9 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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FDA 510(k)
FDA Class 2
·Radiology
Steril Peel
FDA UDI
AMD Medicom Inc·D830221432·STERIL-PEEL TUBING/ROLL 2" X 100'
Masimo O3 Regional Oximeter System
FDA 510(k)
FDA Class 2
·Cardiovascular
Myomics Q
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 3, 2014
PRIME ZOOM STRETCHER, 30" LITTER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·August 16, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 11, 2013
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020