16 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY·Product code FOZ·March 16, 2026
TRUSIGNAL SPO2 FINGERTIP SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DK50 DS
FDA 510(k)
FDA Class 2
·Anesthesiology
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 6, 2026
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 6, 2026
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 24, 2025
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 29, 2011
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LQC·October 1, 2008
SPRINT QUATTRO SECURE S
FDA Adverse Event
Death
·MPRI·Product code LWS·June 26, 2013
NEURO SPG-1X1"-STERILE- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 20, 2025
NEURO SPNG-1/2X3"-STRL- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 7, 2025
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