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

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    B HCG-CHECK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DENRACLE DENTAL ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    TEMPORARY TITANIUM ANEURYSM CLIP

    FDA 510(k)
    FDA Class 2 ·Neurology

    T-PAL SPACER APPLICATOR INNER SHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code MAX·May 18, 2016

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2012

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2010

    ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·August 14, 2019

    3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·June 1, 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