BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PULSE

    FDA UDI
    Nuvasive, Inc.·00195377060778·PULSE Kit, 10cm Hip Pin Non-fiducial

    Prehma

    FDA UDI
    Keystone Industries·H66810504101·Sterilization Pouches 5-1/4 X 10 (BX 200)

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0104100·Caddie Lid, Tulip and Domino Connectors

    JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Widex

    FDA UDI
    Widex A/S·05706069687002·Widex EVOKE E-IM (Dark brown ) 110, Right

    Widex

    FDA UDI
    Widex A/S·05706069686982·Widex EVOKE E-IM (Light beige ) 110, Right

    Widex

    FDA UDI
    Widex A/S·05706069686999·Widex EVOKE E-IM (Clay brown ) 110, Right

    SCREWDRIVER

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·April 10, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 4, 2011

    TENDRIL DX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·February 28, 2023

    Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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