BEUDAMED
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    ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

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

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000856984·IMPLANT 6240664 ANATOMIC 16X14X6MM

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994305206·IMPLANT 6240664 ANATOMIC 16X14X6MM

    ANATOMIC PEEK CERVICAL FUSION SYSTEM

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994366467·IMPLANT 4240664 ANATOMIC C 16X14X 6MM

    Anatomic PEEK™ Cervical Fusion System with Nanotechnology

    FDA UDI
    NANOVIS SPINE, LLC·00814216028136·ANATOMIC PEEK w/ Nano 16 x 14 x 6 x 4.6°

    HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 11, 2026

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 25, 2008

    *

    FDA Adverse Event
    Malfunction ·*·Product code GCJ·September 2, 2011

    1.85MM X 16MM FLUTED ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014