9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KLS Martin Drill-Free MMF Screw
FDA 510(k)
FDA Class 2
·Dental
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917021768·Personal Use Kit OC-Auto, for The Villages, FL
Washing Solution Concentrate
FDA UDI
Phadia AB·07333066012490·Washing Solution Concentrate
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
FDA 510(k)
FDA Class 2
·Orthopedic
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
FDA 510(k)
FDA Class 2
·General Hospital
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·September 3, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025