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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mi-eye 3 needlescope with cannula, mi-tablet 3
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Bernafon AG·05711584114568·CO1 B 105, 2.4G NFM MAC CAPTO 1 GPL
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327499834·LOCKING PLATE, SAGITTAL SPLIT, LONG BAR
REPROCESSED GUIDEWIRES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
AQUAMANTYS 6.0 BIPOLAR SEALER
FDA Adverse Event
Injury
·SALIENT SURGICAL TECHNOLOGIES, INC.·Product code GEI·October 27, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 16, 2011
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 9, 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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025