BEUDAMED
    16 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.

    IPL Hair Removal Device (SYL001AZ, SYL002AZ)

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

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517220349·ARM15T CoCr Rod, 35mm Conventional PB

    Minit®

    FDA UDI
    ZIMMER SPINE, INC.·00889024334120·

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")

    Eonis SCID-SMA kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SSW CARBIDE CAD CAM

    FDA UDI
    Ss White Burs, Inc.·D690SSWWIE25303520012·CAD/CAM CARBIDE LAZER SHARP SSWWIE-253035-20-01...

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024042940·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024042964·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024042933·

    ITST®

    FDA UDI
    Zimmer, Inc.·00889024042957·

    ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) - 35 MM

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC·Product code GDW·December 4, 2008

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD.·Product code MMI·August 31, 2011

    GO BED PLUS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 29, 2013

    Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·June 10, 2015

    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