meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
49
Latest Decision
1982-02-04

Clearances · page 46 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K813389 ULTRASONIC FRAGMENTOR Fibra Sonics, Inc. HQE Class II 1982-02-04
K813187 PILLING LACRIMAL INTUBATION SYSTEM Narco Scientific HNL Class I 1982-01-28
K813429 LASER PHOTOCOAGULATOR ARGON MED. LASER American Laser Corp. HPJ Class II 1982-01-22
K813481 OMS INFUSION CANNULA ASSEMBLE Optical Micro Systems, Inc. HMX Class I 1982-01-22
K813492 BRITT KRYPTON LASERS 150K & 152K Britt Corp., Inc. HQF Class II 1982-01-22
K813399 ERG-JET ELECTRODE Nicolet Biomedical Instruments HLZ Class II 1982-01-22
K813376 EYE CHARTS Abco Dealers, Inc. HOX Class I 1982-01-07
K813273 EMERGENCY POWER PAC (EMPAC) Optical Micro Systems, Inc. HKP Class II 1981-12-31
K813156 ULTRA-WIDE SAFETY SPECTACLE FRAME Zee Medical Products Co., Inc. HQZ Class I 1981-12-14
K812764 KOI BLUE FIELD ENTOPTOSCOPE Koi, Inc. HKL Class II 1981-12-02
K812896 I.V.E. REFRACTION SYSTEM Bausch & Lomb, Inc. HKO Class I 1981-12-02
K812949 RMI TRANSILLUMINATOR, MODEL 292 Radiation Measurements, Inc. HJM Class II 1981-12-02
K812331 VTS-1000 VISUAL TESTING SYSTEM Nicolet Biomedical Instruments HLX Class II 1981-11-16
K812706 MILLER/NADLER GLARE TESTER Mosebach Electric & Supply HOS Class I 1981-11-16
K812219 MODEL 900S INTRAOCULAR PROBE Lumenis, Inc. HQF Class II 1981-11-16
K812918 PILLING K KNIFE Narco Scientific HNN Class I 1981-11-06
K812620 ADJUSTABLE MICROSURGICAL KNIFE Vxtra Corp. HNN Class I 1981-10-19
K812723 PEARCE CORNEAL TREPHINE Visitec Co. HRH Class I 1981-10-13
K812441 DI-CROWN Coburn Optical Ind., Inc. HQG Class I 1981-10-06
K812544 RELIANCE OPHTHALMIC INSTRUMENT CONTROL F. & F. Koenigkramer HMF Class I 1981-09-21
K812450 KOI DIAMOND KNIFE Koi, Inc. HNN Class I 1981-09-21
K810876 SPECTACLE FRAMES Fashionline Corp. HQZ Class I 1981-09-21
K811718 SURFACE REPLACEMENT HIP PROSTHESIS Biomet, Inc. KYB Class I 1981-09-18
K812126 ULTRASONIC TIPS CooperVision, Inc. HQC Class II 1981-09-18
K812051 PHOTOLITE AOLITE TINTOMATIC LENS American Optical Corp. HQG Class I 1981-09-08
K811346 DICON AUTO PERIMETER 200 Dicon, Inc. HPT Class I 1981-08-20
K812255 ETHICON LACRIMAL STENT ETHICON, Inc. HNL Class I 1981-08-20
K811347 DICON AUTO PERIMETER 2000 Dicon, Inc. HPT Class I 1981-08-20
K812097 KOI LACREMAL HOOK & DILATOR Koi, Inc. HNW Class I 1981-08-18
K812063 SR-1V DATA PRINTER American Optical Corp. HKO Class I 1981-08-18
K811577 CROUCH CORNEAL PROTECTOR Denver Biomedicals, Inc. HOY Class I 1981-08-07
K811245 OPHTHALMIC SCISSORS Keeler Instruments, Inc. HNF Class I 1981-07-31
K812011 BLADE GAUGE Koi, Inc. HOE Class I 1981-07-28
K812010 KOI LACRIMAL INTUBATION SYSTEM Koi, Inc. HMX Class I 1981-07-28
K811554 BARNES-HIND SPECTACLE LENS CLEANER Barnes-Hind, Inc. HQG Class I 1981-07-02
K811108 RMI TRANSILLUMINATION LIGHT METER #295 Radiation Measurements, Inc. HJM Class II 1981-07-01
K811658 ANIS LENS IMPLANT FORCEPS #2 American V. Mueller HNR Class I 1981-06-26
K811455 ANIS GUIDING CANNULA American V. Mueller HMX Class I 1981-06-16
K811153 COHERENT FLOUROTRON MASTER Lumenis, Inc. HJO Class II 1981-06-16
K810699 PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM Visidyne Corp. HLX Class II 1981-06-09
K811180 ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ American Optical Corp. HOS Class I 1981-05-15
K810937 ANIS IRRIGATING SPATULA American V. Mueller HND Class I 1981-05-15
K810403 KEELER/KONAN SPECULAR MICROSCOPE Keeler Optical Products , Ltd. HJO Class II 1981-05-13
K802183 SR-IV PROGRAMMED SUBJECTIVE REFRACTOR American Optical Corp. HKO Class I 1981-04-23
K810013 MULTIPERFECTEMP CAUTERY Medical Products Development, Inc. HQP Class II 1981-04-23
K810817 EXETER OPERATING LOUPE Exeter Instruments, Inc. HOH Class I 1981-04-23
K802958 AUTO REFRACTOMETER NR-1000 Nippon Kogaku, Inc. HKO Class I 1981-04-23
K810016 REPLACABLE BATTERY PERFECTEMP CAUTERY Medical Products Development, Inc. HQP Class II 1981-04-23
K810012 MULTIMICRO SURGICAL CAUTERY Medical Products Development, Inc. HQP Class II 1981-04-23
K810700 CHROMOPS FM-100 COLOR VISION TESTER Visidyne Corp. HIT Class I 1981-04-10
K803308 FASHION SUNGLASSES Grand Imperial, Inc. HQY Class I 1981-04-03
K810278 EYEGLASS FRAMES Caesar Intl. Designs HQZ Class I 1981-04-03
K810152 X-VEE Temporaty Surgical Systems HKP Class II 1981-03-17
K803256 EYETECH-VISION SCREENING SYSTEM Eyedex HOX Class I 1981-03-04
K810098 FOX EYE SHIELDS American Hospital Supply Corp. HOY Class I 1981-02-27
K802082 POLARIS SPECTACLE FRAMES & LENSES Polaris Optics USA, Inc. HQY Class I 1981-02-13
K802971 LANDERS CONTACT LENS Cooper Medical Devices Corp. HJI Class I 1981-02-05
K802927 SEBESTYEN IRRIGATING CONTACT LENS Cooper Medical Devices Corp. HJI Class I 1981-02-05
K803159 AUTOMATED PERIMETERS Coburn Optical Ind., Inc. HPT Class I 1981-02-04
K803194 FISHER-PICKERING INTRAOCULAR EYE MAGNET Storz Instrument Co. HNR Class I 1981-02-04
K803195 SYSTEM 1 INSTRUMENT STAND Surgical Mechanical Research, Inc. HMF Class I 1981-02-04
K810017 MICROSURG CAUTERY Medical Products Development, Inc. HQO Class II 1981-01-05
K802794 PRO-OPHTA STICKS Secol Co. HOZ Class II 1980-12-22
K802332 INTRAJECT General Medical Engineering Corp. KYG Class I 1980-12-22
K802355 METRICON #120 FLUOROPHOTOMETER Metricon, Ltd. HJO Class II 1980-12-17
K802351 F110 PHOTO BINOCULAR OPHTHALMOSCOPE Minami, Tomine & Lew HLG Class I 1980-12-17
K802381 LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. Fibra Sonics, Inc. HQC Class II 1980-12-17
K802749 BLENDED BIFOCAL Robinson-Houchin, Inc. HQG Class I 1980-12-17
K802651 POSTOPERATIVE UV GLASSES (PLANO/APHAKIC) Chiron Vision Corp. HQG Class I 1980-12-17
K802845 CONCEPT CANALICULUS INTUBATION SET Concept, Inc. HNL Class I 1980-12-17
K802786 POROPLAST-EYE DRESSING Secol Co. HOY Class I 1980-12-17
K802770 FIBER OPTIC HEADLIGHT #60-0766766 Aspen Laboratories, Inc. FCT Class II 1980-12-11
K802769 FIBER OPTIC HEADLIGHT #60-0765 Aspen Laboratories, Inc. FCT Class II 1980-12-11
K802029 OBJECTIVE REFRACTOR Zeiss Humphrey System HKO Class I 1980-11-12
K802419 AO NON-CONTACT II TONOMETER American Optical Corp. HKX Class II 1980-11-12
K801922 TUTTIFRUTTI (NON-PRES. SUNGLASSES) Safety Plastics of New York HQY Class I 1980-11-12
K801822 NU-VISION DISP. OPHTHALMIC DRESSING TRAY Summit Optics, Inc. KYG Class I 1980-09-30
K801767 DIMENSION I REFRACTION SYSTEM Smr HLM Class I 1980-09-16
K801733 FENZL RETICLE Robert E. Fenzl, M.D. HOI Class I 1980-09-16
K801850 CHARLES PNEUMATIC INTRAOCULAR SCISSORS Cooper Medical Devices Corp. HQE Class II 1980-09-16
K801877 SLIT LAMP ATTACHMENT Cavitron Corp. HQB Class II 1980-09-16
K801937 BLEPHAROMETER Aztec Medical Products, Inc. HOE Class I 1980-09-16
K801659 BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE Coburn Optical Ind., Inc. HJO Class II 1980-09-09
K801906 DIOPTRON III AUTOREFRACTOR Coherent Medical Division HKO Class I 1980-08-27
K801969 ASNIS GUIDED SCREW SYSTEMS Howmedica Corp. HNC Class I 1980-08-27
K801609 MADDOX LENS SPATULA CAT. #7245 Edward Weck, Inc. HND Class I 1980-08-13
K801638 A O CUSTOM II CHAIR AND STAND American Optical Corp. HME Class I 1980-08-13
K801608 MCCULLEY CONTINUOUS SUTURE TIGHTNER Edward Weck, Inc. HND Class I 1980-08-12
K801554 STERILE CAST PADDING Medi-Spec HIX Class I 1980-08-04
K801518 SPAN-AID BRIDGING PILLOW SYSTEM Span-America Medical Systems, Inc. HKX Class II 1980-08-04
K801467 DODICK LENS HOLDING FORCEPS Edward Weck, Inc. HNR Class I 1980-07-28
K801465 GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE Edward Weck, Inc. HNR Class I 1980-07-28
K801469 BONN MICRO IRIS HOOK (NON-STERILE) #7613 Edward Weck, Inc. HNQ Class I 1980-07-28
K801381 FITE FIXATION TOY FOR OCULAR EXAM Fite Engineering Corp. HPL Class I 1980-07-28
K801466 LEIGH MEASURING SCALE #7725 Edward Weck, Inc. HLN Class I 1980-07-28
K801336 MODEL 900K PHOTOCOAGULATOR Coherent Medical Division HQF Class II 1980-07-28
K801231 EYE-VAC Coburn Optical Ind., Inc. HKP Class II 1980-07-21
K801418 KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT Keeler Optical Products , Ltd. HPS Class II 1980-07-21
K801411 MAY ILLUMINATED/INFUSION PIC Cooper Medical Devices Corp. HMX Class I 1980-07-21
K801232 JACKSON LACRIMAL INTUBATION SET Storz Instrument Co. HNL Class I 1980-06-17

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