10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
3DXR
FDA 510(k)
FDA Class 2
·Radiology
Symmetry Beckman-Adson
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482061480·Symmetry® Retractor, Beckman-Adson Laminectomy,...
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962160855·BECKMANN ADSON LAMINECTOMY RETRACTOR, 12 1/8", ...
Accu-Chek FlexLink Plus infusion set
FDA 510(k)
FDA Class 2
·General Hospital
EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 23, 2024
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 11, 2014
TRUFILL DCS ORBIT MINI COMPLEX FILL
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·September 12, 2011
TITANIUM HEXALOBE SET SCREW, 8.5MM
FDA Adverse Event
Malfunction
·ALPHATEC SPINE INC·Product code KWP·July 23, 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