8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIMSTICK PBD PREGNANCY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OLYMPUS ALBUMIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PART 872 DEGUFILL H & DEGUFILL M DA
FDA 510(k)
FDA Class 1
·Dental
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·February 19, 2013
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·August 1, 2014
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
IRC2100 W/ 210 LIGHTGUIDE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code KNS·August 28, 2019
SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 14, 2024