8 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIR INCENTIVE SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
CABG RINGS
FDA 510(k)
FDA Class 2
·Cardiovascular
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
FDA 510(k)
FDA Unclassified
·Unknown
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 15, 2012
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NUJ·January 22, 2014
AXXESS QUAD 3/6 PERCUTANEOUS LEAD
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 4, 2010
Azurion 7 M20. Fluoroscopic X-Ray System.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·July 30, 2025
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025