BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033411·Baltic Denture System BDLoad BDLoad ↓ Sw7 PLSEu...

    Brasseler USA

    FDA UDI
    Provision·B504OMKM334110·

    Brasseler USA

    FDA UDI
    Provision·00810041064967·

    NA

    FDA UDI
    STERILMED, INC.·10888551017138·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm

    ELECSYS TESTOSTERONE CALSET II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PULPDENT CAVITY PREPARATION IV

    FDA 510(k)
    FDA Class 2 ·Dental

    RUNWAY GUIDE CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013

    SD/PD MEDIUM CURVED

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·April 3, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 23, 2011

    MITY VAC II

    FDA Adverse Event
    Injury ·Product code HDB·April 22, 2008

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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