14 results · 23ms · Sources: EU EUDAMED, US FDA

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ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

DD cubeY® HL

FDA UDI
Dental Direkt GmbH·EDDIG8440031·The DD cubeY® HL zirconium dioxide milling blan...

SPINNING SPIROS

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FPA·November 2, 2016

MOTILITY INDOLE ORNITHINE-MEDIUM

FDA 510(k)
FDA Class 1 ·Microbiology

Electrically powered wheelchair

FDA 510(k)
FDA Class 2 ·Physical Medicine

SPINNING SPIROS

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FPA·November 2, 2016

SPINNING SPIROS

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FPA·November 2, 2016

INJECTOR, OPTIVANTAGE DH W/RFID

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM·Product code IZQ·November 4, 2022

SPINNING SPIROS

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FPA·November 2, 2016

TAXUS® LIBERTÉ®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 2, 2014

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·November 23, 2012

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010

INJECTOR, OPTIVANTAGE DH W/RFID

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM·Product code IZQ·October 27, 2023

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