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

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CAPIOX SP PUMP HEAD

FDA 510(k)
FDA Class 2 ·Cardiovascular

I-CHROMA CRP TEST

FDA 510(k)
FDA Class 2 ·Immunology

OTICON I31 INITIALES HEARING AID

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

STOPCOCK MANIFOLD GANGS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2014

GLOBAL AP CTA HUMRL HEAD 48X18

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS·Product code HSD·February 15, 2013

FREESTYLE LITE

FDA Adverse Event
Injury ·Product code NBW·January 18, 2011

TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

FDA Adverse Event
Death ·STRYKER TRAUMA KIEL·Product code HSB·September 29, 2015

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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