8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
FDA 510(k)
FDA Class 2
·Hematology
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295245032·P.F.C. SIGMA STABILIZED PLUS TIBIAL INSERT TRIA...
OsteoVation Impact
FDA 510(k)
FDA Class 2
·Neurology
MASTALEX -MRSA, MODEL RST501
FDA 510(k)
FDA Class 2
·Microbiology
6.5CM ADULT CRANI ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 13, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·January 13, 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