BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    NAVARRE PERCUTANEOUS BILIARY DRAINAGE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Burr Hole Reservoir

    FDA UDI
    INTEGRA NEUROSCIENCES IMPLANT (FRANCE)·10381780034315·The Burr Hole Reservoir is a component of a cen...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192077·Apex Revision Knee Reamer - Zimmer 11mm

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668106907·SINSKEY TYING FORCEPS CURVED

    Zuma™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981037567·Trial, 26mm x 24mm x 10mm, 8 Deg. Zuma™ Trials ...

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221117519·3M™ Victory Series™ Second Molar Bands, 955-110...

    Buccal Tubes

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746083921·DB TUBE INCONEL LR 1ST MOL 022 NON-CONV T=0 R=0...

    DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LIATEST(R) AT III TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 11, 2013

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 24, 2014

    Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCM; 5) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAS; 6) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAT; 7) Cardiovascular Procedure Kit, Catalog Number SANOCAENSA; 8) Cardiovascular Procedure Kit, Catalog Number SCV29ANCCA; 9) Left Heart Kit, Catalog Number SAN73LHKCC; 10) Left Heart Kit, Catalog Number SAN73LHKC6

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·July 17, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021