meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
37
Latest Decision
1988-04-13

Clearances · page 37 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K875002 PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874969 PRISMA DISPOSABLE KRATZ CAPSULE POLISHER Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874977 PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874976 PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME Advanced Surgical Products, Inc. HNY Class I 1988-04-13
K874990 PRISMA DISPOSABLE SILICONE BULB Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874997 PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME Advanced Surgical Products, Inc. HNY Class I 1988-04-13
K874989 PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K875003 PRISMA DISPOSABLE PUPIL CENTERING CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874999 PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874984 PRISMA DISPOSABLE MICRO IRRIGATING VECTUS Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874971 PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K875000 PRISMA DISPOSABLE ENDO-OCULAR PROBE Advanced Surgical Products, Inc. HQF Class II 1988-04-13
K881232 SURGIN EYE SHIELD Surgeon Surgical Instrumentation, Inc. HOY Class I 1988-04-13
K874975 PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME Advanced Surgical Products, Inc. HNY Class I 1988-04-13
K874993 PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME Advanced Surgical Products, Inc. HNY Class I 1988-04-13
K874968 PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874994 PRISMA DISPOSABLE ANGLED I/A CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K875001 PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME Advanced Surgical Products, Inc. HNY Class I 1988-04-13
K874970 PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874992 PRISMA DISPOSABLE IRRIGATING LENS DIALER Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874978 PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874972 PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874998 PRISMA DISPOSABLE U-SHAPED CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874988 PRISMA DISPOS. PEARCE IRRIGATING VECTUS W/ONE PORT Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874980 PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874983 PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME Advanced Surgical Products, Inc. HNY Class I 1988-04-13
K874995 PRISMA DISPOS. CURVED LACHRYMAL CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874985 PRISMA DISPOSABLE CAPSULE POLISHER Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874986 PRISMA DISPOSABLE RETROBULBAR NEEDLE Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874973 PRISMA DISPOSABLE SIMCOE I/A CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874987 PRISMA DISPOSABLE DOUBLE I/A CANNULA Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874982 PRISMA DISPOSABLE SIMCOE EXTRACTOR Advanced Surgical Products, Inc. HMX Class I 1988-04-13
K874991 PRISMA DISPOSABLE IRRIGATING IRIS HOOK Advanced Surgical Products, Inc. HNQ Class I 1988-04-13
K881059 MCT 8000 (MULTI-VISION CONTRAST TESTER) Vistech Consultants, Inc. HOX Class I 1988-04-04
K873965 FRAME, SPECTACLE Swank Plus , Ltd. HQZ Class I 1988-04-01
K881022 VCTS MARKETING PROGRAM SYSTEM Vistech Consultants, Inc. HOX Class I 1988-04-01
K880709 CALIFORNIA CONVERTIBLES (SUNGLASSES) Jmj World Trade Corp. HQY Class I 1988-04-01
K881023 VCTS 6500 SYSTEM Vistech Consultants, Inc. HOX Class I 1988-04-01
K880675 EASY SHIELD ADHESIVE BANDAGE Eye Garter Company, Inc. HOY Class I 1988-04-01
K880647 ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) Fred Sammons, Inc. HOX Class I 1988-04-01
K881021 VCTS 700S SYSTEM Vistech Consultants, Inc. HOX Class I 1988-04-01
K881094 KOI(TM) BLADE GAUGE, MODEL KOI-132 CooperVision, Inc. HOE Class I 1988-04-01
K880855 PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG Richard James, Inc. HPN Class I 1988-04-01
K875099 MOLTENO VALVE SETON Staar Surgical Co. KYF Class II 1988-03-30
K873823 MOBAY (BAYER) MAKROLON 2658 3291 Applied Laboratories, Inc. LRX Class II 1988-03-24
K873820 MOBAY (BAYER) MAKROLON 2658 1112 Applied Laboratories, Inc. LRX Class II 1988-03-24
K873825 GE LEXAN 144R 112 Applied Laboratories, Inc. LRX Class II 1988-03-24
K873821 GE NORYL 731-80089S Applied Laboratories, Inc. LRX Class II 1988-03-24
K873822 MOBAY (BAYER) MERLON M-40 (H)F 1112 Applied Laboratories, Inc. LRX Class II 1988-03-24
K873824 RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000 Applied Laboratories, Inc. LRX Class II 1988-03-24
K875302 MEDICAL EYE DISPOSABLE SHIELD Bfd, Inc. HOY Class I 1988-03-21
K875107 HEALTH CARE EYE PROTECTION Surgikos, Inc. HOY Class I 1988-03-21
K875237 OPTEC 1000 DMV VISION TESTER MODIFY Stereo Optical Co., Inc. HOX Class I 1988-03-17
K875112 MENTOR B-VAT(TM) II VIDEO TESTER Mentor O & O, Inc. HOX Class I 1988-03-08
K873853 DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0 Advanced Surgical Products, Inc. HMX Class I 1988-03-07
K880062 C-MATE #CMU 1001 O.R. Specialties, Inc. HQC Class II 1988-03-07
K873966 SUNGLASSES (NONPRESCRIPTION) Swank Plus , Ltd. HQY Class I 1988-02-26
K873967 SPECTACLE, MAGNIFYING Swank Plus , Ltd. HOT Class I 1988-02-26
K875014 LABTICIAN RETINAL IMPLANTS Labtician Products, Inc. HQJ Class II 1988-02-26
K875330 HOSKINS-BARKAN GONIOTOMY LENS 10MM Ocular Instruments, Inc. HJK Class II 1988-02-26
K875331 BICONCAVE VITRECTOMY LENS Ocular Instruments, Inc. HJK Class II 1988-02-26
K875063 SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. Epson EL Paso, Inc. HQG Class I 1988-02-22
K874722 HOLLYWOODS COOL SHADES Tonka Corp. HQY Class I 1988-02-19
K875087 PEYMAN G. 12.12 YAG LASER LENS Ocular Instruments, Inc. HJK Class II 1988-02-19
K875124 LOW-POWER BINOCULAR LOUPE Seiler Instrument & Mfg. Co., Inc. HOH Class I 1988-02-19
K875114 HOSKINS-BARKAN GONIOTOMY LENS 9MM Ocular Instruments, Inc. HJK Class II 1988-02-19
K875197 OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE Pro-Optics, Inc. LRX Class II 1988-02-09
K875026 ANOMALOSCOPE PLATE TEST - 5 [APT-5] Lkc Technologies, Inc. HIT Class I 1988-02-05
K873990 IRAS EDS INTERFEROMETRIC STIMULATOR Randwal Instrument Co., Inc. HLX Class II 1988-02-05
K874681 SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES Klockner Contract Packaging, Inc. HQG Class I 1988-02-05
K880274 ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS Advanced Surgical Products, Inc. HNR Class I 1988-02-05
K874555 KEELER ACU 22XT OPHTHALMIC CRYO UNIT Keeler Instruments, Inc. HPS Class II 1988-01-29
K874160 ZEISS 40 SL/P PHOTO SLIT LAMP Carl Zeiss, Inc. HJO Class II 1988-01-27
K874252 KREDA DISC Richmond Products, Inc. HOQ Class I 1988-01-27
K875067 GOOD LOOKS DAZZLERS Mel Appel HQY Class I 1988-01-26
K874355 OPACITY LENSMETER 701 Intraoptics, Inc. HKI Class II 1988-01-26
K874224 BIO-COR II COLLAGEN CORNEAL SHIELD Bausch & Lomb, Inc. MOE Class I 1988-01-22
K874225 BIO-COR EXT COLLAGEN CORNEAL SHIELD Bausch & Lomb, Inc. MOE Class I 1988-01-22
K874336 PATTERN DISCRIMINATION PERIMETER Lkc Technologies, Inc. HPT Class I 1988-01-12
K874251 WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT Richmond Products, Inc. HLP Class I 1988-01-11
K874334 SOLOS SINGLE USE TITANIUM TIP Solos Ophthalmology HQC Class II 1988-01-11
K874250 THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. Richmond Products, Inc. HLP Class I 1988-01-11
K873405 SUPERVISOR SUN GOGGLES(TM) Eye Communications, Inc. HQY Class I 1988-01-11
K874609 ZEISS VISULAS ARGON LASER Carl Zeiss, Inc. HQF Class II 1988-01-06
K874367 VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF Spembly Medical , Ltd. HQO Class II 1988-01-04
K873907 CONFIRMATION TESTS Richmond Products, Inc. HPC Class I 1987-12-29
K873908 H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. Richmond Products, Inc. HIT Class I 1987-12-23
K874057 OPHTHALMIC TIP & BLADE SCALPELS Myocure, Inc. HNN Class I 1987-12-23
K874220 OCS 100 (OCULAR COMPARATOR SYSTEM) Ocular Instruments, Inc. HJO Class II 1987-12-23
K874900 WOODLYN CLASSIC REFRACTOR, PHOROPTOR Woodlyn, Inc. HKN Class I 1987-12-23
K874963 MANUAL OPHTHALMIC SURGICAL INSTRUMENTS Solway, Inc. HNA Class I 1987-12-23
K874845 MALIS SURGICAL LOUPES Valley Forge Scientific Corp. HJH Class I 1987-12-23
K874056 OPHTHALMIC DISPOSABLE BLADES Myocure, Inc. HNN Class I 1987-12-22
K873914 ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) Richmond Products, Inc. HPL Class I 1987-12-11
K873916 'E' CUBE AND 'E' PAD Richmond Products, Inc. HOX Class I 1987-12-11
K874657 RIGID-LENS CASE Sola Ophthalmics LRX Class II 1987-12-08
K873911 PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 Richmond Products, Inc. HIT Class I 1987-12-02
K873913 COLOR BOOK ILLUMINATOR STAND Richmond Products, Inc. HJD Class I 1987-12-02
K873983 CAPTAIN POWER SUNGLASSES STYLES: #1020 #1021 Arcotoys, Inc. HQY Class I 1987-12-02
K874364 BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS Bausch & Lomb, Inc. LPN Class II 1987-11-25

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