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

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    PROBEAT-CR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772344093·PROTECT.PRO ACTION BACK SUPPORT BLACK S

    10M - Southwest Gas Corp

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp

    24M - Southwest Gas Corp

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588010441·24M - Southwest Gas Corp

    THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Trilogy® Trabecular Metal™

    FDA UDI
    Zimmer, Inc.·00889024118454·

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·August 8, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 1, 2011

    PRESIDIO 10 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·October 27, 2014

    AMK STD INS HYLAMER M SZ2 10MM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 2, 2013

    ECHOBRUSH ENDOSCOPIC ULTRASOUND CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FDX·March 4, 2015

    ECHOBRUSH ENDOSCOPIC ULTRASOUND CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FDX·March 4, 2015

    ZIMMER SKIN GRAFT MESHER

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FZW·August 21, 2019

    ECHOBRUSH ENDOSCOPIC ULTRASOUND CYTOLOGY BRUSH

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FDX·March 4, 2015

    JVAC UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code JOL·March 1, 2018

    BLAKE DRAIN UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GBX·March 1, 2018

    Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016