BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    RIVAL PTA DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139244087·UNITY KNEE™ PS-C INSERT - Size 7 x 22mm

    Headless Compression Screw

    FDA UDI
    I.T.S. GmbH·09120047297445·Headless Compression Screw, Cannulated, D=2.0mm...

    M-Flex®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020241·Blue Silicone Tungsten Hurst Esophageal Dilator...

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517071658·

    NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TELAVANCIN 30 UG, BBL SENSI-DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VERCISE GENUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·December 23, 2024

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    REVEAL LINQ

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DSI·August 15, 2014

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 15, 2008

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022