9 results · 18ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CONSENSUS 22MM COCRMO FEMORAL HEAD

FDA 510(k)
FDA Class 2 ·Orthopedic

N/A

FDA UDI
MEDTRONIC NAVIGATION, INC.·00673978088846·INST 960-339 EGG QUICK CONNECT HANDLE

Cardinal Health Isolation Gown

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY

FDA 510(k)
FDA Class 2 ·General Hospital

INST 960-339 EGG QUICK CONNECT HANDLE

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·September 13, 2016

ALLEGRETTO WAVE EYE-Q

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code LZS·February 8, 2013

2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·December 16, 2010

NATURA 2 PC - STOMAHESIVE WAFER W/FLEX COLLAR

FDA Adverse Event
Injury ·CONVATEC INC·Product code EXE·July 17, 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