16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ulrichINJECT CT motion
FDA 510(k)
FDA Class 2
·Cardiovascular
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383549615·Gutta Percha Points is used to root canal filin...
PXS-810, PODIATRY X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 5, 2024
NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 5, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
ALT HA S CLR EXT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·November 14, 2023
REAMER Ø11 F/PFNA BLADE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·June 15, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 30, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 17, 2008
NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 31, 2024
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·August 12, 2024
BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 3, 2024
NV GXL LINER LIPPED 36MM ID GROUP 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·November 1, 2022
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016