10 results · 20ms · Sources: EU EUDAMED, US FDA

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TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

PRESTIGE® LP Cervical Disc System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994490469·TRIAL 6973226 IMPLANT

CardiMax Electrocardiograph

FDA 510(k)
FDA Class 2 ·Cardiovascular

CINCH KNOTLESS FIXATION IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TRIAGE PROFILER SOB PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·June 27, 2019

BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
MEDEL S.P.A.·Product code BTI·February 21, 2013

CE INFUSOR, LV 5 ML/H,12 PACK

FDA Adverse Event
Malfunction ·Product code MEB·January 28, 2011

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
KENSTONE METAL·Product code ITJ·August 1, 2014

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