14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LACTOSORB TIBIAL L-15 SCREW AND WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 29, 2013
STRYKEFLOW2 WITHOUT TIP (6BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GCX·May 10, 2011
BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 27, 2020
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 27, 2020
HEMAGARD KNITTED STRAIGHT
FDA Adverse Event
Injury
·INTERVASCULAR SAS·Product code DSY·October 16, 2023
ENDO CLIP III
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code GDO·April 27, 2018
BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 28, 2020
BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 14, 2020
INTERGARD KNITTED BIFURCATED
FDA Adverse Event
Injury
·INTERVASCULAR SAS·Product code DSY·November 6, 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