BEUDAMED
    13 results · 21ms · 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 ×

    CAP PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WN Positioning Cylinder for Solid Abutment 033020

    FDA UDI
    BIO CONCEPT Co., Ltd.·06947600302308·

    AF811

    FDA UDI
    Respironics, Inc.·00606959007666·AF811 Mask, with Standard Elbow, with Headgear,...

    Life Support Products

    FDA UDI
    Allied Medical, LLC·00026072000465·Demand Valve

    Klitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0603500·Tray, Base, 3.5"

    CRYOSURGICAL UNIT AND ACCESSORIES

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

    THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    RGX 3 PEG SER A PATELLA 31MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRY·August 16, 2018

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code LWR·April 17, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 21, 2011

    OUTBACK RE-ENTRY CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQY·June 19, 2008

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015