10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Tula Tympanostomy Tube Delivery Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252436050·ceraMotion® P+PMe Ingot B1, 5 x 2 g / dental ce...
Suntanning Lamps
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
FDA 510(k)
FDA Class 2
·Cardiovascular
IMP,TSV,MCOL MG,4.1MM,10MM,MTX
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 20, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 14, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011
APPLIED MEDICAL
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·July 23, 2013
SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 18, 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