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

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    Codman Certas Plus Programmable Valve

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124122·Modular Offset Stem 11mm x 150mm x 2mm

    Simpact

    FDA UDI
    Life Spine, Inc.·00190837079666·90 degree Cup Curette, Right #2, 10mm Tip

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071521521C0·Custom Revision Curette 21.5" Size 2

    B-BOP PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COBAS INTEGRA 400

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 17, 2009

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·January 13, 2025

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 20, 2017

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·August 1, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·July 25, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 17, 2017

    VITROS 250 CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·March 12, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·March 21, 2017

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 7, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 24, 2015

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 26, 2017

    MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019