BEUDAMED
    12 results · 11ms · Sources: EU EUDAMED, US FDA

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    CryoValve, Aortic Valve & Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·January 16, 2004

    CryoValve, Pulmonary Valve & Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·January 16, 2004

    Synergraft CryoValve, Aortic Valve & Conduit SG

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·January 16, 2004

    Applied Blunt Tip Trocar Models C0717 and C0718

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code KXN·September 17, 2004

    ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.

    FDA Recall
    Terminated ·Datascope Interventional Products Division·Product code MCW·July 12, 2004

    Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code DRE·June 16, 2004

    Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model M001482501, REF/Catalog No. 48-250.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code DRE·June 16, 2004

    CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.

    FDA Recall
    Terminated ·GVI Technology Partners·Product code IYX·January 16, 2004

    Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code HWC·December 27, 2004

    B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code LID·December 14, 2001

    TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). On August 5, 2004 an additional 38 lots were added to this recall, the following TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Part Numbers correspond to the lot numbers listed at the end of the code information below. US part# H7493897024250 H7493897032270 H7493897020300 H7493897020350 H7493897032300 H7493897020350 H7493897024300 H7493897020300 H7493897020300 H7493897032350 H7493897020250 H7493897020270 H7493897024300 H7493897032350 H7493897032270 H7493897020350 H7493897024300 H7493897024250 H7493897024250 H7493897020300 H7493897032350 H7493897032350 H7493897024350 H7493897024250 H7493897024250 H7493897016300 H7493897032350 H7493897024350 H7493897016350 H7493897032300 H7493897016350 H7493897016350 H7493897024350 H7493897016250 H7493897016250 H7493897024300 H7493897024350 H7493897016250 OUS part# H7493800132270 H7493800132270 H7493800132350 H7493800132270 H7493800124350

    FDA Recall
    Terminated ·Boston Scientific Scimed·Product code NIQ·July 1, 2004

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018