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 4, 1983K832413SIAS IRRIGATION/ASPIRATION SYSTEM
Clark Pool & Assoc.
HQC
Sep 29, 1983K832559OCUCARE FREEDOM PACK
Ocular Innovations, Inc.
HQC
Sep 12, 1983K832424ENVISION G31 P.E. PAK
Envision, Inc.
HQC
Sep 12, 1983K832423ENVISION G21 I/A ENPAK
Envision, Inc.
HQC
Jul 12, 1983K831701UNIVERSAL PACK
Atlantic Optical Systems, Inc.
HQC
Jun 30, 1983K831836EPSILON ULTRASONIC TIP
CooperVision, Inc., GB
HQC
Jun 8, 1983K831172ULTRAKIT
Staar Surgical Co.
HQC
Jun 8, 1983K830812ALPHAMEDIX I/A HAND-PIECE, 500-001
Alphamedix, Inc.
HQC
May 16, 1983K830902OCUCARE PACK
Ocular Innovations, Inc.
HQC
Apr 6, 1983K823088ASPITRON
Intl. Ophthalmic Industries Corp.
HQC
Apr 5, 1983K830474IV STAND
Teknar, Inc.
HQC
Apr 5, 1983K830385IRRIGATION/ASPIRATION KIT
Vxtra Corp.
HQC
Apr 5, 1983K830379PHAKO KIT
Vxtra Corp.
HQC
Sep 18, 1981K812126ULTRASONIC TIPS
CooperVision, Inc., GB
HQC
Dec 17, 1980K802381LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.
Fibra Sonics, Inc.
HQC
Jan 26, 1979K782141LEVIGATOR, KEELER PHOKO
Keeler Optical Products , Ltd.
HQC
Sep 26, 1977K771644FRAGMATOME MODEL 820
Berkeley Bio-Engineering
HQC

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