BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BASE

    FDA UDI
    Nuvasive, Inc.·00887517701404·BASE HL Trial, 10x34x24mm 20°

    Zavation

    FDA UDI
    Zavation LLC·00842166171602·Self Tapping Variable Screw, 4mmx20

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111788·Modular Tibia Augment Size 2 x 4mm

    Solstice

    FDA UDI
    Life Spine, Inc.·00190837031411·4.0mm SOLSTICE® Smooth Shaft Poly Screw, 20mm

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776348342·Yasargil Bayonet Forceps

    ZAVATION

    FDA UDI
    Zavation LLC·00842166117327·Polyaxial Screw 4.0mm x 20mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690131045·High Performance Revision Tibia Augment, Size 2...

    MEMORYMATE HEARING AID WITH PMC PROGRAMMER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    G-T 1000

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

    SUPER SHEATH

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DYB·January 28, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 10, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2014

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    Vanguard XP Tibial Tray 75 mm Item # 195251

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Recall
    Terminated ·Omni Life Science·Product code JWH·August 9, 2012

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015