10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Bernafon AG·05711584114056·CO1 B 105, 2.4G NFM SABE DEMO CAPTO 1 GPL
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEEP GRAY
FDA 510(k)
FDA Class 2
·Radiology
DUOVISC
FDA Adverse Event
Injury
·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code LZP·October 24, 2008
ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·August 11, 2011
TELIGEN
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWP·July 9, 2013
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
BD KIESTRA¿ IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·December 9, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024