9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 16, 2013
MAZOR X SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
FDA Enforcement
Class II
·Ongoing·Diasorin Inc.·December 18, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025