BEUDAMED
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    LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033404·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm

    SUPRASPERM SYSTEM

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

    C. DIFFICILE TOX A/B II

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 7, 2025

    VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER

    FDA Adverse Event
    Injury ·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·April 3, 2013

    BARD PELVICOL ACCELULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code FTL·March 24, 2011

    ETHICON PDS 11 Z346 SUTURE

    FDA Adverse Event
    Injury ·ETHICON·Product code GAN·April 22, 2008

    Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·December 29, 2003

    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