BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037306918·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STANDARD ...

    HUMERIS 135

    FDA UDI
    FX SOLUTIONS·03701037301678·HUMERAL CUP SYMMETRIC STANDARD PE/TA6V Ø40+6 / ...

    Tiger Shark System

    FDA UDI
    Choice Spine, LP·00840996180986·24Lx08H-6 DEG, TRIAL, TI SHARK TL

    IBS IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Ion 3D

    FDA 510(k)
    FDA Unclassified ·Unknown

    OPTETRACK TIBIAL INSERT

    FDA Adverse Event
    EXACTECH, INC.·Product code HSH·November 14, 2008

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWS·August 28, 2011

    DUROM US ACETABULAR COMPONENT 52/46 L

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code KWA·July 17, 2013

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020