346 results · 39ms · Sources: EU EUDAMED, US FDA
Filters Fda510k ×

DEVON COOL FACE

FDA 510(k)
FDA Class 1 ·General Hospital

VINYL ICE BAG

FDA 510(k)
FDA Class 1 ·General Hospital

ICE BAG, VINYL

FDA 510(k)
FDA Class 1 ·General Hospital

SAV-A-LIMB

FDA 510(k)
FDA Class 1 ·General Hospital

CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

EXALIS, SOFTWARE VERSION 1.15

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MOLECULAR ADSORBENT RECIRCULATING(MARS)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SPECTACLE PRESCRIPTION LENSES

FDA 510(k)
FDA Class 1 ·Ophthalmic

PHOENIX HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX SYSTEM 7.10

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX M150 SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology