BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Capiflo 5001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM

    PBP TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 24, 2011

    5.0MM TI LOCKING HEAD SCREWSELF-TAPPING 75MM

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code KTT·November 3, 2014

    PALINDROME HSI 19/36 KIT VT CE

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MSD·July 2, 2013

    OT VERIO 2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE GMBH·Product code NBW·February 4, 2020

    OT VERIO 2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE GMBH·Product code NBW·February 4, 2020

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    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