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Panels › Gastroenterology, Urology › Product code OWN · Class 2

Confocal Optical Imaging

Regulation 876.1500

8510(k)s in 12 months (63 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in OWN

Company510(k)sRecalls
Mauna Kea Technologies160
Visionsense, Ltd.43
KARL STORZ Endoscopy-America, Inc.60
Stryker60
Karl Storz SE & CO. KG40
Novadaq Technologies Ulc. (Now A Part of Stryker)40
Activ Surgical, Inc.20
Medtronic20
Olympus Medical Systems Corp.20
SmartsurgN, Inc.20
Decided510(k)Device and applicantCode
Jun 30, 2015K143474Artemis Hand Held Imaging System
Quest Medical Imaging, NL
OWN
Jun 17, 2015K150018VS3-IR-MMS System
Visionsense, Ltd., IL
OWN
Dec 2, 2014K142310Stryker Infrared Fluorescence (IRF) Imaging System
Stryker Endoscopy
OWN
Sep 25, 2014K141358CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
Mauna Kea Technologies
OWN
Jul 25, 2014K133466CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
Mauna Kea Technologies
OWN
May 7, 2014K132475FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
Fluoptics
OWN
Feb 25, 2014K132389CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED
Daniel & Daniel Consulting
OWN
Sep 13, 2013K124031DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
Intuitive Surgical, Inc.
OWN
Apr 18, 2013K123676CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
Mauna Kea Technologies
OWN
Sep 4, 2012K122042CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
Mauna Kea Technologies
OWN
Apr 20, 2012K120208CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
Mauna Kea Technologies
OWN
Jan 13, 2012K110480PDE PHOTODYNAMIC EYE
Hamamatsu Photonics K.K.
OWN
Aug 8, 2011K111047CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
Mauna Kea Technologies, Inc.
OWN

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