BEUDAMED
    13 results · 26ms · 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.

    BILI BLUE F20T12/BBY AND F40T12/BBY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189442·Apex Revision Knee System - Revision Tibia Tray...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065630·INTRAORAL ELASTICS 2,5 oz 1/8" brown

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027643·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189435·Apex Revision Knee System - Revision Tibia Tria...

    E3 MICROPROB SERIES OF LASERS AND ACCESSORIES

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

    ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION

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

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    ELLIPSE VR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

    MECHANICAL CHAIR/TRANSPORT CHAIR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·September 15, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN BENNETT CORP.·Product code CBK·April 11, 2011

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020