945 results
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10ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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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
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
FDA Enforcement
Class II
·Terminated·Staar Surgical Co.·June 22, 2016
ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 18, 2019
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 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
ROTEM ex-tem Canada Part No: 503-05-CA
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 18, 2019
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 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
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·December 31, 2014
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
Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.
FDA Enforcement
Class II
·Terminated·Fisher Scientific Co·August 21, 2013
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.
FDA Enforcement
Class II
·Terminated·Mar-Med Co·February 10, 2021
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·December 25, 2013
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·December 25, 2013
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 31, 2013
ACL TOP (Base); PN 0000280000 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
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
FDA Enforcement
Class II
·Terminated·Staar Surgical Co.·July 24, 2013
ACL TOP 700, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP 300 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
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
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·February 10, 2016
ACL TOP 500 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014