14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
FDA 510(k)
FDA Class 2
·Microbiology
Truline
FDA UDI
Arbill Industries, Inc.·10850052602021·
PINNACLE®
FDA UDI
B. BRAUN MEDICAL INC.·04046964200373·PINNACLE® 6-Lead Non-Vented Transfer Set
Truline
FDA UDI
Arbill Industries, Inc.·00850052602260·Made in Malaysia. Blue disposable Nitrile. Size...
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TECNIS ITEC PRELOADED 1-PIECE IOL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·May 14, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 3, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
FLEXI SEAL SIGNAL (FMS)
FDA Adverse Event
Injury
·CONVATEC INC.·Product code KNT·October 11, 2016
WALLFLEX? BILIARY TRANSHEPATIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012
BD INTEGRA
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·December 21, 2024
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025