Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ophthalmic ×
5,119 results
1969–1992 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 04, 1998
PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM
K974203 · MQU
Integrated Orbital Implants, Inc.
Ophthalmic · 86d
Cleared Feb 04, 1998
PARAGON LENS CARE
K974635 · LRX
Paragon Vision Sciences
Ophthalmic · 54d
Cleared Jan 30, 1998
NON-PRESCRIPTION SUNGLASSES
K974852 · HQY
Chia Hui Spectacles Mfg. Corp.
Ophthalmic · 32d
Cleared Jan 30, 1998
NON-PRESCRIPTION SUNGLASSES
K974860 · HQY
Wenzhou Ming Ming Optical Co. , Ltd.
Ophthalmic · 32d
Cleared Jan 27, 1998
NON-PRESCRIPTION SUNGLASSES
K974861 · HQY
Wenzhou Hindar Optical Co., Ltd.
Ophthalmic · 29d
Cleared Jan 23, 1998
HYDROBRUSH (TM) KERATOME
K971078 · HQS
Medjet, Inc.
Ophthalmic · 305d
Cleared Jan 20, 1998
MEDPOR OCULAR CONFORMER
K972034 · HQN
Porex Surgical, Inc.
Ophthalmic · 232d
Cleared Jan 20, 1998
KERATOME SYSTEM
K974243 · HMY
Insight Technologies Instruments, LLC
Ophthalmic · 69d
Cleared Jan 20, 1998
ALCON CONTACT LENS CASE
K974281 · LRX
Alcon Laboratories
Ophthalmic · 67d
Cleared Jan 20, 1998
PHACOPAK
K974719 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 33d
Cleared Jan 16, 1998
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
K973633 · OKS
Atrion Medical Products, Inc.
Ophthalmic · 183d
Cleared Jan 12, 1998
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
K973921 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 89d
Cleared Jan 12, 1998
SUNGLASSES
K974511 · HQY
Sun World Intl., Inc.
Ophthalmic · 42d
Cleared Jan 09, 1998
SUNGLASSES
K974441 · HQY
Hip Shing Fat Co., Ltd.
Ophthalmic · 45d
Cleared Jan 08, 1998
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
K973872 · OKS
Atrion Medical Products, Inc.
Ophthalmic · 90d
Cleared Jan 08, 1998
AUTOMATED DISPOSABLE KERATOME (ADK)
K974004 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 79d
Cleared Dec 19, 1997
PREFERENCE 60 AND PREFERENCE 60 TORIC
K963013 · LPL
CooperVision, Inc.
Ophthalmic · 507d
Cleared Dec 17, 1997
MPORT FOLDABLE LENS PLACEMENT SYSTEM
K970727 · MSS
Chiron Vision Corp.
Ophthalmic · 292d
Cleared Dec 17, 1997
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K971242 · MML
Ipax, Inc.
Ophthalmic · 259d
Cleared Dec 17, 1997
ULTRACELL SUCTION SPONGE
K972633 · HOZ
Ultracell Medical Technologies, Inc.
Ophthalmic · 156d
Cleared Dec 16, 1997
OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
K973552 · MTZ
Bio-Vascular, Inc.
Ophthalmic · 88d
Cleared Dec 12, 1997
RETINAL CUBE
K973950 · HKI
Applied Spectral Imaging , Ltd.
Ophthalmic · 57d
Cleared Dec 08, 1997
SUNGLASSES
K973528 · HQY
Jeou Jeou Long Industrial Co., Ltd.
Ophthalmic · 82d
Cleared Dec 08, 1997
FRAG COMMANDER
K973749 · HQC
Scieran Technologies, Inc.
Ophthalmic · 68d