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
107065–107088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1994
SUNGLASSES
K941148 · HQY
Metal Dream S.R.L.
Ophthalmic · 147d
Cleared Aug 04, 1994
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
K942104 · HLI
Keeler Instruments, Inc.
Ophthalmic · 94d
Cleared Aug 04, 1994
SAF-GEL HYDRATING DERMAL WOUND DRESSING
K942270 · KMF
Calgon Vestal Div.
General & Plastic Surgery · 86d
Cleared Aug 04, 1994
PERSOL, MOSCLHINO, AND GERALD GENTA
K942845 · HQZ
Persol America, Inc.
Ophthalmic · 49d
Cleared Aug 04, 1994
SPECTACLE FRAME
K943082 · HQZ
Daewon Optical Co.
Ophthalmic · 37d
Cleared Aug 04, 1994
SPECTACLE FRAME
K943085 · HQZ
Winntics Optical Industry Co. , Ltd.
Ophthalmic · 37d
Cleared Aug 04, 1994
INTRA-SONIX UROFIBER
K943117 · GCJ
Intra-Sonix, Inc.
General & Plastic Surgery · 38d
Cleared Aug 04, 1994
ORVIS DRIVING GLASSES
K943161 · HQY
The Orvis Co., Inc.
Ophthalmic · 34d
Cleared Aug 04, 1994
CIBA VISION(R) CONTACT LENS CASE
K943183 · LRX
Ciba Vision Corporation
Ophthalmic · 34d
Cleared Aug 04, 1994
HYDROCOLLOID WOUND DRESSING
K943258 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 29d
Cleared Aug 04, 1994
EVERYTHING KIDS
K943328 · HQY
Jcc Co., Inc.
Ophthalmic · 23d
Cleared Aug 03, 1994
INSTA-NERVE(TM) NERVE CONDUCTION MONITOR
K935298 · JXE
Insta Nerve Canada, Inc.
Neurology · 274d
Cleared Aug 03, 1994
K-KLIP
K940801 · DRX
Katecho, Inc.
Cardiovascular · 162d
Cleared Aug 03, 1994
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684 · FPB
Abbott Laboratories
General Hospital · 121d
Cleared Aug 03, 1994
SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG
K941869 · KZF
The Lighthouse For the Blind, Inc.
General Hospital · 107d
Cleared Aug 03, 1994
PULSEJET DENTAL LASER SYSTEM
K942217 · GEX
Incisive Technologies, Inc.
General & Plastic Surgery · 89d
Cleared Aug 03, 1994
LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS
K942692 · EFQ
Lorons International Corp.
General & Plastic Surgery · 57d
Cleared Aug 03, 1994
LORREX IV SPONGES, STERILE 2'S
K942824 · EFQ
Lorrex Health Products
General & Plastic Surgery · 50d
Cleared Aug 03, 1994
NEURO-AIDE
K942926 · GWY
Burke Neutech, Inc.
Neurology · 42d
Cleared Aug 03, 1994
DISPOSABLE BIPOLAR ELECTRODE
K942955 · GWG
Neuro Navigational Corp.
Neurology · 41d
Cleared Aug 03, 1994
LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'S
K943184 · EFQ
Lorons International Corp.
General & Plastic Surgery · 33d
Cleared Aug 03, 1994
CORASSIST WOUND DRESSING
K943364 · KMF
Calgon Corp.
General & Plastic Surgery · 21d
Cleared Aug 02, 1994
BRANEMARK SYSTEM TEMPORARY SOLUTIONS
K925766 · DZE
Nobelpharma USA, Inc.
Dental · 624d
Cleared Aug 02, 1994
AKCESS0CATH KIT
K925819 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 623d