13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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iSR'obot MRI-US Fusion
FDA 510(k)
FDA Class 2
·Radiology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515023208·Foerster Sponge Fcps, 9 1/2", str smth jaws
Sentry
FDA UDI
Life Spine, Inc.·00190837034245·Osteophyte Removal Tool
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141790·ZEUS®-L Cup Curette Straight, Angled Tip 4mm
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
VIVATRAK
FDA 510(k)
FDA Class 1
·General Hospital
AERODR X70
FDA 510(k)
FDA Class 2
·Radiology
OT PING METER
FDA Adverse Event
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
POLYFLUX R CAPILLARY DIALYZER
FDA Adverse Event
Other
·GAMBRO DIAYLSATOREN GMBH·Product code KDI·July 11, 2008
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 17, 2011
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·September 28, 2022
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022