12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EsFlow PLUS
FDA 510(k)
FDA Class 2
·Dental
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250317030·ceraMotion® Paste 2D Body R / dental ceramic ma...
Rx Knee CR Cemented Symmetrical Femur
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215123017·
STILLE Retractors
FDA UDI
Stille AB·07332339212063·SKIN HOOK KLEINERT-KUTZ STILLE large 7 mm 16 cm...
BURANE XL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 16, 2023
NAVLOCK
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·October 21, 2025
PRECISION SPEEDTAC®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MBI·September 15, 2011
HEARTSTART SLA BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DQA·November 6, 2014
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 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