10 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lung Vision System
FDA 510(k)
FDA Class 2
·Radiology
NEXTGEN ALTIUS OCT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
FDA 510(k)
FDA Class 2
·Immunology
TOTAL KNEE REPLACEMENT CEMENT KLASSIC TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·TOTAL JOINT ORTHOPEDICS, INC.·Product code JWH·August 18, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
SCREW, UNKNOWN TYPE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019
SCREW, UNKNOWN TYPE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019
MATRIX SCREW Ø1.85 SELF-TAP L5 TAN 1U I/
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JEY·June 22, 2013
UNICEL DXI 800 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·July 8, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008