10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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