12 results
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27ms
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Sources: EU EUDAMED, US FDA
ARM-A-VIAL LV HEATER-BREATHING SYS
FDA 510(k)
FDA Class 2
·Anesthesiology
LF
FDA UDI
Liebel-Flarsheim Company LLC·10746190002710·OptiVantage Dual-Head CT Contrast Delivery Syst...
DD cubeY® HL
FDA UDI
Dental Direkt GmbH·EDDIG8440051·The DD cubeY® HL zirconium dioxide milling blan...
NABI RF-Q.S. TEST
FDA 510(k)
FDA Class 2
·Immunology
SELECTIVE STREPTOCOCCUS AGAR
FDA 510(k)
FDA Class 1
·Microbiology
INJ. OPTIV DH,SI W/OEM
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM·Product code IZQ·December 9, 2024
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 2, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·November 23, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010
INJ. OPTIV DH,SI W/OEM
FDA Adverse Event
Malfunction
·LIEBEL- FLARSHEIM·Product code IZQ·March 20, 2025
INJ. OPTIV DH,SI W/OEM
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM·Product code IZQ·October 21, 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