34 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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USTAR II System
FDA 510(k)
FDA Class 2
·Orthopedic
Phasix
FDA UDI
Davol Inc.·00801741077661·Phasix Mesh, 3" (7.6 cm), Circle
LEONE SPA
FDA UDI
LEONE SPA·08033707069393·LOOP FORMING PLIERS TWEED STYLE
MClass
FDA UDI
Conmed Corporation·10845854020982·MCLASS OSCILLATING SAW BLADE 19 X 1.00 (0.039")...
SOFTSEAL-STF
FDA 510(k)
FDA Unclassified
·Unknown
DIO STEADY EXTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069423860·Widex T-DEX (complete) (DEX silver )
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LKK·June 8, 2006
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 1, 2024
FMC ARTERIAL BLOODLINE
FDA Adverse Event
Injury
·FMC USA·Product code FII·March 9, 2000
FLEXIFLO GASTROSTOMY TUBE
FDA Adverse Event
Injury
·ROSS PRODUCTS DIV/ABBOTT LABORATORIES·Product code KNT·May 1, 2001
POLYFLUX
FDA Adverse Event
Injury
·VANTIVE US HEALTHCARE LLC·Product code FJI·May 22, 2025
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
TRILOGY O2
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·June 18, 2013