8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SuperSlyde Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BIOXTRA MOISTURIZING GEL
FDA 510(k)
FDA Unclassified
·Unknown
SYNOVIS COLLAGEN MATRIX (TBD)
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 17, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 18, 2008
UNICEL DXC 600 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CGA·June 24, 2011
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
FDA Enforcement
Class II
·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·June 12, 2019
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023