BEUDAMED
    9 results · 35ms · 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 ×

    UNIVERSAL ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Malecot

    FDA UDI
    COOK INCORPORATED·00827002169241·Silicone Malecot Catheter

    AUTOGENESIS AUTOMATOR, MODEL M1000

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO IQ METER

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 10, 2011

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·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