BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    BREAST PUMP

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540730800·PEEK CUSTOMIZED CRANIOFACIAL IMPLANT KIT

    KT-10100/EE

    Device
    EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

    Ti-Fix OLIF Spacer

    FDA UDI
    Tyber Medical, LLC·M695P28101000·Ti-Fix OLIF Spacer 28 x 10 x 10 (mm) x 0 °

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0101000·Caddie, Modular Heads, Polyaxial

    Safecheck Gusseted Sterilization Reel(KR10100)

    Device
    EU MDR · Eu Md Class 1 ·Medster Tıbbi Cihaz ve Sağlık Hizmetleri Ltd. Şti.·On the market

    Safecheck Gusseted Sterilization Reel(KR10100-70)

    Device
    EU MDR · Eu Md Class 1 ·Medster Tıbbi Cihaz ve Sağlık Hizmetleri Ltd. Şti.·On the market

    Savecheck Gusseted Sterilization Reel(KR10100-3)

    Device
    EU MDR · Eu Md Class 1 ·Medster Tıbbi Cihaz ve Sağlık Hizmetleri Ltd. Şti.·On the market

    MRIaudio PREM System

    FDA 510(k)
    FDA Class 2 ·Radiology

    AVON PATELLO-FEMORAL JOINT PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Safecheck Gusseted Sterilization Reel(KR10100-70-3)

    Device
    EU MDR · Eu Md Class 1 ·Medster Tıbbi Cihaz ve Sağlık Hizmetleri Ltd. Şti.·On the market

    NEXGEN COMPLETE KNEE SOLUTION, TM STANDARD PRIMARY PATELLA

    FDA Adverse Event
    Injury ·ZIMMER TMT·Product code MBH·June 3, 2018

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014

    ULTRA-THIN¿ DIAMOND¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·October 31, 2012

    PUMP MMT-712RNAB PRDGM INS BL EN US RC

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 16, 2010

    LACTOSORB SYSTEM 14 MM RAPID FLAP

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·December 12, 2018

    Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·May 16, 2018

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017