BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    Citrepore™

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464054817·HEARLINK 3030 MNR T R BR/TP

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015375404·REVISION LOCKING SCREW L45.0MM D4.0MM

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015374902·REVISION LOCKING SCREW L45.0MM D4.0MM STERILE

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361029205·Ø12mm X 50mm Hybrid Fusion Screw, Gen II

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869604369·MOSS 100 Ti Rod, Ø4.5x450mm

    Spud

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

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·April 4, 2011

    KEELER KAPTURE SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996

    FDA 510(k)
    FDA Class 2 ·Immunology

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 20, 2012

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 20, 2012

    QUADRA R FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    1.55MM X 10MM FLUTED TWIST DRL

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

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·March 21, 2011

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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