9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
KING Snap Lead/DIN Connector
FDA UDI
Kego Corporation·00663427000093·KING Snap Lead/DIN Connector Qty 5
2.4 m (96")...
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·June 20, 2019
POWERLIPO LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
FDA 510(k)
FDA Class 1
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code OUT·June 21, 2013
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·June 23, 2011
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