12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025
NA
FDA UDI
Synthes GmbH·10886982153739·4.5MM CORTEX SCREW 95MM
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114314·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1211-1 S...
Playboy Premium Silicone Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Port Access System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 8, 2019
3M ESPE LAVA CHAIRSIDE ORAL SCANNER C.O.S.
FDA Adverse Event
Other
·3M ESPE DENTAL PRODUCTS·Product code NOF·July 20, 2011
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·August 6, 2014
X-ALT HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code LPH·July 3, 2013
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