8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM
FDA 510(k)
FDA Class 1
·Microbiology
MICROFUSE DUAL RATE INFUSER
FDA 510(k)
FDA Class 2
·General Hospital
EBS 775 TONOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 8, 2018
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·May 5, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 15, 2012
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 10, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025