11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Physical Medicine
SR PIP
FDA UDI
Stryker GmbH·00886385019932·SIZE 5: PIP DISTAL BROACH ASSEMBLY (RED)
JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
FDA 510(k)
FDA Class 2
·Cardiovascular
DEPUY CAS HEMI ASR HIP INSTRUMENTS
FDA 510(k)
FDA Class 2
·Neurology
TRIDENT 0 DEG INSERT 40MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·July 15, 2011
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·June 14, 2013
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 17, 2008
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 24, 2022
3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 22MM
FDA Adverse Event
Malfunction
·ORTHOPEDIATRICS, INC·Product code HWC·March 20, 2020
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 24, 2022
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