BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    LungProtect

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

    CD HORIZON SPIRE™Z Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169177536·CADDY 9240650 BOTTOM LID

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015375480·REVISION LOCKING SCREW L65.0MM D4.0MM

    devemed

    FDA UDI
    devemed GmbH·04061644017225·Mini sliding caliper 0-100 mm

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101216·FRANCIS FOREIGN BODY SPUD

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015374988·REVISION LOCKING SCREW L65.0MM D4.0MM STERILE

    Reicodent

    FDA UDI
    devemed GmbH·04061644050161·Mini dental caliper 0-100 mm

    BONAMATES SERIES

    FDA 510(k)
    FDA Class 2 ·Dental

    HIVOX ELECTRIC STIMULATOR OTC TENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    1.55MM X 10MM FLUTED TWIST DRL

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

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017

    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