BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    PORTABLE BREAST COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 1 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054915·Strip Crown Forms

    SCANLAN® Titanium Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003673·S LEG Pus Mic fcp, RH NS DG, 1x2 t, curved 0.5m...

    ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEART 2005

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 24, 2014

    MINMED QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 16, 2025

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·May 6, 2010

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·November 5, 2010

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·November 25, 2010

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDQ·March 14, 2013

    UNKNOWN ZIMMER CR FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 24, 2011

    ELITE PASS SHUTTLE NEEDLE, BOX OF 5

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code FMI·February 22, 2008

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. 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. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide 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, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016