BEUDAMED
    63 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C

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

    ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B

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

    ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A

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

    SQ40S Blood Transfusion Filter

    FDA Enforcement
    Class II ·Ongoing·GVS TM, Inc·January 28, 2026

    Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B

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

    (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

    FDA Enforcement
    Class II ·Ongoing·ARROW INTERNATIONAL Inc.·October 2, 2024

    HipLOC CHS Plate/Lag Screw Introducer

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 2, 2016

    CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018