11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMAGEnet6 Ophthalmic Data System
FDA 510(k)
FDA Class 2
·Radiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111010873·SKLARLITE DRESS FCP SERR 5.5"
INTRATIO2 PT/INR PROFESSIONAL TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 4, 2014
INTRATIO2 PT/INR PROFESSIONAL TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 4, 2014
INTRATIO2 PT/INR PROFESSIONAL TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 4, 2014
ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Surgical Green Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 6, 2014
DEPUY ASR XL FEM IMP SIZE 55
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·August 18, 2011
ECHELON MICRO CATHETER
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code KRA·July 18, 2013
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