8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NATRACARE TAMPON
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Damon 3
FDA UDI
ORMCO CORPORATION·00889989003550·L3R DAMON 3 .022 0/+5/0
MENS FREEDOM MICRO
FDA 510(k)
FDA Class 2
·Neurology
HEMOCARD-AS
FDA 510(k)
FDA Class 2
·Hematology
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·December 3, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 14, 2013
VG 360 DST FM AG 65X5 RL/LM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 3, 2014
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018