BEUDAMED
    28 results · 34ms · Sources: EU EUDAMED, US FDA

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    SE-601 SERIES ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ThermoCool SF NAV

    FDA UDI
    Biosense Webster Inc·10846835009293·

    D-Fine Double Diamond™ Primary Polisher Refill #03

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001816·Dental burnisher

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131503·MUA NR RP 2.0GH Str

    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·September 6, 2017

    Kirwan (Distributor Gyrus ACMI)

    FDA UDI
    KIRWAN SURGICAL PRODUCTS LLC·00841019108741·Bipolar Adson Forceps Non-Stick Reusable 1mm Ti...

    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0315030·Probe, 1.5 inch Ball, Steffee, Curved, Impaction

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857561045·Parallel Trial Size 9x28x8 mm

    AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DUSIMETRY CHECK

    FDA 510(k)
    FDA Class 2 ·Radiology

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JDS·March 31, 2014

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·April 13, 2015

    ACUSON

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code OBJ·July 26, 2016

    TRILOTY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·May 14, 2013

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 25, 2008

    ACUSON ACUNAV ULTRASOUND CATHETER

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code OBJ·July 27, 2016

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·March 25, 2015

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·October 11, 2013