BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    HELIX HYDRO-JET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CERASMART®

    FDA UDI
    Gc America Inc.·D0470124641·CERASMART 270 14 Unsvl A3.5 LT 5p

    CERASMART™

    FDA UDI
    Gc America Inc.·14548161320481·CERASMART™ 270 14 Universal A3.5 LT 5p Block

    K012364

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015

    RADCALC, MODEL V.4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMITH & NEPHEW OFF-CENTERED PORP

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code PNY·October 6, 2016

    QUADROX-I NEO. MIT RESERVOIR

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015

    OXYGENATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

    OXYGENRATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

    Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm.

    FDA Enforcement
    Class I ·Terminated·Abbott Vascular·June 7, 2017

    PENTA

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 15, 2013

    CLEARLINK 1.2 MICRON EXTENSIONSET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·March 9, 2011

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC IRELAND, LTD·Product code ESW·March 12, 2008

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 22X15

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 8, 2021

    ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - 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