14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
FDA 510(k)
FDA Class 2
·Hematology
OptoWire III
FDA 510(k)
FDA Class 2
·Cardiovascular
NOBELPROCERA IMPLANT BRIDGE ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 7, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·April 27, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·April 16, 2018
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 24, 2014
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 5, 2010
ENDURANT II ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·December 31, 2012
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 5, 2018
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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