11 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 6, 2013
Fuse 1C Colonoscope
FDA Recall
Terminated
·EndoChoice, Inc.
11810 Wills Rd Ste 100
ATTN: Theron Gober
Alpharetta GA 30009-2081·Product code FDF·December 18, 2015
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
FDA Enforcement
Class II
·Terminated·Vygon Corporation·March 20, 2013
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
FDA Recall
Terminated
·In2Bones, SAS 28 Chemin Du Petit Bois Ecully France·Product code HWC·March 9, 2015
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
FDA Recall
Terminated
·In2Bones, SAS 28 Chemin Du Petit Bois Ecully France·Product code HWC·March 9, 2015
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
FDA Enforcement
Class III
·Terminated·ELITech Clinical Systems SAS·October 8, 2014
MAKOplasty Hip Array Kit Laminate 150230
FDA Recall
Terminated
·Mako Surgical Corporation·Product code OLO·November 25, 2015
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
FDA Recall
Terminated
·MRP, LLC dba AMUSA·Product code NGT·February 9, 2015
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
FDA Recall
Terminated
·Cook Inc.·Product code DQO·October 7, 2015
PANTERA Proximal Humerus Fracture Plate System
FDA Enforcement
Class II
·Terminated·Toby Orthopaedics, Inc.·December 11, 2019
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 Rover Ultra (230V) 0702-002-000ES, Neptune 2 Rover (230V) Spanish 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish 0702-002-000IT, Neptune 2 Rover (230V) Italian 0702-002-000R, Repair Neptune 2 Rover Ultra (230V) Product Usage: The Neptune 2 Waste Management System is intended to be used in the operating room, pathology, surgical centers, and doctor s offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electro cautery or laser devices. Contraindication: connection of the Neptune 2 Waste Management System directly to chest tubes or other closed wound drains. The Stryker Neptune 2 Rover is a mobile unit used to suction, collect fluid waste, and evacuate surgical smoke from a surgical site during operation. Fluid waste is removed from the surgical site through suction tubing connected to inlet ports of disposable manifolds installed in the rover. The Diverter Valve Assembly consists of two diverter valves with three hoses, one inlet and two outlets. The sole purpose of the Diverter Valve Assembly is to direct/divert water from the fresh water inlet to either the large canister or small canister via the pre-fill tank.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JCX·May 22, 2015