9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aygün Sterilization Container Systems
FDA 510(k)
FDA Class 2
·General Hospital
Critical Cover
FDA UDI
Alpha Pro Tech, Inc.·10817583023114·Scrub Pants, AlphaGuard, Dark Blue, Spandex Ela...
SAAD PATIENT MONITOR (SPM)
FDA 510(k)
FDA Class 2
·Cardiovascular
OLYMPUS STERILIZATION TRAYS
FDA 510(k)
FDA Class 2
·General Hospital
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·January 31, 2019
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 6, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·July 22, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 18, 2013
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025