meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
43
Latest Decision
1984-03-16

Clearances · page 44 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K834145 ERGO DIAGNOSTIC CARD American Ergo Systems HOX Class I 1984-03-16
K840444 NEONATE MASK FOR BABIES Richards Medical Co., Inc. HOY Class I 1984-03-16
K840471 EYE SPEAR Surgicot, Inc. HOZ Class II 1984-03-16
K834355 MICRO FORCEPS Jedmed Instrument Co. HNR Class I 1984-03-16
K834453 PHACO FRAGMENTOR GT-1 Fibra Sonics, Inc. HQC Class II 1984-03-16
K834305 ARGON/KRYPTON ION LASER PHOTOCOAGULA Nidek, Inc. HQF Class II 1984-03-16
K834537 MICRO VIT FRAGMENTATION SYSTEM Medical Instrument Development Laboratories, Inc. HQC Class II 1984-03-16
K840660 POSTERIOR CAPSULOTOMY CYSTITOME Sharpoint, Inc. HNY Class I 1984-03-16
K834261 PLASTIC OPTICAL LENS M-110 U-Molde Systems, Inc. HQC Class II 1984-03-16
K840310 CATEGORY 6 OPTHALMIC DEVICES Imm Enterprises , Ltd. HOB Class I 1984-03-16
K840659 ANTERIOR CAPSULECTOMY CYSTITOME Sharpoint, Inc. HNY Class I 1984-03-16
K834356 EYE SPONGE OR SPEAR Jedmed Instrument Co. HOZ Class II 1984-03-16
K834543 OCUCARE ULTRASOUND TIP & FREEDOM PACK Intermedics Intraocular, Inc. HQC Class II 1984-03-16
K834546 SURGICAL KNIFE Fine-Cut Diamond Instruments HNN Class I 1984-03-16
K840101 EYE SURGERY INSTRUMENT Truline Instruments, Inc. HOB Class I 1984-03-16
K840442 STERILIZED DISPOS. CYSTOTOME Microsurgical Technology, Inc. HMX Class I 1984-03-16
K833465 DISPOSABLE FIBER OPTIC ILLUMINATOR CooperVision, Inc. HQC Class II 1984-03-15
K833962 KPE PLUS-PAK SURGICAL SYSTEM Ipax, Inc. HQC Class II 1984-03-12
K833961 I/A PLUS PAK SURGICAL SYSTEM Ipax, Inc. HQC Class II 1984-03-12
K833446 DOWNING SPECTRAL ILLUMINATOR Vision Health Technology HLX Class II 1984-03-12
K833783 DISPOS. I/A & IRRIGATION HANDPIECES CooperVision, Inc. HQC Class II 1984-03-05
K833538 DOWING OPHTHALMIC CHAIR-NON/AC POWER Vision Health Technology HMD Class I 1984-03-05
K833539 DOWING OPHTHALMIC CHAIR AC-POWERED Vision Health Technology HME Class I 1984-03-05
K833642 PHAKO SYSTEMS VIA 2000 Pharosystems, Inc. HQC Class II 1984-03-05
K834187 JAKOBI SURG. INSTRUMENTS #6 50 Imm Enterprises , Ltd. HKY Class II 1984-03-05
K833694 TEXAS BIO SCAN Texas Bio Scan HKI Class II 1984-03-02
K833401 OMYL -ARDE- SPECTACLE FRAME I.J. Langleb , Ltd. HQZ Class I 1984-02-21
K833784 DISPOSABLE I/A HANDPIECE CooperVision, Inc. HQC Class II 1984-02-21
K832555 OCUMAP 100 AUTOPERIMETER Shorashim HPT Class I 1984-02-10
K833256 CROUCH CORNEAL PROTECTOR Star Instrument Co. HOY Class I 1984-02-08
K833532 OCULASE 514 OPHTHALMIC ARGON LASER Lasermed Corp. HQF Class II 1984-02-04
K834060 RELIANCE OPHTHALMIC SLIT LAMP R-083 F. & F. Koenigkramer HQF Class II 1984-02-04
K833533 LASER PHOTOCOAGULATOR 1520-A & K Britt Corp., Inc. HQF Class II 1984-01-30
K832703 ARGON LASER SYS-MODEL 5000 Cooper Medical Corp. HQE Class II 1984-01-30
K832316 OPHTHALMIC ARGON LASER #700A Laser Industries , Ltd. HQF Class II 1984-01-30
K832089 MODEL 150K LASER COAGULATOR Lasertek OY HQF Class II 1984-01-30
K833229 SUN BED BY VERRE ET QUARTZ UVA-FRANCE H & M Douglas Enterprises, Inc. FTZ Class I 1984-01-27
K832912 GELENDER VACUUM FIXATION RING SYS Miami Eye Technology, Inc. HNH Class I 1984-01-10
K833671 STERILE OIL AND GUIDEWIRE CooperVision, Inc. HNL Class I 1984-01-10
K833405 IRRIGATION ASPIRATION KIT American Medical Optics HQC Class II 1984-01-06
K833778 TESTING VISUAL ACUITY Technical Enginuities Co. HOX Class I 1984-01-04
K833956 DOT VISUAL ACVITY TEST 2000 Good-Lite Co. HOX Class I 1984-01-04
K833820 MACHEMER/TANO ROTATING Optical Micro Systems, Inc. HRJ Class I 1984-01-04
K832843 OSCAR COLOUR VISION TESTER Keeler Instruments, Inc. HIT Class I 1984-01-04
K833064 STORZ EXTRA Storz Instrument Co. HQC Class II 1984-01-04
K833800 BEECHER 20 GA. PROBE Beecher Medical Diagnostic Instrumentation HQC Class II 1984-01-04
K832529 M.S.D. ASPIRATOR Medical Surgical Designs HQC Class II 1984-01-04
K833494 CLERZ LUBRICATING/REWETTING SOLUTION CooperVision, Inc. HKX Class II 1984-01-04
K833371 DISPOSABLE OCUTOME PROBE CooperVision, Inc. HQE Class II 1984-01-04
K833232 LASER PROTECTIVE EYESHIELD Stefanovsky & Assoc. HQF Class II 1983-12-30
K834161 UNIVERSAL PAC American Surgical Co., Inc. HQC Class II 1983-12-28
K833697 EXTRA SENSORY PAK-DISPOS. ACCESS American Surgical Co., Inc. HQC Class II 1983-12-28
K834159 PHACOTRON PLUS American Surgical Co., Inc. HQC Class II 1983-12-28
K834158 EXTRA SENSORY PLUS American Surgical Co., Inc. HQC Class II 1983-12-28
K833617 EXTRA PLUS TM American Surgical Co., Inc. HQC Class II 1983-12-28
K834163 ULTRAVIT American Surgical Co., Inc. HQE Class II 1983-12-28
K833274 DERMATOLOGY HANDPIECE-OPHTH LASER Synemed, Inc. HQF Class II 1983-12-03
K832996 SURGICAL IOP MONITOR Miami Eye Technology, Inc. HKY Class II 1983-11-28
K831829 KARICKHOFF FLYING CORPUSCLE VIEWER Surgidev Corp. HIX Class I 1983-10-19
K832446 CATAREX DIAP. EXTRACAPSULAR CATARACT Calliope Corp. HQE Class II 1983-10-19
K832950 SCIENTRONICS 10K EYE MAGNET Scientific Manufacturer HPO Class II 1983-10-19
K832980 VXTRA OCUTOME KIT Vxtra Corp. HQC Class II 1983-10-19
K832997 EPA AUTOMATED INFUSION POLE Miami Eye Technology, Inc. HQC Class II 1983-10-04
K832413 SIAS IRRIGATION/ASPIRATION SYSTEM Clark Pool & Assoc. HQC Class II 1983-10-04
K832787 ELECATH HEPARIN COATED THERMAL DILUTION Electro-Catheter Corp. KYG Class I 1983-10-04
K832939 I-GLIDE IOL IMPLANTATION AID I For M, Inc. KYB Class I 1983-10-04
K832235 DISPOSABLE VITRECTOMY HANDPIECE Innovative Surgical Products, Inc. HQE Class II 1983-09-29
K832844 RUBY KNIVES FOR OPHTH. SURGERY Keeler Instruments, Inc. HNN Class I 1983-09-29
K832911 ABBOTT GLOBE HOLDER Miami Eye Technology, Inc. HJO Class II 1983-09-29
K832762 MILLER/NADLER GLARE TESTER Titmus Optical, Inc. HLX Class II 1983-09-29
K832559 OCUCARE FREEDOM PACK Ocular Innovations, Inc. HQC Class II 1983-09-29
K832800 AUTOMATIC TANGENT SCREEN 50 CooperVision, Inc. HOO Class I 1983-09-29
K832481 SCLERAL BUCKLING IMPLANTS DIF/TYPES Storz Instrument Co. HQX Class II 1983-09-20
K832564 DISCO SUNGLASSES/HEADBAND SUNGLASSES E-Tay Industrial Co. , Ltd. HQY Class I 1983-09-12
K832423 ENVISION G21 I/A ENPAK Envision, Inc. HQC Class II 1983-09-12
K832424 ENVISION G31 P.E. PAK Envision, Inc. HQC Class II 1983-09-12
K831975 LEADING EDGE OPHTHALMIC KNIFE Surgidev Corp. HNN Class I 1983-08-31
K832437 MEDIC LUX DIAGNOSTIC SETS Keeler Instruments, Inc. HLJ Class II 1983-08-16
K832175 DIGILAB 350 THE KRAKAU PERIMETER Bio-Rad HPT Class I 1983-08-16
K831773 MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK Bcd Products, Inc. HQJ Class II 1983-08-16
K832181 SNO STRIPS STERILE TEARFLOW TEST STRIP Smith & Nephew, Inc. KYD Class I 1983-08-12
K832073 ELECTRIC INSTRUMENT TABLE CooperVision, Inc. HMF Class I 1983-08-12
K831584 BAILEY ASPIRATOR/IRRIGATOR Medical Instrument Development Laboratories, Inc. HQE Class II 1983-08-12
K832074 CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA CooperVision, Inc. HKP Class II 1983-08-01
K832142 DICON GLAUCOMA DIAG. CENTER 2000 SERIES CooperVision, Inc. HPT Class I 1983-08-01
K831701 UNIVERSAL PACK Atlantic Optical Systems, Inc. HQC Class II 1983-07-12
K831916 DISPOSABLE CYSTOTOME CooperVision, Inc. HNY Class I 1983-07-12
K831996 MICRO SURGICAL HANDLE Visitec Co. KYG Class I 1983-07-12
K831901 LACIMAL INTUBATION SETS Visitec Co. HNL Class I 1983-07-12
K831532 OCULAR IRRIGATING CANNULA Dey Laboratories, Inc. HMX Class I 1983-07-12
K831193 SCLERAL PLUG Medical Instrument Development Laboratories, Inc. LXP Class II 1983-06-30
K831192 INFUSION CANNULA Medical Instrument Development Laboratories, Inc. HMX Class I 1983-06-30
K831836 EPSILON ULTRASONIC TIP CooperVision, Inc. HQC Class II 1983-06-30
K831702 RARE-EARTH INTRA-OCULAR MAGNET Miami Eye Technology, Inc. HPN Class I 1983-06-30
K831084 SUN PHOTO-KERATOSCOPE Nidek, Inc. HLQ Class I 1983-06-30
K830430 EYELID SPECULUM Douglas C. Mckee & Co. HNC Class I 1983-06-10
K830738 LENSERT CONTACT LENS CLEANING & INSERT Jermyn Specialties of California KYE Class I 1983-06-10
K831266 MICROSURGICAL KNIFE Vxtra Corp. HNN Class I 1983-06-10
K831083 AUTO REFRACTOMETER Nidek, Inc. HKO Class I 1983-06-10
K831172 ULTRAKIT Staar Surgical Co. HQC Class II 1983-06-08

4,756 clearances in the Ophthalmic panel. Data: openFDA.