10 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FDR Visionary Suite
FDA 510(k)
FDA Class 2
·Radiology
SHOULDER NAIL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
PRESSURIZED INFUSION PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
TRACHEOSTOMY TUBES -AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code JOH·October 2, 2014
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·July 7, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 7, 2013
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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