BEUDAMED
    20 results · 25ms · Sources: EU EUDAMED, US FDA

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

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517576118·CoRoent Ant TLIF Ti, 8x13x40mm 0°

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304270978·

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704513523·

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304472747·

    FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP

    FDA 510(k)
    FDA Class 2 ·Neurology

    CUSTOM COMFORT NIGHTGUARD

    FDA 510(k)
    FDA Unclassified ·Unknown

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 28, 2021

    POLISHED FINNED TIB TRAY 79MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRO·March 28, 2019

    UNKNOWN COOLSCULPTING SYSTEM

    FDA Adverse Event
    Injury ·ALLERGAN PLEASANTON·Product code OOK·June 29, 2021

    VNGD CR INTLK FEMORAL 55MM RT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018

    VANGUARD CR ILOK FEM-LT 57.5

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

    TOTAL ASR FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 21, 2013

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 28, 2011

    UNKNKOWN FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 3, 2020

    VNGD CR INTLK FEMORAL 55MM RT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 9, 2020

    BIOMET ILOK PRI TIB TRAY 59MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 2, 2020

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017