10 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Clarity Reveal
FDA 510(k)
FDA Class 2
·Radiology
Spacer-G and Spacer-K
FDA 510(k)
FDA Class 2
·Orthopedic
ASIMANAGER - AT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·AQUATEC OPERATIONS GMBH·Product code FSA·June 14, 2013
X3 TRIATHLON CS INS SIZE4 11MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·July 18, 2011
CONCERTO
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·September 17, 2008
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018