772 results
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42ms
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Sources: EU EUDAMED, US FDA
USA SCIENTIFIC, INC.
FDA registration
USA SCIENTIFIC, INC.·1 product·🇺🇸 United States
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FDA UDI
Usa Scientific, Inc.·00850064227048·Layer4 Comfort Nitrile Exam Gloves Medium 200 p...
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FDA UDI
Usa Scientific, Inc.·00850064227062·Layer4 Comfort Nitrile Exam Gloves Large 200 pe...
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FDA UDI
Usa Scientific, Inc.·00850064227024·Layer4 Comfort Nitrile Exam Gloves Small 200 pe...
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FDA UDI
Usa Scientific, Inc.·00850064227017·Layer4 Comfort Nitrile Exam Gloves X-Small 200 ...
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FDA UDI
Usa Scientific, Inc.·00850064227123·Layer4 RapidDon Nitrile Exam Gloves Small 250 p...
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FDA UDI
Usa Scientific, Inc.·00850064227185·Layer4 RapidDon Nitrile Exam Gloves X-Large 230...
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FDA UDI
Usa Scientific, Inc.·00850064227086·Layer4 Comfort Nitrile Exam Gloves X-Large 200 ...
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FDA UDI
Usa Scientific, Inc.·00850064227109·Layer4 RapidDon Nitrile Exam Gloves X-Small 250...
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FDA UDI
Usa Scientific, Inc.·00850064227161·Layer4 RapidDon Nitrile Exam Gloves Large 250 p...
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FDA UDI
Usa Scientific, Inc.·00850064227147·Layer4 RapidDon Nitrile Exam Gloves Medium 250 ...
Scientific Analytics/DARI Motion, Overland Park, KS USA
FDA registration
Scientific Analytics/DARI Motion, Overland Park, KS USA·1 product·🇺🇸 United States
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
FDA Enforcement
Class II
·Terminated·Fisher Diagnostics·August 2, 2017
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
FDA Enforcement
Class II
·Terminated·Fisher Diagnostics·August 2, 2017
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013
SPIDER FX
FDA Adverse Event
Injury
·COVIDIEN·Product code NTE·September 19, 2022
ZILVER VENA VENOUS SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code QAN·May 21, 2024
ZILVER VENA VENOUS SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code QAN·May 27, 2024
ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIO·July 27, 2022