9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
FDA 510(k)
FDA Class 1
·Physical Medicine
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044510001·Dowel Pin 15 mm
3701 P37,1TO1,90 DEG BED END,STKR
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828146197·3701 P37,1TO1,90 DEG BED END,STKR
ULTRA-FREE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATMOS C361/C451 SUCTION PUMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEU_INS_STIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·March 5, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MINN·Product code NJE·August 7, 2014
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