85 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
FDA Enforcement
Class II
·Ongoing·Sonendo Inc·November 23, 2022
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 Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Company·March 13, 2013
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
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·August 14, 2024
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