9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tracheal Stent System (Y-Shaped)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002060·External 4.0mm x 3mm Flared Healing Abutment
VANGUARD REPROCESSED COMPRESSION GARMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
AMSCO CHIMERON MEDIUM STEAM STERLILZER
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
IPUMP PAIN MANAGEMENT SYSTEMUS VERSION
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION, SINGAPORE·Product code FRN·October 29, 2008
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023