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
4369–4392 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 05, 1985
ACC CROSS CYLINDERS
K852056 · HPC
Ascon Medical Instruments, Ltd.
Ophthalmic · 27d
Cleared Jun 05, 1985
ATF 101 TRAIL FRAME
K852126 · HPA
Ascon Medical Instruments, Ltd.
Ophthalmic · 21d
Cleared Jun 03, 1985
INTEGRITY EYE DROP GUIDE
K851908
Integrity Optics, Inc.
Ophthalmic · 33d
Cleared May 31, 1985
CILCO/UNITED SONICS PHACE PF-9000
K851209 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
UNITED SONICS PHACO MODULE, DF-35
K851210 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
UNITED SONICS PACO SYSTEM MODEL 3000
K851212 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
MID LABS MVSXI
K851298 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 30, 1985
SPECTACLE FRAME
K851130 · HQZ
New Brillette A/S
Ophthalmic · 70d
Cleared May 30, 1985
SUNGLASES
K851163 · HQG
Full See Glasses Ind. Co., Ltd.
Ophthalmic · 69d
Cleared May 30, 1985
ANESTHESIOMETER
K851557 · HJC
Luneau SA
Ophthalmic · 44d
Cleared May 30, 1985
SOLEX & SAXON INT'L OPTICAL OF HONG KONG
K851661 · HQZ
South West Intl., Inc.
Ophthalmic · 37d
Cleared May 30, 1985
37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS
K851791 · HNR
Artiberia
Ophthalmic · 35d
Cleared May 30, 1985
37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS
K851792 · HNR
Artiberia
Ophthalmic · 35d
Cleared May 30, 1985
ON TARGET
K851887 · HPX
Newman Assoc.
Ophthalmic · 29d
Cleared May 23, 1985
OPTHALMIC BAR PRISM
K851555 · HKW
Roseburg SA
Ophthalmic · 37d
Cleared May 23, 1985
37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN
K851790 · HNN
Artiberia
Ophthalmic · 28d
Cleared May 22, 1985
AMPCO OPTHALMIC TRAY
K842983 · HOZ
Associated Medical Products Co.
Ophthalmic · 296d
Cleared May 22, 1985
EYE PROCEDURE PACK
K850340 · HOZ
Marwood Medical, Inc.
Ophthalmic · 114d
Cleared May 21, 1985
ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT
K850649
Lacrimedics, Inc.
Ophthalmic · 91d
Cleared May 16, 1985
SYSTEM 930 ARGON PHOTOCOAGULATOR
K844356 · HQB
Coherent Medical Group
Ophthalmic · 188d
Cleared May 16, 1985
MARLIN CONTACT LENS CASE
K851497 · HPX
Marlin Industries
Ophthalmic · 31d
Cleared May 10, 1985
PRE-OPERATIVE OPHTHALMIC DRESSING TRAY
K842601 · HOZ
Ophthalmic Resources, Inc.
Ophthalmic · 309d
Cleared May 09, 1985
CATARACT TRAY
K842647 · HNN
Deroyal Industries, Inc.
Ophthalmic · 303d
Cleared May 09, 1985
STERILE EYE SURGERY KITS
K842990 · HOZ
Biological & Environmental Control...
Ophthalmic · 283d