ClearanceBrief
Panels › Ophthalmic › Product code HQC · Class 2

Unit, Phacofragmentation

Regulation 886.4670

4510(k)s in 12 months (317 all time)
0recalls in 12 months (74 all time)
61recalls that name a 510(k)
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Top companies in HQC

Company510(k)sRecalls
Alcon Research, LLC430
Bausch & Lomb1118
Storz Instrument Co.170
Chiron Vision Corp.150
CooperVision, Inc.150
Site Microsurgical Systems, Inc.140
Alcon Research LTD dba Alcon Laboratories, Inc.011
Abbott Medical Optics, Inc.91
Johnson & Johnson Surgical Vision, Inc.27
Alcon Laboratories80
Decided510(k)Device and applicantCode
Oct 20, 2009K091777ALCON ULTRACHOPPER
Alcon Research, Ltd.
HQC
Feb 12, 2009K082845INFINITI VISION SYSTEM WITH OZIL IP
Alcon Research, Ltd.
HQC
Jan 5, 2009K082473BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
Bausch & Lomb, Inc.
HQC
Jan 5, 2009K081877ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
Dutch Ophthalmic Research Center International BV, NL
HQC
Sep 22, 2008K080803VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
American Optisurgical, Inc.
HQC
Aug 28, 2008K082132BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
Bausch & Lomb, Inc.
HQC
May 9, 2008K063583ALCON VISION SYSTEM
Alcon
HQC
Mar 12, 2008K073023STERILS SINGLE-USE I/A HANDPIECES
Bausch & Lomb, Inc.
HQC
Dec 19, 2006K063331BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
Bausch & Lomb, Inc.
HQC
Apr 7, 2006K060366THE AMO OPHTHALMIC SURGICAL SYSTEM
Advanced Medical Optics, Inc.
HQC
Aug 18, 2005K051186MICROPULSE PHACOEMULSIFICATION SYSTEM
Trillium Medical, Inc.
HQC
Apr 5, 2005K050648SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
Advanced Medical Optics, Inc.
HQC
Aug 16, 2004K041998PHACO CHOP NEEDLES
Bausch & Lomb, Inc.
HQC
Dec 17, 2003K033653VENTURI PHACO PACK
Bausch & Lomb, Inc.
HQC
Aug 20, 2003K030957PERFECT CAPSULE
Milvella Pty. , Ltd.
HQC
May 22, 2003K031404DIGNITY OPHTHALMIC SURGICAL SYSTEM
Phacor Inc., A Santen Company
HQC
Sep 9, 2002K022833BENJAMIN ENVOY PHACO HANDPIECE
Benjamin Biomedical, Inc.
HQC
Jul 9, 2002K020527HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
American Optisurgical, Inc.
HQC
Jul 2, 2002K021566INFINITI
Alcon Laboratories, Inc.
HQC
May 16, 2002K020734SURGE-FREE ASPIRATION ADAPTER
Staar Surgical Co.
HQC
Feb 13, 2001K003638MOJAVE CATARACT EXTRACTION SYSTEM
Allergan, Inc.
HQC
Feb 8, 2001K003512LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
A.R.C. Laser AG
HQC
Jan 4, 2001K002932PHACOGARD
Syntec, Inc.
HQC
Dec 27, 2000K002031PHACOFRAGMENTATION SYSTEM MEGATRON
Asclepion-Meditec AG
HQC
Nov 29, 2000K002986A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
A.R.C. Laser AG
HQC
Nov 8, 2000K002812IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
Michael Reynard, M.D.
HQC
Jul 7, 1999K991852OCUSYSTEM ART ADVANTAGE, MODEL 995
Surgical Design Corp.
HQC
Feb 16, 1999K984143FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
Fibra Sonics, Inc.
HQC
Aug 25, 1998K981989THE WAVE DIGITAL PHACO SYSTEM
Circuit Tree
HQC
Jun 23, 1998K981103TURBOSONICS LIMITED REUSE ULTRASONIC TIP
Alcon Laboratories
HQC
Jun 9, 1998K981109QUITETIP
Paradigm Medical Industries, Inc.
HQC
May 4, 1998K980480SYNTEC VITMAN
Syntec, Inc.
HQC
Feb 24, 1998K980085PHACO COMMANDER
Scieran Technologies, Inc.
HQC
Feb 24, 1998K974469MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
Mentor Corp.
HQC
Jan 20, 1998K974719PHACOPAK
Paradigm Medical Industries, Inc.
HQC
Dec 8, 1997K973749FRAG COMMANDER
Scieran Technologies, Inc.
HQC
Nov 25, 1997K972063WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
William F. Whittingham
HQC
Jul 29, 1997K972253P3 UNIVERSAL PHACO HANDPIECE
Odyssey Technologies, Inc.
HQC
Jul 29, 1997K972252VISTA UNIVERSAL HANDPIECE
Odyssey Technologies, Inc.
HQC
Jul 14, 1997K971795AUTOMATED CHAMBER MAINTENANCE MODULE
Paradigm Medical Industries, Inc.
HQC
Jun 30, 1997K971750WELCH ALLYN PHACO ILLUMINATOR
Welch Allyn, Inc.
HQC
Jun 17, 1997K971439STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
Storz Instrument Co.
HQC
Jun 13, 1997K971186AMO DIPLOMAX/OPSYS CONSOLE
Allergan, Inc.
HQC
Jun 9, 1997K971064BAYERS BIMANUAL I/A HANDPIECES
Visioncare Devices, Inc.
HQC
Mar 17, 1997K965127DGH MODEL 9000
Dgh Technology, Inc.
HQC
Feb 26, 1997K964018PHACOILLUMINATOR - FIBEROPTIC SLEEVE
Michael Reynard, M.D.
HQC
Nov 5, 1996K960287HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
Nidek, Inc.
HQC
Oct 2, 1996K960811PHACOSCOPE
Saint John'S Plaza Medical Group
HQC
Sep 20, 1996K960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH
Storz Instrument Co.
HQC
Sep 19, 1996K962402AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
Allergan, Inc.
HQC

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