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

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    TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code LPP·November 27, 2012

    GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code IYN·May 16, 2025

    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

    FDA Recall
    Terminated ·App Pharmaceuticals Llc·Product code NZW·May 20, 2010

    HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

    FDA Recall
    Terminated ·App Pharmaceuticals Llc·Product code NZW·May 20, 2010

    SideWinder Hip Wand Product Number AC2340-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·August 8, 2011

    OPUS SmartStitch Product Number OM-8178 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code KOG·August 8, 2011

    3.0 60 Degree wand Part Number A2530-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011

    OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GAT·August 8, 2011

    5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff repair.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    Saber 30 Part Number A4330-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011

    OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits Intended for rotator cuff repair.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code HWC·August 8, 2011

    3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011

    OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    MultiVac Tristar 50 Product Number AS4630-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011

    OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011

    90 Degree LoPro with Cable Part Number AC1336-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011

    3.5mm 90 Degree Part Number A1335-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011