8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
FDA 510(k)
FDA Class 2
·Dental
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Solax Powered Wheelchair (Models: S7101, S7103)
FDA 510(k)
FDA Class 2
·Physical Medicine
SMART PERFUSION PACK: APEX MBR FMC/MID WEST REG LEXINGTON, KY
FDA Adverse Event
Injury
·Product code DTZ·September 11, 2007
SUPERIOR PLATE
FDA Adverse Event
Injury
·SYNTHES (USA) BRANDYWINE·Product code MJO·February 26, 2013
24FR 30 CUTTING LOOP ELECTRODE, .014 (6BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code GEI·January 14, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·August 6, 2014
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020