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

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MERIDIAN TITANIUM FEMORAL STEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

artegral

FDA UDI
Merz Dental GmbH·D7091972228·posteriors; shade A3.5 light; size XS; upper jaw

SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)

FDA 510(k)
FDA Class 1 ·General Hospital

pioli IOL Delivery System

FDA 510(k)
FDA Class 1 ·Ophthalmic

VITROS CHEMISTRY PRODUCTS PHBR SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·February 21, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR·Product code DQX·January 24, 2011

ENDOPATH ETS

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·May 8, 1997

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