BEUDAMED
    20 results · 13ms · Sources: EU EUDAMED, US FDA

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    Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

    FDA Recall
    Terminated ·Datascope Corp·Product code DRT·August 19, 2005

    CryoValve, Aortic Valve & Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·December 17, 2004

    CryoValve, Pulmonary Valve and Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·December 17, 2004

    Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BTO·April 19, 2005

    CryoValve, Aortic Valve & Conduit SG

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·December 17, 2004

    PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.

    FDA Recall
    Terminated ·Boston Scientific Scimed·Product code DXZ·April 19, 2005

    CR DX-S, DX-S, Computed radiography system (Digitizer)

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·November 3, 2005

    COULTER LH 700 Series Hematology Analyzer, PN 6605632 and 6605632R

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·December 15, 2005

    COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKJ·December 15, 2005

    ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code JPA·May 19, 2005

    VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LCD·July 19, 2005

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 19, 2005

    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763 and 801763 (Japan unit).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 19, 2005

    Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesville, FL 32653***. ''

    FDA Recall
    Terminated ·Exactech, Inc.·Product code JWH·December 19, 2005

    SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA 98021 Each kit is packaged in a hermetically sealed clear plastic pouch with white backing. Product is labeled as Sterile. 24 pouches are packaged in a white cardboard box and labeled as SonoSite L25 Needle Guide Kit, 21 GAUGE REF# P04053-01, Quantity: 24, CONTENTS STERILE IF PACKAGE IS INTACT. Mfg for: Sonosite, Inc. 888/482-9449*425/951-1200, Bothell, WA 98021 USA. www.sonosite.com

    FDA Recall
    Terminated ·Sonosite, Inc.·Product code ITX·December 12, 2005

    Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics Corp., 325 Corporate Drive; Mahwah, NJ 07430 Authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan Cedex, France

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HTO·April 15, 2005

    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·September 19, 2005

    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·September 19, 2005

    AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

    FDA Enforcement
    Class I ·Terminated·Stryker Sustainability Solutions·July 27, 2016

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018