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
4513–4536 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 11, 1984
AXIPAC II
K834539
Teknar, Inc.
Ophthalmic · 272d
Cleared Aug 15, 1984
COLOR OPTIC CORNEAL EYE SHIELD
K840414 · HOY
Diversations, Inc.
Ophthalmic · 197d
Cleared Aug 15, 1984
ACU220 CRYO UNIT
K841294 · HQA
Keller Instruments, Inc.
Ophthalmic · 139d
Cleared Aug 15, 1984
AMER. MEDICAL OPTICS ARGON/KRYPTON LASE
K842250 · HQF
American Medical Optics
Ophthalmic · 77d
Cleared Aug 15, 1984
AMERI. MEDICAL OPTICS ARGON LASER PHOTO
K842251 · HQF
American Medical Optics
Ophthalmic · 77d
Cleared Aug 15, 1984
SITE SIMCOE STYLE I/A HANDPIECE
K842458 · HQC
Chiron Vision Corp.
Ophthalmic · 54d
Cleared Aug 15, 1984
SITE GILLS STYLE I/A HANDPIECE
K842459
Chiron Vision Corp.
Ophthalmic · 54d
Cleared Aug 15, 1984
PORTABLE ACUIOMETER
K842567 · HLJ
Randwal Instrument Co., Inc.
Ophthalmic · 44d
Cleared Aug 07, 1984
WOODLYN CLASSIC SLIT LAMP HSSL-CL
K841761 · HLI
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN CLASSIC JAVAL OPHTHALMOMETER
K841764 · HLI
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN STANDARD SLIT LAMP HSSL-ST
K841765 · HLQ
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN CLASSIC KERATOMETER
K841767 · HLI
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
AMERICAN MEDICAL OPTICS PHOTOKERATO
K842128 · HJA
American Medical Optics
Ophthalmic · 70d
Cleared Aug 07, 1984
ROOTMAN ORBITAL SURGERY INSTRUMENT SET
K842697 · HNR
Downs Surgical , Ltd.
Ophthalmic · 27d
Cleared Aug 02, 1984
WOODLYN APPLANATION TONOMETER
K841762 · HKX
Woodlyn, Inc.
Ophthalmic · 97d
Cleared Aug 02, 1984
WOODLYN SLIT LAMP HSSL-EC
K841763 · HLI
Woodlyn, Inc.
Ophthalmic · 97d
Cleared Jul 27, 1984
SUNGLASSES
K841248 · HQG
China Toy & Novelty Co., Ltd.
Ophthalmic · 150d
Cleared Jul 12, 1984
GENERATED RETINAL REFLEX IMAGERY SYS
K840840 · HKM
Electro Optical Instruments
Ophthalmic · 139d
Cleared Jul 09, 1984
SILA CLEAN 20/20
K832327
Professional Supplies, Inc.
Ophthalmic · 360d
Cleared Jun 26, 1984
MODEL 4000 MD-YAG LASER FOR MALIGNANT
K842412 · HQF
Cooper Lasersonics, Inc.
Ophthalmic · 7d
Cleared Jun 19, 1984
UNIVERSAL PACK
K834155 · HQE
Atlantic Optical Systems, Inc.
Ophthalmic · 200d
Cleared Jun 19, 1984
MANUAL IRRIGATING/ASPIRATING UNIT
K840495 · HQC
Alltek, Inc.
Ophthalmic · 134d
Cleared Jun 19, 1984
CAT 100
K840836 · HKX
CooperVision, Inc.
Ophthalmic · 116d
Cleared Jun 19, 1984
OCTOPUS 500/500E
K841099 · HPT
Cilco, Inc.
Ophthalmic · 99d