10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Flexible Fixation Device for Gynecological Applicators (GM11001960)
FDA 510(k)
FDA Class 2
·Radiology
Oticon
FDA UDI
Sbo Hearing A/S·05714464058273·OTICON ZIRCON 2 MINIRITE T C090 DEMO
Safecare Vinyl Exam Gloves
FDA UDI
ARISE MEDICAL LLC·00372217036081·Safecare Vinyl Exam Gloves - M- 100 Ct
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017989·K-Wire, Single Ended, Trocar Point, Diameter Si...
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
FDA 510(k)
FDA Class 2
·Physical Medicine
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VICTORY XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·September 9, 2011
CHUCK DRILLING SPEED W/KEY CLAMPING RANG
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·November 10, 2014
2.15MM X 22MM SPIRAL ROUTER
FDA Adverse Event
Malfunction
·DEPUY SNTHES POWER TOOLS·Product code HBC·July 17, 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