BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Tornier Latitude

    FDA UDI
    TORNIER, INC.·00846832015528·STRAIGHT REAMER, HUDSON END

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496030393·WONDER MODEL MAMAN 140 SHEER, SIZE M, BRONZE, G...

    MAXILLARY DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    NOVA CORDLESS CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    REBOUND HRD

    FDA Adverse Event
    Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

    ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 29, 2018

    LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    UNKNOWN DEPUY ACETABULAR CUP

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 2, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 7, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·April 16, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    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