12 results
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32ms
·
Sources: EU EUDAMED, US FDA
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POST-AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BACTIGEN - N.MENNINIGITIDIS TEST
FDA 510(k)
FDA Class 2
·Microbiology
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 12, 2014
CORDLESS DRIVER 2 HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·November 2, 2012
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FMG·June 15, 2015
TPRLC 133 T1 PPS HO 14X148MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·February 10, 2020
TPRLC 133 MP TYPE1 PPS HO 18.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·February 10, 2020
TPRLC 133 FP TYPE1 PPS HO 5.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·February 10, 2020
TPRLC 133 T1 PPS HO 15X150MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·February 10, 2020
TPRLC 133 T1 PPS HO 14X148MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·February 10, 2020
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