BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    REUSABLE STIMULATING ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK111201·DD tempMED are pre-colored dental milling blank...

    AOS TIBIAL NAIL 11mm x 27.0cm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016185·

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·July 29, 2013

    AUTOMATED CORE BIOPSY DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·January 7, 2022

    INSULIN PUMP

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 2, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 2, 2016

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 2, 2019

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 16, 2016

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 8, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 23, 2015

    JUVEDERM ULTRA PLUS XC/LIDO (VOLUME UNK)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·May 8, 2013

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·September 23, 2014

    EON RECHARGEABLE IPG

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 12, 2016

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018