FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
107041–107064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-123
K942711 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A
K942712 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H
K942713 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP
K942714 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC
K942715 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A
K942717 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
K942719 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-12
K942720 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13
K942721 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
SUNGLASSES
K942754 · HQY
Kimball Corp.
Ophthalmic · 56d
Cleared Aug 05, 1994
SELF SUPER MAXI SNAITARY NAPKINS
K942814 · HHD
Kegan & Kegan, Ltd.
Obstetrics & Gynecology · 51d
Cleared Aug 05, 1994
OPTHALMIC WIPE
K942897 · HQZ
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 46d
Cleared Aug 05, 1994
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K942972 · LYZ
Lcl Taiwan & Co., Ltd.
General Hospital · 46d
Cleared Aug 05, 1994
SPECTACLE FRAMES
K943198 · HQZ
Lunettes Folomi S.A.
Ophthalmic · 31d
Cleared Aug 05, 1994
N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO
K943265 · HQZ
The First Optical Manufactory , Ltd.
Ophthalmic · 29d
Cleared Aug 05, 1994
SPOMA INTERNATIONAL CORPORATION
K943352 · HQY
Spoma Intl. Corp.
Ophthalmic · 24d
Cleared Aug 05, 1994
RIGHT ANGLE UROLOGIC LASER FIBER
K943491 · GEX
Surgitek
General & Plastic Surgery · 17d
Cleared Aug 05, 1994
WINK EYEWEAR
K943507 · HQZ
Wink Optical, Inc.
Ophthalmic · 16d
Cleared Aug 05, 1994
7300 NASAL CPAP SYSTEM
K943509 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 16d
Cleared Aug 04, 1994
SPINE-TECH CERVICAL FIXATION SYSTEM
K931653 · KWQ
Spinal Technologies
Orthopedic · 486d
Cleared Aug 04, 1994
SPECTACLE FRAMES, SUNGLASSES
K936125 · HQY
Eyedesigns Corp.
Ophthalmic · 224d
Cleared Aug 04, 1994
MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE
K940088 · HQC
Medical Technical Products
Ophthalmic · 209d
Cleared Aug 04, 1994
SUNGLASSES
K940561 · HQY
Hibiscus Ind. Co. , Ltd.
Ophthalmic · 178d
Cleared Aug 04, 1994
EARCRAFT HEARING AID
K940670 · ESD
Earcraft, Inc.
Ear, Nose, Throat · 169d