17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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cNeuro cMRI
FDA 510(k)
FDA Class 2
·Radiology
SR PIP
FDA UDI
Stryker GmbH·00886385019871·SIZE 4: PIP PROXIMAL BROACH ASSEMBLY (DRK. BLUE)
ENSITE VELOCITY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VISUALASE THERMAL THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 8, 2026
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·July 14, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 14, 2013
UROMAX ULTRA BALLOON CATHETER 10CC KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code EZN·September 17, 2008
DA VINCI SP SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 4, 2025
DA VINCI SP SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 4, 2025
EVEREST ® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·STRYKER-SPINE·Product code LXH·September 9, 2019
DA VINCI SP SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 4, 2025
DA VINCI SP SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 4, 2025
DA VINCI SP SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 4, 2025
DA VINCI SP SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 4, 2025
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
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026