FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
3865–3888 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 24, 1988
MOBAY (BAYER) MERLON M-40 (H)F 1112
K873822 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
MOBAY (BAYER) MAKROLON 2658 3291
K873823 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000
K873824 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
GE LEXAN 144R 112
K873825 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 21, 1988
HEALTH CARE EYE PROTECTION
K875107 · HOY
Surgikos, Inc.
Ophthalmic · 98d
Cleared Mar 21, 1988
MEDICAL EYE DISPOSABLE SHIELD
K875302 · HOY
Bfd, Inc.
Ophthalmic · 83d
Cleared Mar 17, 1988
OPTEC 1000 DMV VISION TESTER MODIFY
K875237 · HOX
Stereo Optical Co., Inc.
Ophthalmic · 86d
Cleared Mar 08, 1988
MENTOR B-VAT(TM) II VIDEO TESTER
K875112 · HOX
Mentor O & O, Inc.
Ophthalmic · 84d
Cleared Mar 07, 1988
DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0
K873853 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 167d
Cleared Mar 07, 1988
C-MATE #CMU 1001
K880062 · HQC
O.R. Specialties, Inc.
Ophthalmic · 60d
Cleared Feb 26, 1988
SUNGLASSES (NONPRESCRIPTION)
K873966 · HQY
Swank Plus , Ltd.
Ophthalmic · 150d
Cleared Feb 26, 1988
SPECTACLE, MAGNIFYING
K873967 · HOT
Swank Plus , Ltd.
Ophthalmic · 150d
Cleared Feb 26, 1988
LABTICIAN RETINAL IMPLANTS
K875014 · HQJ
Labtician Products, Inc.
Ophthalmic · 84d
Cleared Feb 26, 1988
HOSKINS-BARKAN GONIOTOMY LENS 10MM
K875330 · HJK
Ocular Instruments, Inc.
Ophthalmic · 58d
Cleared Feb 26, 1988
BICONCAVE VITRECTOMY LENS
K875331 · HJK
Ocular Instruments, Inc.
Ophthalmic · 58d
Cleared Feb 22, 1988
SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.
K875063 · HQG
Epson EL Paso, Inc.
Ophthalmic · 75d
Cleared Feb 19, 1988
HOLLYWOODS COOL SHADES
K874722 · HQY
Tonka Corp.
Ophthalmic · 93d
Cleared Feb 19, 1988
PEYMAN G. 12.12 YAG LASER LENS
K875087 · HJK
Ocular Instruments, Inc.
Ophthalmic · 72d
Cleared Feb 19, 1988
HOSKINS-BARKAN GONIOTOMY LENS 9MM
K875114 · HJK
Ocular Instruments, Inc.
Ophthalmic · 67d
Cleared Feb 19, 1988
LOW-POWER BINOCULAR LOUPE
K875124 · HOH
Seiler Instrument & Mfg. Co., Inc.
Ophthalmic · 66d
Cleared Feb 09, 1988
OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE
K875197 · LRX
Pro-Optics, Inc.
Ophthalmic · 54d
Cleared Feb 05, 1988
IRAS EDS INTERFEROMETRIC STIMULATOR
K873990 · HLX
Randwal Instrument Co., Inc.
Ophthalmic · 127d
Cleared Feb 05, 1988
SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES
K874681 · HQG
Klockner Contract Packaging, Inc.
Ophthalmic · 84d
Cleared Feb 05, 1988
ANOMALOSCOPE PLATE TEST - 5 [APT-5]
K875026 · HIT
Lkc Technologies, Inc.
Ophthalmic · 60d