17 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CORSCREEN
FDA 510(k)
FDA Class 2
·Cardiovascular
DFS
FDA UDI
Covidien LP·10884521080744·Fascia Stapler
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306814617·Foerster Sponge Forceps, Curved, Serrated, 18cm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106140·Trial, 26 x 14mm, 8 Degree, Tapered, Straight
LifeBand® Load-distributing Band
FDA UDI
Zoll Circulation, Inc.·10849111002247·Single-use chest compression band. (3 per pack...
IRRIGATING CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3I DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·March 14, 2008
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·April 11, 2008
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·June 2, 2008
INTRA
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·April 11, 2008
CARTRIDGE
FDA Adverse Event
Injury
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·May 20, 2008
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·April 14, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 22, 2013
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·July 1, 2008
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