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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033569764·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033569771·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033569740·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033569795·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033569733·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033569719·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033569788·

    ADVIA® Chemistry Reagent Probe Wash 2

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414210070·Reagent Probe Wash 2 - ADVIA Chem. - CONS - 5x2...

    MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VCF PERSONAL LUBRICANT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EXCOR BLOOD PUMP PU VALVES 25 ML, IN/OUT 9 MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·June 16, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 13, 2008

    BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·July 11, 2018

    PTCA CATHETERS

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC·Product code LOX·June 30, 2004

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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