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

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    Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS

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

    PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)

    FDA 510(k)
    FDA Class 2 ·Dental

    EXTRACTOR RX RETRIEVAL BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FGE·October 1, 2008

    PRIME BIG WHEEL STRETCHER, 30"

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

    PROTECTA XT CRT-D

    FDA Adverse Event
    Death ·IPG MFG SWITZERLAND·Product code NIK·June 26, 2013

    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