12 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLYTUBE
FDA 510(k)
FDA Unclassified
·Unknown
Jelco
FDA UDI
ICU MEDICAL, INC.·20351688059991·
Pacific Blue™ anti-human CD45
FDA UDI
BIOLEGEND, INC.·00810034700919·URL: https://www.biolegend.com/en-us/products/p...
Jelco
FDA UDI
ICU MEDICAL, INC.·15019517050103·
Sunkingdom Slit Lamp
FDA 510(k)
FDA Class 2
·Ophthalmic
POWERLOC CLEAR SAFETY INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
SMART PERFUSION PACK: APEX MBR FMC/MID WEST REG LEXINGTON, KY
FDA Adverse Event
Injury
·Product code DTZ·September 11, 2007
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·February 25, 2013
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 9, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 5, 2014
FIXED ANGLE GUIDE OMEGA 135°
FDA Adverse Event
Malfunction
·STRYKER TRAUMA SELZACH·Product code LXH·June 11, 2014
Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number PSS2798(C Custom Pack, part number PSS3463
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017