9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
FDA 510(k)
FDA Class 2
·Physical Medicine
HEALIX ADVANCE PEEK ANCHOR w/PERMATAPE PERMACORD
FDA UDI
Medos International Sàrl·10886705027842·PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE...
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
FDA 510(k)
FDA Class 2
·Neurology
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 5, 2008
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·June 24, 2011
MITEK VAPR COOL PULSE 90 ELECTRODE, W/HAND CONTROLS
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code GEI·July 12, 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