8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CM ALVIM IMPLANT 3.5X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·November 8, 2017
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
FDA 510(k)
FDA Class 2
·Hematology
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EVAC 70 XTRA WITH INTEGRATED CABLE
FDA Adverse Event
Injury
·ARTHROCARE CORPORATION·Product code GEI·May 9, 2013
ACCU-CHEK ® ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 23, 2014
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 18, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021