BEUDAMED
    13 results · 21ms · 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 ×

    EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517443175·SpheRx® II Hook, 8mm Reduced Tip Wide

    8V5 Transducer

    FDA UDI
    SIEMENS MEDICAL SOLUTIONS USA, INC.·04056869003184·

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704515152·

    Perfect Fit

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377022401·Interface Cable, FastTrack, SUM

    PROFEMUR TAPERED HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT VERIO FLEX METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·April 4, 2019

    NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION OFFSET

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·November 21, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    SPINAL PEDICLE FIXATION

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·July 22, 2013

    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026

    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