8 results · 21ms · Sources: EU EUDAMED, US FDA

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NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TITANIUM SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

(MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 12, 2024

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 6, 2014

LIBERTÉ (TM)

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code MAF·September 2, 2011

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code FSA·July 18, 2013

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