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

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    ZYNO MEDICAL ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vitale™

    FDA UDI
    Merit Medical Systems, Inc.·00884450411452·

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018296·Wide Jaw Punch small 15 degree up milled 3.5mm ...

    ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLEXIVA TRACTIP

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

    IN00087 CLERMONT FERRAND PH

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DWF·March 7, 2014

    PERMACOL 10X15 1.5MM

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016

    GOLD PROBE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·May 20, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 10, 2011

    LATERALIZD HUM CUP DIA 36+3MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code KWS·August 14, 2008

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Injury ·ANGIOSCORE, INC·Product code LIT·March 29, 2016

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC·Product code LIT·November 26, 2015

    INSPIRE 6F HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022