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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ELECSYS FOLATE III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331170027·operating scissors, blunt/blunt, curved, 6" (15...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515019270·Jacobson Micro Hemo Fcps,vry del, slght cve, 7 ...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581210·Split Tube Retractor Ø16x80 mm
EUCLID (TM) TIER 1-GW ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CEROS TCP GRANULES
FDA 510(k)
FDA Class 2
·Dental
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 24, 2013
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·June 22, 2011
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·September 3, 2008
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