROBOTIC CDS , Pack Number CDS981882W ; 65) ROBOTIC CDS , Pack Number CDS981882X ; 66) LITHOTOMY CDS , Pack Number CDS981897S ; 67) LITHOTOMY CDS , Pack Number CDS981897T ; 68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ; 69) GYN LAPAROSCOPY , Pack Number CDS982032U ; 70) GYN LAPAROSCOPY , Pack Number CDS982032V ; 71) GYN LAPAROSCOPY , Pack Number CDS982032W ; 72) GYN LAPAROSCOPY , Pack Number CDS982032X ; 73) GYN LAPAROSCOPY , Pack Number CDS982032Y ; 74) ROBOTIC , Pack Number CDS982046V ; 75) ROBOTIC MAJOR , Pack Number CDS982046X ; 76) ROBOTIC MAJOR , Pack Number CDS982046Y ; 77) LIVER PROCEDURE , Pack Number CDS982106J ; 78) ROBOTIC PROCEDURE , Pack Number CDS982128P ; 79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ; 80

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K; 13) TOTAL KNEE CDS, Model Number: CDS981454L; 14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K; 15) TOTAL KNEE, Model Number: CDS981505O; 16) TOTAL KNEE, Model Number: CDS981505P; 17) TOTAL KNEE, Model Number: CDS981505Q; 18) TOTAL KNEE, Model Number: CDS981505R; 19) OR LAMINECTOMY CDS, Model Number: CDS981858F; 20) LAMI FUSION, Model Number: CDS982035W; 21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O; 22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P; 23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S; 24) TOTAL HIP CDS, Model Number: CDS983036K; 25) TOTAL KNEE CDS, Model Number: CDS983042K; 26) LOWER EXTREMITY CDS, Model Number: CDS983049K; 27) ZALE SPINE CDS, Model Number: CDS983182G; 28) TOTAL KNEE CDS, Model Number: CDS983297M; 29) SITTING CERVICAL CDS, Model Number: CDS983480G; 30) SHOULDER CDS, Model Number: CDS983581K; 31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G; 32) TOTAL HIP CDS, Model Number: CDS983840I; 33) TOTAL JOINT CDS-LF, Model Number: CDS983863D; 34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C; 35) TOTAL JOINT, Model Number: CDS983903D; 36) GB TOTAL KNEE, Model Number: CDS984147K; 37) GB LOWER EXTREMITY, Model Number: CDS984156L; 38) LOWER EXTREMTIY, Model Number: CDS984254K; 39) LOWER EXTREMTIY, Model Number: CDS984254L; 40) LOWER EXTREMTIY, Model Number: CDS984254M; 41) LAMI MICRODISC-LF, Model Number: CDS984527I; 42) EXTREMITY CDS-LF, Model Number: CDS984607G; 43) EXTREMITY CDS-LF, Model Number: CDS984607I; 44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C; 45) TOTAL JOINT CDS, Model Number: CDS985202B; 46) TOTAL JOINT CDS, Model Number: CDS985202C; 47) TRAUMA-LF, Model Number: CDS985279K; 48) ARTHROSCOPY CDS, Model Number: CDS985316A; 49) EXTREMITY CDS, Model Number: CDS985317C; 50) EXTREMITY CDS, Model Number: CDS985317D; 51) EXTREMITY CDS, Model Number: CDS985317F; 52) EXTREMITY CDS, Model Number: CDS985317G; 53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J; 54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W; 55) JOINT ASPIRATION KIT, Model Number: DYKM1161; 56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106; 57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137; 58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A; 59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141; 60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A; 61) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141B; 62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C; 63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143; 64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144; 65

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 25, 2026

    See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ; 6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ; 7) LEFT HEART TRAY , Pack Number 00-401880I ; 8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ; 9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ; 10) ADVANTEC-MLD, Pack Number 00-500510D ; 11) ADVANTEC-MLD, Pack Number 00-500510F ; 12) KIT ANGIO CSTM-WALKER, Pack Number 129969; 13) DIAGNOSTIC KIT, Pack Number 147943; 14) MSC - CRESCENT MEDICAL, Pack Number 149155; 15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111; 16) OPEN HEART CDS, Pack Number CDS840015AK; 17) OPEN HEART CDS, Pack Number CDS840015AL; 18) OPEN HEART CDS, Pack Number CDS840015AM; 19) OPEN HEART CDS, Pack Number CDS840015AN; 20) OPEN HEART CDS, Pack Number CDS840015AO; 21) OPEN HEART CDS, Pack Number CDS840015AP; 22) OPEN HEART CDS, Pack Number CDS840015AQ; 23) OPEN HEART CDS, Pack Number CDS840015AQ; 24) OPEN HEART CDS, Pack Number CDS840016AD; 25) OPEN HEART CDS, Pack Number CDS840016AD; 26) OPEN HEART CDS, Pack Number CDS840023R ; 27) OPEN HEART CDS, Pack Number CDS840023S ; 28) OPEN HEART CDS, Pack Number CDS840023T ; 29) AAA CDS , Pack Number CDS840076AC; 30) OFF PUMP CABG CDS , Pack Number CDS840087AB; 31) OFF PUMP CABG CDS , Pack Number CDS840087AD; 32) OFF PUMP CABG CDS , Pack Number CDS840087AF; 33) OFF PUMP CABG CDS , Pack Number CDS840087AG; 34) OFF PUMP CABG CDS , Pack Number CDS840087AI; 35) OFF PUMP CABG CDS , Pack Number CDS840087AJ; 36) OFF PUMP CABG CDS , Pack Number CDS840087AK; 37) OFF PUMP CABG CDS , Pack Number CDS840087AL; 38) OPEN HEART CDS, Pack Number CDS840094L ; 39) OPEN HEART CDS, Pack Number CDS840094M ; 40) OPEN HEART CDS, Pack Number CDS840094N ; 41) OPEN HEART CDS, Pack Number CDS840094P ; 42) OPEN HEART CDS, Pack Number CDS840108J ; 43) OPEN HEART CDS, Pack Number CDS840108K ; 44) OPEN HEART CDS, Pack Number CDS840132N ; 45) OPEN HEART CDS, Pack Number CDS840132O ; 46) OPEN HEART CDS, Pack Number CDS840144O ; 47) OPEN HEART CDS, Pack Number CDS840144P ; 48) OPEN HEART CDS, Pack Number CDS840144Q ; 49) OPEN HEART CDS, Pack Number CDS840144Q ; 50) OPEN HEART CDS, Pack Number CDS840145S ; 51) OPEN HEART CDS, Pack Number CDS840145T ; 52) OPEN HEART CDS, Pack Number CDS840145U ; 53) OPEN HEART, Pack Number CDS840150R ; 54) OPEN HEART, Pack Number CDS840150S ; 55) OPEN HEART, Pack Number CDS840150T ; 56) OPEN HEART, Pack Number CDS840150U ; 57) OPEN HEART, Pack Number CDS840150V ; 58) PACEMAKER CDS , Pack Number CDS840162S ; 59) PACEMAKER CDS , Pack Number CDS840162T ; 60) PACEMAKER CDS , Pack Number CDS840162U ; 61) PACEMAKER CDS , Pack Number CDS840162V ; 62) OPEN HEART CDS, Pack Number CDS840171AA; 63) OPEN HEART CDS, Pack Number CDS840171AB; 64) OPEN HEART CDS, Pack Number CDS840171AC; 65) OPEN HEART CDS, Pack Number CDS840171AD; 66) HEART CDS , Pack Number CDS840179M ; 67) HEART CDS, Pack Number CDS840179M ; 68) MINOR VASCULAR PACK , Pack Number CDS840184M ; 69) MINOR VASCULAR PACK , Pack Number CDS840184N ; 70) MINOR VASCULAR PACK , Pack Number CDS840184O ; 71) MINOR VASCULAR PACK, Pack Number CDS840184P; 72) OPEN HEART PACK , Pack Number CDS840185S ; 73) OPEN HEART PACK , Pack Number CDS840185T ; 74) OPEN HEART PACK , Pack Number CDS840185U ; 75) OPEN HEART PACK , Pack Number CDS840185V ; 76) OPEN HEART PACK , Pack Number CDS840185W ; 77) VALVE PACK, Pack Number CDS840187S ; 78) VALVE PACK, Pack Number CDS840187T ; 79) OPEN HEART, Pack Number CDS840189R ; 80) MAJOR VASCULAR, Pack Number CDS840195T ; 81) MAJOR VASCULAR, Pack Number CDS840195U ; 82) CABG-LF , Pack Number CDS840231Q ; 83) CABG-LF , Pack Number CDS840231R ; 84) CABG-LF , Pack Number CDS840231S ; 85) CABG-LF , Pack Number CDS840231T ; 86) MAJOR VASCU

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024