BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDPOR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    STAYHEALTHY BODY COMPOSITION MONITOR-BCM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·July 10, 2024

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 1, 2008

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 26, 2013

    CHARLOTTE(R) CLAW(R) SCREW

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRS·August 4, 2011

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. 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,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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