14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CODMAN ETHISORB DURA PATCH
FDA 510(k)
FDA Class 2
·Neurology
Monolith
FDA UDI
Nuvasive, Inc.·00887517677129·Monolith Core, Ø14x13mm
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79914131·Sprint II Bracket McLaugh/Benn/Trev. .018" mand...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199090·AK3 Congruent Insert Trial Size 4, 13mm
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79914130101·Sprint II Bracket McLaugh/Benn/Trev. .018" mand...
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79914131001·Sprint II Bracket McLaugh/Benn/Trev. .018" mand...
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79914130051·Sprint II Bracket McLaugh/Benn/Trev. .018" mand...
AlexLAZR
FDA UDI
Candela Corporation·00817495022598·Pulsed Laser
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPTURE-R READY-SCREEN (I AND II)
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·March 6, 2013
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·February 15, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code NVN·August 8, 2014
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016