11 results
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24ms
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Sources: EU EUDAMED, US FDA
O.R. CONCEPTS' IRRIGATING KITTNER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FIBERFILL AGP
FDA 510(k)
FDA Class 2
·Dental
URSA ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LATERAL STRAIGHT STEM 15.0 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·March 28, 2012
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 22, 2013
PFC SIGMARP STB TB IN 4 15.0
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·December 8, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 9, 2014
SULOX-HD 32 M 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·April 23, 2019
SULOX, HEAD, M¸ 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·August 3, 2018
SULOX-HEAD 28 M 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·April 4, 2019
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012