15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOTUBE TUBE TO RING CLAMP
FDA 510(k)
FDA Class 2
·Orthopedic
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799004000·
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799001429·
EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·June 21, 2023
TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COOLTOUCH, MODEL CTEV
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·July 7, 2015
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 5, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
PLUM LC OL CNVRTBL P
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 27, 2010
PFC SIGMARP STB TB IN 3 10.0
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 12196·Product code NJL·February 14, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·July 28, 2014
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 26, 2023
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