8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TDK MEDICAL GRADE CD-R
FDA 510(k)
FDA Class 1
·Radiology
IPS INLINE POM SYSTEM
FDA 510(k)
FDA Class 2
·Dental
FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers
FDA 510(k)
FDA Class 2
·Orthopedic
DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS DMC GMBH·Product code MQB·August 9, 2024
12/14 ARTICUL 40MM M SPEC+8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·February 21, 2013
CURVED CIRCULAR STAPLER 25 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 27, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 31, 2014
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