BEUDAMED
    13 results · 36ms · Sources: EU EUDAMED, US FDA

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    FLUID FILLED TEETHER

    FDA 510(k)
    FDA Class 2 ·Dental

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A082824150·8mm H x 28mm W x 24mm L x 15 Degree ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A082824120·8mm H x 28mm W x 24mm L x 12 degree Lordosis AL...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A08282480·8mm H x 28mm W x 24mm L x 8 Degree ALIF

    ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MACS MODULAR ANTERIOR CONSTRUCT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NONE - SEE PHYSICIAN COMMENTS IN H10.

    FDA Adverse Event
    Injury ·Product code JWH·October 16, 2013

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 28, 2011

    CONTOUR TEST STRIPS (20)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·July 24, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018