BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    Clearform Aligners

    FDA 510(k)
    FDA Class 2 ·Dental

    VTS1000

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IDENTIFY XL DR

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

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·June 26, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·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