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FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K161794 CENTURION Vision System (Active SentryTM)HQC2017-04-14 View
510(k) K170520 HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+MLZ2017-03-22 View
510(k) K121031 WAVELIGHT FS200 PATIENT INTERFACE 1505GEX2012-06-21 View
510(k) K112977 MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)MSS2012-03-27 View
510(k) K110951 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULAHQB2011-10-17 View
510(k) K110166 CLEARCUT S SAFETY KNIFEHNN2011-05-20 View
510(k) K102860 ALCON MULTI-PIRPOSE DISINFECTING SOLUTIONLPN2011-05-10 View
510(k) K101006 WAVELIGHT FS200 LASER SYSTEM MODEL: FS200GEX2010-10-21 View
510(k) K093305 ENHANCED ULTRA VIT PROBEMLZ2010-04-02 View
510(k) K091777 ALCON ULTRACHOPPERHQC2009-10-20 View
510(k) K082845 INFINITI VISION SYSTEM WITH OZIL IPHQC2009-02-12 View
510(k) K062930 LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEMNCF2006-11-08 View
510(k) K050729 ALCON MULTI-PURPOSE DISINFECTING SOLUTIONLPN2005-09-14 View
510(k) K003768 MONARCH II IOL DELIVERY SYSTEMMSS2001-01-05 View
510(k) K001157 MONARCH II IOL DELIVERY SYSTEMKYB2000-06-27 View
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