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
4345–4368 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 08, 1985
SUNNY SUN MAGNIFYING GLASSES
K852830 · HQY
Sunny Optical Co., Ltd.
Ophthalmic · 37d
Cleared Aug 08, 1985
PRECISION - COSMET CAPSULE COUPEUR
K852934 · HNY
Precision-Cosmet Co., Inc.
Ophthalmic · 30d
Cleared Aug 06, 1985
BEAVER MULTIPURPOSE SAPPHIRE KNIFE
K853129 · HNN
Rudolph Beaver, Inc.
Ophthalmic · 11d
Cleared Aug 05, 1985
PHAKOSYSTEMS MODEL CES 4100
K851674 · HQC
Phakosystems, Inc.
Ophthalmic · 104d
Cleared Aug 01, 1985
PERMALID PAK
K842781
CooperVision, Inc.
Ophthalmic · 381d
Cleared Aug 01, 1985
PERMALID LINER PAK
K842814
CooperVision, Inc.
Ophthalmic · 379d
Cleared Aug 01, 1985
MDS 83 OPHTHALMIC DYE LASER SYSTEM
K852234 · HQF
Meditec, Inc.
Ophthalmic · 71d
Cleared Aug 01, 1985
INFUSION CANNULAM
K852758 · HMX
Precision Medical Instruments, Inc.
Ophthalmic · 34d
Cleared Jul 31, 1985
ULTRATHIN/SP LENS
K843957 · HRG
Optical Systems Intl., Inc.
Ophthalmic · 294d
Cleared Jul 31, 1985
ANNE MARIE PERRIS SUNGLASSES AND FRAMES
K851698 · HQY
Perlinea Co.
Ophthalmic · 98d
Cleared Jul 31, 1985
SITE INFUSION CONTACT LENS W/ILLUMINATOR
K852187
Microsurgical Systems, Inc.
Ophthalmic · 72d
Cleared Jul 31, 1985
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
K852384 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 56d
Cleared Jul 31, 1985
ATL 225 MW TRAIL LENS SET
K852548 · HPA
Ascon Medical Instruments, Ltd.
Ophthalmic · 49d
Cleared Jul 25, 1985
HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.
K852464 · HQF
Hcg, Inc.
Ophthalmic · 45d
Cleared Jul 22, 1985
MACULAR FUNCTION ANALYZER
K843227 · HOQ
Danek Medical, Inc.
Ophthalmic · 340d
Cleared Jul 22, 1985
COMBINED MVS SYSTEMS
K851610 · HQE
Medical Instrument Development...
Ophthalmic · 98d
Cleared Jul 05, 1985
VERSAPHAGE
K851272 · HQE
Alphamedix, Inc.
Ophthalmic · 95d
Cleared Jun 27, 1985
ASCON SURGICAL INSTRUMENTS
K852057 · HNR
Ascon Medical Instruments, Ltd.
Ophthalmic · 49d
Cleared Jun 24, 1985
OMS SILICONE OIL INJECTOR
K844895 · LWL
Optical Micro Systems, Inc.
Ophthalmic · 189d
Cleared Jun 20, 1985
13-550,13-560 WESCOTT SCOSSORS (EYE)
K851768 · HNF
Artiberia
Ophthalmic · 56d
Cleared Jun 18, 1985
MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)
K852334 · HLJ
Design Med. Corp.
Ophthalmic · 18d
Cleared Jun 07, 1985
STERILE EYE PACKS OR TRAYS
K852229
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 16d
Cleared Jun 05, 1985
SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR
K844357 · HQF
Coherent Medical Group
Ophthalmic · 208d
Cleared Jun 05, 1985
PHACO PAK I
K851211 · HQC
United Sonics, Inc.
Ophthalmic · 71d