8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDPAR SURGICAL IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DESIGNS FOR VISION FIBEROPTIC LIGHT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PhySoftAMS®
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMARA VIEW
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·July 9, 2025
HTR-PEKK
FDA Adverse Event
Injury
·OXFORD PERFORMANCE MATERIALS·Product code GXN·April 14, 2014
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 14, 2012
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2015
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Enforcement
Class II
·Ongoing·Isopure Corp·July 20, 2022