10 results
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19ms
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Sources: EU EUDAMED, US FDA
ALFIS Vitamin D, ALFIS-3 Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038622·
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038639·
VCARE A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·November 3, 2008
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL KALAMAZOO·Product code FNL·July 21, 2011
QUATTRO SUTURE NEEDLE
FDA Adverse Event
Other
·CAYENNE MEDICAL, INC.·Product code NBH·July 9, 2013
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 28, 2024
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