BEUDAMED
    48 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·September 24, 2014

    BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019

    BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019

    RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·May 4, 2016

    BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019

    BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019

    BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019

    BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019

    BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019

    CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·January 13, 2021

    RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·December 24, 2014

    RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·December 24, 2014

    RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·December 24, 2014

    BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 3, 2013

    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blood/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·September 29, 2021

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014

    Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·August 8, 2012