BEUDAMED
    9 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    PRAGER SHELL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHELHIGH NO-REACT BIOCUFF

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FLUOROLAB PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    EGIA ULTRA UNIVERSAL STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·April 22, 2013

    MBT CEM KEEL TIB TRAY SZ4

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)·Product code NJL·May 3, 2011

    TWINFIX 6.5 AB PRLD STR ANCHOR W/ 2 NDLS

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC. ENDOSCOPY DIV.·Product code MBI·July 25, 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

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022