BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    UniSmile Clear Aligner System

    FDA 510(k)
    FDA Class 2 ·Dental

    RADIAL ARTERY COMPRESSION TOURNIQUET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACL TIGHTROPE DOUBLE BUNDLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

    QUICKFLEX XL LV LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·January 13, 2014

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·June 26, 2013

    BASIC CONFIGURATION MODEL 6100 BASE

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 29, 2011

    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024