BEUDAMED
    509 results · 19ms · Sources: EU EUDAMED, US FDA

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    Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DTM·November 14, 2019

    BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code NVI·November 13, 2007

    ORCHESTRA/ORCHESTRA PLUS Programmer

    FDA Recall
    Terminated ·Sorin Group Italia S.r.l. Via Crescentino Saluggia, VC Italy·Product code LNX·November 20, 2013

    SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code CAC·November 27, 2018

    RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code CAC·November 27, 2018

    COULTER LH 700 Series Hematology Analyzers

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·November 8, 2002

    COULTER LH 700 Series Hematology Analyzers

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·November 8, 2002

    COULTER LH 700 Series Hematology Analyzers

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·November 8, 2002

    COULTER LH 700 Series Hematology Analyzers

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·November 8, 2002

    CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135 C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·November 10, 2020

    CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code OHA·November 10, 2020

    Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MMI·April 13, 2010

    Cytomics FC500 with CXP Software

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JJF·November 23, 2005

    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HRS·November 1, 2021

    smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HRS·November 1, 2021

    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HRS·November 1, 2021

    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HRS·November 1, 2021

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020.

    FDA Recall
    Terminated ·AngioScore Inc.·Product code DQY·November 16, 2010

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020.

    FDA Recall
    Terminated ·AngioScore Inc.·Product code DQY·November 16, 2010

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020.

    FDA Recall
    Terminated ·AngioScore Inc.·Product code DQY·November 16, 2010