12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bead Block
FDA 510(k)
FDA Class 2
·Cardiovascular
AGXO
FDA UDI
Oticon A/S·05707131282408·H160V2 TI, BTE 13 WL 85 DBL AGXO
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·April 23, 2024
AESCULAP MONOMAX ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
FDA 510(k)
FDA Class 2
·General Hospital
OPTICROSS 6 HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 6, 2024
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·October 8, 2014
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 6, 2011
MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019
MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019
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