BEUDAMED
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    ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.

    FDA Enforcement
    Class II ·Ongoing·Radiometer Medical ApS·July 31, 2024

    Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE KIT, Model Number: DYNDA2076C; 6) CARDIAC CATH PACK-LF, Model Number: DYNJ0150605AC; 7) CATH LAB PACK-LF, Model Number: DYNJ0648473Y; 8) NBMC CATH PACK-LF, Model Number: DYNJ0803367I; 9) ANGIO PACK-LF, Model Number: DYNJ0954970I; 10) CARDIAC CATH PACK, Model Number: DYNJ19946M; 11) CATH LAB PACK, Model Number: DYNJ30955I; 12) CATH LAB PACK, Model Number: DYNJ31773K; 13) CATH PACK-LF, Model Number: DYNJ33061D; 14) DB CCL OAKWOOD PACK-LF, Model Number: DYNJ33620D; 15) CARDIAC CATH PACK MRH-LF, Model Number: DYNJ35300M; 16) CATH LAB PK, Model Number: DYNJ35643C; 17) CARDIAC CATH PACK-LF, Model Number: DYNJ39066B; 18) CATH PACK-LF, Model Number: DYNJ43101C; 19) OR ANGIO PACK-LF, Model Number: DYNJ43415D; 20) OR ANGIO PACK-LF, Model Number: DYNJ43415F; 21) ANGIOPLASTY PACK, Model Number: DYNJ44700J; 22) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 23) RADIOLOGICAL PACK, Model Number: DYNJ44889O; 24) CARDIAC CATH PACK, Model Number: DYNJ47370B; 25) ANGIOGRAPHY PACK, Model Number: DYNJ53129D; 26) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ56772G; 27) DR. MOHINDRA PACK, Model Number: DYNJ57602G; 28) NE ENDO VASCULAR PACK, Model Number: DYNJ57940B; 29) CARDIAC CATH PACK - Q1, Model Number: DYNJ58048C; 30) OR ANGIO, Model Number: DYNJ59931B; 31) LPCH PERRY CATH PACK, Model Number: DYNJ67378C; 32) HOSPITAL REGIONAL DE CONCEPCIO, Model Number: DYNJ67918A; 33) CATH LAB PACK, Model Number: DYNJ68633; 34) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197B; 35) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197C; 36) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197D; 37) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197F; 38) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197G; 39) BASIC CARDIAC CATH PACK, Model Number: DYNJ81593B; 40) UMC EL PASO CATH PACK, Model Number: DYNJ83089; 41) DR. MOHINDRA PACK, Model Number: DYNJ83819A; 42) VZ VAS/ANG PACK, Model Number: DYNJ83981; 43) WCPN CARDIOLOGY PACK, Model Number: DYNJ84539; 44) CATH LAB, Model Number: DYNJ85511; 45) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJT1520K; 46) ANGIOGRAPHY TRAY, Model Number: MNS9130; 47) CVC BUNDLE KIT, Model Number: ECVC6225A; 48) CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A

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

    Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A; 6) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4B; 7) VEIN PROCEDURE KIT, Model Number:DYNDA2076C; 8) CARDIAC CATH PACK-LF, Model Number:DYNJ0150605AC; 9) CARDIAC CATH PACK-LF, Model Number:DYNJ0368386D; 10) CATH LAB PACK-LF, Model Number:DYNJ0648473Y; 11) NBMC CATH PACK-LF, Model Number:DYNJ0803367I; 12) RADIOLOGY PACK-LF, Model Number:DYNJ0928124C; 13) ANGIO PACK-LF, Model Number:DYNJ0954970I; 14) SPECIALS TRAY RADIOLOGY, Model Number:DYNJ16803D; 15) CARDIAC CATH PACK, Model Number:DYNJ19946M; 16) CATH LAB PACK, Model Number:DYNJ30955I; 17) CATH LAB PACK, Model Number:DYNJ31773K; 18) CATH PACK-LF, Model Number:DYNJ33061D; 19) DB CCL OAKWOOD PACK-LF, Model Number:DYNJ33620D; 20) CARDIAC CATH PACK MRH-LF, Model Number:DYNJ35300M; 21) CATH LAB PK, Model Number:DYNJ35643C; 22) CARDIAC CATH PACK-LF, Model Number:DYNJ39066B; 23) ANGIOGRAPHY PACK, Model Number:DYNJ42134G; 24) CATH PACK-LF, Model Number:DYNJ43101C; 25) OR ANGIO PACK-LF, Model Number:DYNJ43415D; 26) OR ANGIO PACK-LF, Model Number:DYNJ43415F; 27) ANGIOPLASTY PACK, Model Number:DYNJ44700J; 28) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ44850J; 29) RADIOLOGICAL PACK, Model Number:DYNJ44889O; 30) CARDIAC CATH PACK, Model Number:DYNJ47370B; 31) ANGIOGRAPHY PACK, Model Number:DYNJ53129D; 32) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ56772G; 33) DR. MOHINDRA PACK, Model Number:DYNJ57602G; 34) NE ENDO VASCULAR PACK, Model Number:DYNJ57940B; 35) CARDIAC CATH PACK - Q1, Model Number:DYNJ58048C; 36) OR ANGIO, Model Number:DYNJ59931B; 37) LPCH PERRY CATH PACK, Model Number:DYNJ67378C; 38) HOSPITAL REGIONAL DE CONCEPCIO, Model Number:DYNJ67918A; 39) CATH LAB PACK, Model Number:DYNJ68633; 40) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197B; 41) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197C; 42) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197D; 43) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197F; 44) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197G; 45) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197I; 46) BASIC CARDIAC CATH PACK, Model Number:DYNJ81593B; 47) CATH LAB PACK, Model Number:DYNJ83073; 48) UMC EL PASO CATH PACK, Model Number:DYNJ83089; 49) DR. MOHINDRA PACK, Model Number:DYNJ83819A; 50) VZ VAS/ANG PACK, Model Number:DYNJ83981; 51) WCPN CARDIOLOGY PACK, Model Number:DYNJ84539; 52) CATH LAB, Model Number:DYNJ85511; 53) CATH LAB, Model Number:DYNJ85511A; 54) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJT1520K; 55) CVC BUNDLE KIT, Model Number:ECVC6225A; 56) CVC 3L 7F 20CM VANTEX, Model Number:ECVC7265A; 57) ANGIOGRAPHY TRAY, Model Number:MNS9130

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

    ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·September 20, 2023

    ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·May 4, 2022

    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro/8/9/10000) Part Number: 0020302600

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·October 27, 2021

    Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·May 26, 2021

    Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·May 26, 2021

    ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·April 5, 2023

    ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·April 5, 2023

    ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·April 5, 2023

    ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·April 5, 2023

    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·October 27, 2021

    BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

    FDA Enforcement
    Class II ·Ongoing·Miach Orthopaedics·November 19, 2025

    Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848L ANTERIOR CERVICAL DYNJ901355J ARTHROSCOPY DYNJ908193B ARTHROSCOPY PACK-LF DYNJ42963M DYNJ52268B ARTHROSCOPY SHOULDER DYNJ908684A BACK CDS-LF CDS983364G BACK PACK DYNJT4339 CDH SPINE PACK DYNJ908828D CERVICAL CDS DYNJ903477J CMC ORTHO BACK TRAY SYNJ10272B CRANIOTOMY DYNJ911853 CRANIOTOMY ROOSEVELT PACK DYNJ58358F CUSTOM HAND PACK-LF DYNJ0537135V CUSTOM SPINAL PACK DYNJT7544 DISCECTOMY PACK DYNJ86770 DJ ORTHO SPINE DYNJ48980M EXTREMITY PACK-LF DYNJT4161 FOOT PACK DYNJ53179D GENERAL ORTHO-ACNW DYNJ84891 GILMORE SHOULDER SCOPE PACK DYNJ58002 GV LUMBAR LAMINECTOMY PK DYNJ46938L HAND PACK DYNJ63113B DYNJ69662A DYNJT5855 HAND-LF DYNJ903263B KIT LAMINECTOMY DYNJ908806C KNEE ARTHROSCOPY DYNJ902056C DYNJ904846I KNEE ARTHROSCOPY-LF DYNJ905871F KNEE SCOPE DYNJ906986G LAMINECTOMY DYNJ904847K DYNJ909505D LAMINECTOMY CDS CDS983115K LAMINECTOMY CERVICAL DISC-LF DYNJ905286G LAMINECTOMY NEURO PACK DYNJ58356F LAMINECTOMY SPINE DYNJ904139L LOWER EXTREMITY PACK DYNJ63114C LUMBAR CERVICAL PACK-LF DYNJ0101088G LUMBAR LAMI DYNJ905020J LUMBAR LAMINECTOMY DYNJ53707 LUMBAR LAMINECTOMY PACK DYNJT4386 MAIN/LAMINECTOMY PACK-LF DYNJ0565499AN NJ SPINE SPECIALIST PACK DYNJ58706F OHOW SPINE-BACK PACK DYNJ910097A ORTHO NECK CDS-LF CDS983134C ORTHO PACK-LF DYNJ37202G ORTHO SPINE DYNJ40221G OSC BEACH CHAIR SHOULDER-LF DYNJ905282C PACC PETRIE ACL ADD ON PACK-LF DYNJ58290D PACK,ARTHROSCOPY ASC DYNJ65484A PACK,POSTERIOR SPINAL FUSION DYNJ906892B PAD LATERAL SPINE DYNJ902158L DYNJ902158M PAD POSTERIOR SPINE DYNJ902142L PK-SPINE DYNJ58259A PODIATRY PACK DYNJ62288D POST SPINE PACK DYNJ20509R POSTERIOR SPINAL FUSION DYNJ903250B RFT ARTHROSCOPY PACK DYNJ43956C RFT SHOULDER PACK-NOBLE DYNJ36331D SA SHOULDER #2 BORDEN DYNJ56501A SHOULDER DYNJ900893M DYNJ904184I SHOULDER ARTHROSCOPY DYNJ904842G SHOULDER PACK DYNJ83483 SHOULDER PACK-LF DYNJ42973N SHOULDER SCOPE PACK NTX DYNJ68399C SPINAL PACK DYNJ49692G SPINE DYNJ910451A SPINE PACK DYNJ20147O DYNJ84971 DYNJ86044A DYNJ86308C DYNJ88917 DYNJS3069 DYNJT4163 DYNJT8396 ST CHARLES TOTAL HIP DYNJ909593C TOTAL HIP DYNJ910906D TOTAL HIP PACK DYNJ64156B TOTAL JOINT DYNJ904186G TOTAL KNEE PACK DYNJ60967 DYNJ61409A WMC ORTHO SPINE WMC-LF DYNJ902528M XLIF DYNJ910795B

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D; c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F; d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C; e) LAMINECTOMY, Pack Number DYNJ908091B; f) PODIATRY, Pack Number DYNJ908092C; g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B; h) CRANI, Pack Number DYNJ908097A; i) HIP PINNING, Pack Number DYNJ908102B; j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B; k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B; m) HAND-LF, Pack Number DYNJ908425; n) TOTAL JOINT, Pack Number DYNJ908660A; o) MERCY TIFFIN HAND, Pack Number DYNJ909734; p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738; q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740; r) ACL-WHSC, Pack Number DYNJ910074A; s) EXTREMITY-WHSC, Pack Number DYNJ910077; t) EXTREMITY-WHSC, Pack Number DYNJ910077A; u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A; v) MICRODISC, Pack Number DYNJ910370; w) MTHZ TOTAL HIP, Pack Number DYNJC9311L

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

    Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAVIGATIONAL SPINE FUSION, REF DYNJ45153B; 7) FEET, ELBOW, AND ANKLE TEGH-LF, REF DYNJ46719B; 8) PLASTIC HAND PACK TEGH-LF, REF DYNJ46739B; 9) CVL INSERTION KIT-LF, REF DYNJ48587A; 10) CVL INSERTION KIT-LF, REF DYNJ48587A; 11) ENSEMBLE SURPLUS LCA-LF, REF DYNJ48892C; 12) EXTREMITY PACK, REF DYNJ49301B; 13) ACL ACCESSORY PACK, REF DYNJ50952F; 14) SPINAL INJECTION PACK, REF DYNJ51383F; 15) FTMC ARTHROS BASIC SETUP-LF, REF DYNJ54602A; 16) MINOR EXTREMITY PACK, REF DYNJ55324G; 17) MINOR EXTREMITY PACK, REF DYNJ55324G; 18) D-SPINE SUPPLEMENT PACK, REF DYNJ58115A; 19) EXTREMITY PACK, REF DYNJ62877; 20) AHT LG KNEE ROLL, REF DYNJ64823; 21) CUSTOM ORTHO PACK, REF DYNJ83675; 22) DR SUNDAR SCS KIT, REF DYNJ85288A; 23) CENTRAL SCS TRIAL PACK, REF DYNJ85503; 24) TOTAL KNEE CDS-LF, REF DYNJ909569; 25) EXTREMITY PACK, REF SYNJ10253B; 26) CARROLLTON HIP FX, REF SYNJ910003A; 27) ARTHROSCOPY, REF SYNJ910004C

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024

    Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN; 5) SCC/SPOC HAND & FOOT PACK, Kit SKU DYNJ27164Q; 6) ORTHO SPINE, Kit SKU DYNJ40221G; 7) URO GYN PACK, Kit SKU DYNJ45311J; 8) LAMINECTOMY PACK, Kit SKU DYNJ46330C; 9) DJ ORTHO SPINE, Kit SKU DYNJ48980M; 10) CERVICAL PACK, Kit SKU DYNJ52995F; 11) NORTH BACK FUSION PACK-LF, Kit SKU DYNJ56483L; 12) KNEE ARTHROSCOPY CHRISTUS, Kit SKU DYNJ61200B; 13) KNEE ARTHROSCOPY PACK-LF, Kit SKU DYNJ66150; 14) HIP PACK, Kit SKU DYNJ66630; 15) OHNS FREE FLAP A PACK, Kit SKU DYNJ69065F; 16) LUMBAR PACK, Kit SKU DYNJ69113C; 17) LAMINECTOMY PACK, Kit SKU DYNJ69401D; 18) LAMINECTOMY PACK, Kit SKU DYNJ81013D; 19) HIP/SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ84275A; 20) FLASC ACL PACK, Kit SKU DYNJ88971; 21) SPINE PACK MERCY GALENA, Kit SKU DYNJ89943; 22) SPINAL FUSION MT CARMEL, Kit SKU DYNJ900173J; 23) HAND, Kit SKU DYNJ904945G; 24) LAMINECTOMY, Kit SKU DYNJ909505D; 25) SHOULDER SPLIT, Kit SKU DYNJ910543F; 26) SHOULDER SPLIT, Kit SKU DYNJ910543G; 27) CRANIOTOMY PACK, Kit SKU DYNJT4724; 28) SPINE PACK, Kit SKU DYNJT5184.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 4, 2026