BEUDAMED
    14 results · 15ms · 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 Status: Ongoing ×

    Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW, MitraClip G4 Clip Delivery System XT CE/CDS0702-XT, MitraClip G4 Clip Delivery System XTW CE/CDS0702-XTW, MitraClip G4 Clip Delivery Sys NT ROW/CDS0705-NT, MitraClip G4 Clip Delivery Sys NTW ROW/CDS0705-NTW, MitraClip G4 Clip Delivery Sys XT ROW/CDS0705-XT, MitraClip G4 Clip Delivery Sys XTW ROW/CDS0705-XTW, TriClip XT Clip Delivery Sys CE/TCDS0202-XT, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip XT Clip Delivery Sys ROW/TCDS0205-XT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT, TriClip G4 NT Delivery System CE/TCDS0302-NT, TriClip G4 NTW Delivery System CE/TCDS0302-NTW, TriClip G4 XT Delivery System CE/TCDS0302-XT, TriClip G4 XTW Delivery System CE/TCDS0302-XTW, TriClip G4 NT Delivery System ROW/TCDS0305-NT, TriClip G4 NTW Delivery System ROW/TCDS0305-NTW, TriClip G4 XT Delivery System ROW/TCDS0305-XT, TriClip G4 XTW Delivery System ROW/TCDS0305-XTW, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT. For cardiac procedures.

    FDA Enforcement
    Class II ·Ongoing·Abbott Vascular·October 26, 2022

    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018

    Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·May 15, 2024

    1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·February 2, 2022

    Intelli-C, Left side suspended Tabletop, REF: 03400010

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    Intelli-C, Right side suspended Tabletop, REF: 03400000

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300; e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A; f) EPIV PROCEDURE TRAY, Model Number IVS3825; g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A; h) RADIOLOGY TRAY, Model Number MNS11625; i) BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A; j) NGHS EVOR ANGIO PACK, Model Number NG410A; k) PICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A; l) RADIOLOGY SPECIALS PACK, Model Number PHS479840M; m) HYBRID OR PACK, Model Number SYNJ10303B; n) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A; o) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B; p) VC PROCEDURE KIT, Model Number VC-PK

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LLC·April 5, 2023

    Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 18, 2023

    Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile; (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile; (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile; (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile; (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile; (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile; (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile; (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile; (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile; (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile; (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile; (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile; (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile; (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile; (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile; (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile; (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile; (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile; (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile; (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile; (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile; (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile; (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile; (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile; (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile; (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile; (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile; (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile; (32) Presource EVAR, Cat. SCV30EVTHE, Trillium Health Centre, Sterile; (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile; (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 18, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B; d. AAA PACK, Model Number: DYNJ44918C; e. AAA PACK - TEAM 3, Model Number: DYNJ44847G; f. ABLATION PACK, Model Number: DYNJ62540, DYNJ64068; g. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658A; h. ACCESS KIT, Model Number: DYNDH1159A; i. ACCESS PACK, Model Number: DYNJ69017; j. ACCESSORY KIT, Model Number: DYNJ901348D; k. ADULT CORONARY PACK, Model Number: DYNJV0275F; l. ADULT CVC MAX BARRIER KIT-LF, Model Number: DYNJ38714B; m. ALL PURPOSE TRAY FOAKS, Model Number: DYNJ63576, DYNJ63576A; n. AMINO KIT; Model Number: DYNDH1649; o. AMNIOCENTESIS TRAY, Model Number: DYNDH1420; p. ANGIO STANDARD PACK-LF, Model Number: DYNJ0370436Q; q. ANGIO TRAY, Model Number: DYNJ23438J; r. ANGIOGRAM PACK, Model Number: DYNJ47004B; s. ANGIOGRAM TRAY, Model Number: DYNJ33638I; t. ANGIO-VASCULAR, Model Number: DYNJ24272B; u. ARTERIAL PACK, Model Number: DYNJ51340D; v. ARTERIO-VENOUS CDS, Model Number: CDS984186C; w. ASPIRATION TRAY, Model Number: DYNDH1467; x. ASPIRE EXACT TRAY, Model Number: DYNJRA1716, DYNJRA1716A; y. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299L; z. BASIC PACK, Model Number: DYNJ37460A, DYNJ42691, DYNJ52122B, DYNJ52171, DYNJ55456, DYNJ55457, DYNJ81343; aa. BASIC PROCEDURE PACK, Model Number: DYNJ53122B; bb. BASIC VEIN PACK, Model Number: DYNJ58650; cc. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; dd. BGMC LIVER TRANSPLANT, Model Number: DYNJ9664651D; ee. BIOPSY TRAY, Model Number: DYNDH1340; ff. BLOCK KIT, Model Number: DYNJRA1145; gg. BLOCK SUPPLIES NDL CNTR, Model Number: DYNJRA1755; hh. BREAST ULTRASOUND PROCEDURE TR, Model Number: DYNDL1596A; ii. BUNDLE KIT, Model Number: DYNJ49737B, DYNJ49737C; jj. C V MAJOR PACK, Model Number: DYNJ64861; kk. CABG UNIVERSITY HOSP PACK-LF, Model Number: DYNJ0375705L; ll. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640; mm. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; nn. CHP TRANSPLANT CDS, Model Number: CDS983082I, CDS983082J; oo. CLINIC PACK, Model Number: DYNJRA1578; pp. CLOSURE CDS, Model Number: CDS983704G, CDS983704I; qq. CLOSURE FAST PACK UNIV, Model Number: DYNJ53482A; rr. CLOSURE PACK, Model Number: DYNJ54437A, DYNJ54437C, DYNJ57514, DYNJ60804; ss. CLOSURE PACK-LF, Model Number: DYNJ0807503M; tt. CLOSURE PROCEDURE, Model Number: DYNJ59206; uu. CLOSURE PROCEDURE PACK, Model Number: DYNJ66741; vv. CLOSURE PROCEDURE PKSJO-LF, Model Number: DYNJ35409F; ww. CLOT RETRIEVAL PACK, Model Number: DYNJ56140B; xx. CLOVIS MINOR IR PROCEDURE-LF, Model Number: DYNJ61067; yy. COMMANDO PACK MSH-LF, Model Number: DYNJ48525D; zz. CONTINUOUS BLOCK, Model Number: DYNJRA0960B; aaa. COPS PROCEDURE PACK-LF, Model Number: DYNJ68923A; bbb. CRMC MINOR IR PROCEDURE PK-LF, Model Number: DYNJ61099, DYNJ61099A; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710; ddd. CV ACCESS PACK WRO-LF, Model Number: DYNJ41875B; eee. CV CDS, Model Number: CDS985395C; fff. CV MINOR CDS, Model Number: CDS984100T; ggg. CV PACK, Model Number: DYNJ45074B; hhh. CVC PACK, Model Number: DYNJ44010; iii. CVL PACK, Model Number: DYNJ00281N; jjj. CVOR CDS-LF, Model Number: CDS840198V; kkk. CYSTO PACK SMGH-LF, Model Number: DYNJ41915A; lll. DAVIES PHALLOPLASTY PACK, Model Number: DYNJ52185F; mmm. DAVINCI, Model Number: DYNJ906543A; nnn. DBD-BASIC PACK, Model Number: DYNJ55458; ooo. DBD-BIOPSY PACK-LF, Model Number: DYNJ0747885F; ppp. DBD-DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069M; qqq. DBD-ECMO MODULE PACK, Model Number: DYNJ55669F; rrr. DBD-EVLA PACK, Model Number: DYNJ6

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069Q; 5. MINOR MB PACK-LF, Medline Kit Number/SKU DYNJ0429303L; 6. ENDOSCOPIC SKULL BASE PACK-LF, Medline Kit Number/SKU DYNJ0753948J; 7. RR-H&N FREEFLAP BLCKWELL PK-LF, Medline Kit Number/SKU DYNJ0785741K; 8. MINIMALLY INVASIVE PACK-LF, Medline Kit Number/SKU DYNJ0843063K; 9. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320K; 10. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320M; 11. MLD PACK, Medline Kit Number/SKU DYNJ19521Q; 12. SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ34623C; 13. PMD PACK SURG CNTR-LF, Medline Kit Number/SKU DYNJ35305G; 14. LARYNGOSCOPY PACK, Medline Kit Number/SKU DYNJ37547D; 15. FUNCTIONAL SINUS ENDOSCOPY, Medline Kit Number/SKU DYNJ40406A; 16. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645C; 17. FREE FLAP B PACK, Medline Kit Number/SKU DYNJ40648G; 18. MINOR ENT PACK, Medline Kit Number/SKU DYNJ50808A; 19. SINUS ENDOSCOPY PACK-LF, Medline Kit Number/SKU DYNJ52062; 20. LAP PACK, Medline Kit Number/SKU DYNJ52116B; 21. LAP PACK, Medline Kit Number/SKU DYNJ52116C; 22. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719C; 23. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719D; 24. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917I; 25. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917J; 26. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917K; 27. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917L; 28. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917N; 29. LARYNGOSCOPY WEST PACK, Medline Kit Number/SKU DYNJ58324A; 30. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558A; 31. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558B; 32. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213; 33. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213D; 34. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213G; 35. EENT PACK, Medline Kit Number/SKU DYNJ68366B; 36. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447; 37. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447A; 38. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447B; 39. UNIVERSITY DISC PACK, Medline Kit Number/SKU DYNJ69824; 40. MAJOR PACK, Medline Kit Number/SKU DYNJ81325; 41. MAJOR PACK, Medline Kit Number/SKU DYNJ81325A; 42. MAJOR PACK, Medline Kit Number/SKU DYNJ81325B; 43. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751; 44. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751A; 45. FLAP PACK, Medline Kit Number/SKU DYNJ85359; 46. ENDO PACK, Medline Kit Number/SKU DYNJ86125; 47. ENDO PACK, Medline Kit Number/SKU DYNJ86125A; 48. ENT PACK, Medline Kit Number/SKU DYNJ88448; 49. MAJOR BACK PACK, Medline Kit Number/SKU DYNJ88470; 50. UROLOGY DAVINCI, Medline Kit Number/SKU DYNJ901572O; 51. LARYNGOSCOPY/BRONCH, Medline Kit Number/SKU DYNJ902985F; 52. KIT FREE FLAP MOSES, Medline Kit Number/SKU DYNJ905366B; 53. FLAP, Medline Kit Number/SKU DYNJ907076C; 54. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165; 55. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165A; 56. ENDOSCOPY, Medline Kit Number/SKU DYNJ909512; 57. DIEP FLAP, Medline Kit Number/SKU DYNJ910120A; 58. DIEP BREAST, Medline Kit Number/SKU DYNJ911086; 59. WILLIAMS GENERAL, Medline Kit Number/SKU DYNJ940735F; 60. ROBOTIC LAP PROSTATE PACK CHS, Medline Kit Number/SKU DYNJT3101; 61. CUH FLAP ACCESSORY PACK, Medline Kit Number/SKU DYNJT3243.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026