18 results · 22ms · Sources: EU EUDAMED, 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