9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Everyway Analog OTC TENS, model N103A/N302
FDA 510(k)
FDA Class 2
·Neurology
BODY CLOCK TENS N' TONE
FDA 510(k)
FDA Class 2
·Neurology
FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE
FDA Adverse Event
Malfunction
·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025
HT70 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·November 4, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·November 6, 2008
NA
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code NUJ·July 12, 2013
ZILVER 635 VASCULAR SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code NIO·October 5, 2018
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025