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
2305–2328 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 04, 1996
ARNET OR ARNETTE
K960530 · HQY
Arnet Optic Illusions
Ophthalmic · 27d
Cleared Mar 04, 1996
LANARD, RADIO SHADES, SUN SHADES, COOL SHADES, KOOL LOOPS, SOLAR SPEX, SHADE...
K960628 · HQY
Lanard Toys, Ltd.
Ophthalmic · 20d
Cleared Feb 16, 1996
JAMES KOREA OPTICAL FRAMES & SUNGLASSES
K960289 · HQY
James Korea Co., Ltd.
Ophthalmic · 25d
Cleared Feb 14, 1996
DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K953807 · LPL
Stephen A. Dunn, Inc.
Ophthalmic · 190d
Cleared Feb 12, 1996
MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM
K955245 · HQC
Mentor O & O, Inc.
Ophthalmic · 89d
Cleared Feb 09, 1996
SURGITRON
K955158 · HQR
Ellman Intl., Inc.
Ophthalmic · 88d
Cleared Jan 29, 1996
ZONG RONG SUNGLASSES
K955287 · HQY
Yuu Yeng Enterprise Co., Ltd.
Ophthalmic · 73d
Cleared Jan 29, 1996
ZONG RONG SUNGLASSES
K955441 · HQY
Zong Rong Glasses Ltd. Co.
Ophthalmic · 69d
Cleared Jan 29, 1996
PLASTIC FRAME, METAL FRAME, OPTICAL
K955695 · HQY
Dah Sing Trading Co.
Ophthalmic · 47d
Cleared Jan 25, 1996
MEDPOR OCULAR SCREW & ACCESSORIES
K954939 · HPZ
Porex Surgical, Inc.
Ophthalmic · 87d
Cleared Jan 11, 1996
MOONSHADES SUNGLASSES
K954659 · HQY
Blublocker Corp.
Ophthalmic · 93d
Cleared Jan 11, 1996
PHACO TIP
K954746 · HQC
U.S. Iol, Inc.
Ophthalmic · 87d
Cleared Jan 11, 1996
SUNGLASSES WITH IMPACT RESISTANT LENSES
K955572 · HQY
Diamond Mark International Co., Ltd.
Ophthalmic · 35d
Cleared Jan 05, 1996
GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
K952569 · HQR
Gamp & Assoc.
Ophthalmic · 214d
Cleared Jan 05, 1996
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR
K952581 · MPA
Gamp & Assoc.
Ophthalmic · 214d
Cleared Jan 05, 1996
GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR
K952585 · MPA
Gamp & Assoc.
Ophthalmic · 214d
Cleared Jan 04, 1996
DURASOFT FRESHLOOK UV COLORS
K954603 · LPL
Wesley Jessen Corp.
Ophthalmic · 92d
Cleared Jan 03, 1996
OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
K952260 · HQD
Stellar Contact Lens, Inc.
Ophthalmic · 233d
Cleared Jan 03, 1996
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
K955442 · HKI
Kowa Optimed, Inc.
Ophthalmic · 36d
Cleared Jan 03, 1996
UNISUN
K955539 · HQY
Steven Chen
Ophthalmic · 29d
Cleared Jan 03, 1996
KMANZ II
K955611 · HQY
Gatorz LLC
Ophthalmic · 26d
Cleared Dec 26, 1995
RM001 REUSABLE
K953538 · HQC
American Optisurgical, Inc.
Ophthalmic · 151d
Cleared Dec 26, 1995
DM001 DISPOSABLE PACK
K953539 · HQC
American Optisurgical, Inc.
Ophthalmic · 151d
Cleared Dec 22, 1995
GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE
K954306 · HQB
Gamp & Assoc.
Ophthalmic · 98d