12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Clear Image Aligners
FDA 510(k)
FDA Class 2
·Dental
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304673939·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304648012·
VERIFY 275F GRAVITY INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·March 24, 2026
FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W
FDA Adverse Event
Death
·FUJIFILM CORPORATION·Product code FDA·January 26, 2024
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
COULTER 5C CELL CONTROL
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JPK·July 8, 2011
BEND-SCR F/UNILOCK-RECOPL TI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 22, 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