8 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.

Normatec Go

FDA 510(k)
FDA Class 2 ·Physical Medicine

SINGLE USE MANOMETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

Powder Free Nitrile Examination Gloves, Blue Chemotest

FDA 510(k)
FDA Class 1 ·General Hospital

TRIDENT ALUMINA INSERT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MRA·November 3, 2014

ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·August 24, 2011

RFA GROUNDING PAD

FDA Adverse Event
Malfunction ·COVIDIEN LP·Product code GEI·July 1, 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

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025