8 results · 19ms · Sources: EU EUDAMED, US FDA

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MOXALACTAM

FDA 510(k)
FDA Class 2 ·Microbiology

SHARPS CADDY MAGNETIC & SHARPS CADDY FOA

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

VIVIX-S WITH VXVUE

FDA 510(k)
FDA Class 2 ·Radiology

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 2, 2023

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·February 5, 2014

SHORT DRIVER RMAS

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·November 7, 2012

UNKNOWN SUTURE PRODUCT

FDA Adverse Event
Injury ·ETHICON, INC.·Product code GAN·August 30, 2010

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