BEUDAMED
    18 results · 29ms · 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.

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0100610·Caddie Lid, Modular Bone Screws

    DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atos Medical

    FDA UDI
    ATOS MEDICAL INC.·00817126020832·2010-061 Laryngectomy Pulmonary Kit with Standa...

    NIHON SEIMITSU SOKKI CO., LTD.

    FDA registration
    NIHON SEIMITSU SOKKI CO., LTD.·4 products·🇯🇵 Japan

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521010061D0·10 x 60 mm SI Implant with HA Coating

    System, Non-Coherent Light, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·CURELIGHT BROADBAND (MODEL CURELIGHT 01)

    MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    LIVESURE THC SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·July 29, 2008

    AGILTRAC .018 PERIPHERAL DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·June 26, 2008

    IV SET SN404 W/O BP Y-CONN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·December 4, 2020

    POLY-TAPE, 20 X 500MM

    FDA Adverse Event
    Injury ·XIROS·Product code JDR·December 6, 2011

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 11, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013