10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RealStar® ASR EBV Probe
FDA UDI
altona Diagnostics GmbH·04250453100857·Epstein-Barr virus (EBV) DNA specific probe (FA...
RealStar® ASR EBV Primer
FDA UDI
altona Diagnostics GmbH·04250453100840·Epstein-Barr virus (EBV) DNA specific primer
EBI XFIX OPTIROM KNEE FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
BILLY BOY MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014
JUVEDERM ULTRA PLUS XC TSK US
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·May 23, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·June 16, 2011
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