BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180507803·TL2/IDENTITI FIXATION PIN – WIDE, SHORT

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180507797·TL2/IDENTITI FIXATION PIN – NARROW, SHORT

    ANATOMICAL PRESS-FIT HUMERAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRASAFE DENTAL INJECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 10, 2011

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HWM·July 25, 2008

    SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 42-15

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·June 26, 2018

    SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 50-21

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·June 11, 2018

    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