16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Relizorb
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Aquila Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125851·
Pinehurst Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215030797·
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP
FDA 510(k)
FDA Class 2
·Immunology
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
STEM EXTENSION
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·March 29, 2023
STEMMED NONAUGMENTABLE TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·June 9, 2023
LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2022
LIFESTYLES SKYN LARGE
FDA Adverse Event
Other
·SURETEX LTD.·Product code HIS·May 9, 2013
LIBERTÉ (TM)
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code MAF·July 15, 2011
LINOX SD 65/16
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.,·Product code LWS·September 12, 2008
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 4, 2023
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016
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