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

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    LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL

    FDA 510(k)
    FDA Class 2 ·Neurology

    CERASMART™

    FDA UDI
    Gc America Inc.·14548161320474·CERASMART™ 270 14 Universal A3 LT 5p Block

    CERASMART®

    FDA UDI
    Gc America Inc.·D0470124631·CERASMART 270 14 Unsvl A3 LT 5p

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10887488355276·KIT, IV START

    DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STELLAR

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

    IPC® STYLUS TRANSNASAL BUR

    FDA Adverse Event
    Death ·MEDTRONIC XOMED INC.·Product code ERL·February 4, 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

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 12, 2019

    EON MINI

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

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·March 9, 2011

    NELLCOR N-395 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code DQA·March 11, 2008

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

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

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019