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.

SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

ACACIA PISTON SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

PATIENT EXAMINATION GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

RENEW RECEIVER KIT, 16-CHANNEL

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·February 4, 2015

LIFESTENT VASCULAR STENT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code NIP·March 1, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2011

SPRINT QUATTRO SECURE S

FDA Adverse Event
Injury ·MPRI·Product code LWS·August 8, 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