BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103230·BRACKET LEWIS 022 4.5MM TQ=0 A=0 R=0 PROFILE=HP...

    HELIODENT VARIO

    FDA 510(k)
    FDA Class 2 ·Dental

    POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·February 13, 2013

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·February 9, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·February 26, 2008

    Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

    FDA Recall
    Terminated ·Alltech Medical Systems America Inc·Product code LNH·January 9, 2015

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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