BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    FORA COMFORTSCAN EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139243684·UNITY KNEE™ PS-C INSERT - Size 7 x 12mm

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154280940·BONE SCREW,CROSS-PIN,MP,SELF-TAPPING

    Headless Compression Screw

    FDA UDI
    I.T.S. GmbH·09120047300152·Headless Compression Screw, Cannulated, D=2.0mm...

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037313053·STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +12

    32mm Glenosphere and Humeral Cup

    FDA UDI
    FX SOLUTIONS·03701037313909·STANDARD TRIAL HUMERAL CUP CUSTOM MADE 135/145°...

    RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE

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

    ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·January 15, 2013

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·May 6, 2013

    PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INCORPORATED·Product code HSB·September 30, 2013

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·June 5, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

    PFC PLI 15MM S6

    FDA Adverse Event
    Injury ·DEPUY RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC·Product code JWH·August 14, 2008

    VALVE HANCOCK II

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·September 23, 2016

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 15, 2013

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018