9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XP202
FDA 510(k)
FDA Class 2
·Dental
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
VOCARE MYHEALTH TABLET
FDA 510(k)
FDA Class 2
·Cardiovascular
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
FDA 510(k)
FDA Class 1
·Clinical Toxicology
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 10, 2014
MOSS MIAMI 6.0 X 50MM POLYAXIAL SCREW
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code MNH·July 11, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 11, 2013
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
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