BEUDAMED
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    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·December 21, 2020

    SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.

    FDA Recall
    Open, Classified ·Synthes (USA) Products LLC·Product code JDR·September 27, 2022

    FUSO Analyzer 300F Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·September 20, 2010

    i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CGA·September 20, 2010

    Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·September 20, 2010

    i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·September 20, 2010

    Military Kit Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CGA·September 20, 2010

    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·September 20, 2010

    02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.621S, 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·October 27, 2010

    02.122.586S, 85mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.585, 85mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010