BEUDAMED
    17 results · 36ms · Sources: EU EUDAMED, US FDA

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    DISTAL VOLAR RADIUS PLATING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169605190·SPACER 2112345 OLIF25 20MM 12 DEG 12X45

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636119·CoRoent Ant TLIF PEEK, 11x12x34mm 15°

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006243·4500A SERIES NON HTD PNT

    ARGELOY SUNRAY (100g)

    FDA UDI
    ARGEN CORPORATION, THE·D818112345·Base metal alloy

    AOS TIBIAL NAIL 12mm x 34.5cm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016321·

    Plateau TI

    FDA UDI
    Life Spine, Inc.·00190837077464·Modified Hudson T-Handle

    NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ONE TOUCH PROFILE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·February 15, 2002

    EXACTA DISPOSABLE DRAINAGE SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC NEUROSURGERY·Product code JXG·November 18, 2010

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 14, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    MICROPUNCTURE ACCESS SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DRE·May 25, 2011

    FLEXI SEAL SIGNAL (FMS)

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code KNT·October 11, 2016

    UNITIP CATHETER FOR HR GI

    FDA Adverse Event
    Malfunction ·UNISENSOR USA INC·Product code FFX·January 16, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024