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

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    SPECTRA MRSA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AutoPulse®Resuscitation System

    FDA UDI
    Zoll Circulation, Inc.·00849111000710·The AutoPulse System consists of 4 primary comp...

    PREG-Q EARLY PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SILCONE COATED I/A 45 HANDHELD INSTRUMENT

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·May 7, 2019

    AutoPulse®Resuscitation System

    FDA UDI
    Zoll Circulation, Inc.·00849111000970·The AutoPulse System consists of 4 primary comp...

    OLYMPUS ESG-100, 100...120 V~,

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·April 6, 2013

    SM204 M-SERIES W/ BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 21, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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