38 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
FDA 510(k)
FDA Class 2
·Radiology
Ring CT/MR Applicator
FDA UDI
Nucletron B.V.·08717213038646·Intrauterine Tube (4 mm), L=20 mm, 30°
My Medical
FDA UDI
My Medical Store LLC·G4251106670·Biggs Facelift Retractor Fiberoptic
110-667
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306817113·Biggs Mammoplasty Retractor, No Fiberoptic or S...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306817106·Biggs Mammoplasty Fiberoptic Retractor with Suc...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306817083·Biggs Mammoplasty Fiberoptic Retractor, Blade W...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306817120·Biggs Mammoplasty Fiberoptic Retractor, Blade W...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306817090·Biggs Mammoplasty Retractor, No Fiberoptic or S...
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)
FDA 510(k)
FDA Class 2
·Cardiovascular
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 13, 2023
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 23, 2023
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 26, 2023
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 31, 2023
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 27, 2023
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
FLEXIBLE DEPTH GAUGE
FDA Adverse Event
Malfunction
·GREATBATCH MEDICAL SA·Product code LXH·September 16, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 1, 2011
ULTRA FAST-FIX ASSEMBLY - CURVED
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GAT·September 14, 2023
PEDIASAT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025