34 results
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6ms
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Sources: EU EUDAMED, US FDA
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
FDA Enforcement
Class II
·Terminated·Stanmore Implants Worldwide Ltd.·September 13, 2017
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
FDA Enforcement
Class II
·Terminated·Clinical Innovations, LLC·February 4, 2015
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Enforcement
Class II
·Terminated·Clinical Innovations, LLC·October 21, 2015
StemPro¿ MSC SFM CTS"
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·November 13, 2019
ACL TOP 300 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP 500 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP 700 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·December 24, 2014
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·July 2, 2014
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·July 12, 2017
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 20, 2013
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016
GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
FDA Enforcement
Class II
·Terminated·Life Technologies, Corp.·August 1, 2018
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
FDA Enforcement
Class II
·Terminated·Cook Medical Llc·January 20, 2021
ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 25, 2013
ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 25, 2013
ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 25, 2013
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012