10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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General Cutting Contra Handpiece
FDA 510(k)
FDA Class 1
·Dental
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·November 10, 2021
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·January 15, 2026
Healthweigh
FDA UDI
Rice Lake Weighing Systems, Inc.·00850042373538·Measuring Mat, RL-PMM-20 20-99cm x 5mm Material...
TRIMOTION INJECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART
FDA 510(k)
FDA Class 2
·Orthopedic
WHITESTAR SIGNATURE SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·October 17, 2014
MULTI-LINK RX ZETA CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·July 28, 2011
MIS ROD Ø6 RAD 200 NORMALISED L120 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·June 21, 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