18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bladder Scanner, Model Name:M5
FDA 510(k)
FDA Class 2
·Radiology
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
FDA 510(k)
FDA Class 2
·Neurology
JAZZY ELITE 6
FDA 510(k)
FDA Class 2
·Physical Medicine
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 25, 2014
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·July 9, 2013
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·March 25, 2026
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 12, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024
BD ULTRA-FINE¿ MINI PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 5, 2022
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