10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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hCG One Step Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 5, 2021
Magic UCLA Abutment System
FDA 510(k)
FDA Class 2
·Dental
IOLMASTER 500
FDA 510(k)
FDA Class 2
·Ophthalmic
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW·Product code NXT·October 30, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
THINLINE
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021