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

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176,076 results
164377–164400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1981
HUMAN IGG-ALBUMIN TEST KIT
K811178 · CJQ
Meloy Laboratories, Inc.
Chemistry · 17d
Cleared May 15, 1981
OSMOMETER MODEL OM-6010
K811179 · JJM
Fiske Med Science
Chemistry · 17d
Cleared May 15, 1981
ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ
K811180 · HOS
American Optical Corp.
Ophthalmic · 17d
Cleared May 15, 1981
MULTIANALYTE CONTROLS, ALL KINDS
K811182 · JJY
Fisher Scientific Co., LLC
Chemistry · 17d
Cleared May 15, 1981
NORELCO BLOOD PRESSURE METER
K811188 · DXN
North American Philips Corp.
Cardiovascular · 16d
Cleared May 13, 1981
KEELER/KONAN SPECULAR MICROSCOPE
K810403 · HJO
Keeler Optical Products , Ltd.
Ophthalmic · 84d
Cleared May 13, 1981
PHADEBAS ISOAMYLASE TEST
K810584 · CIW
Pharmacia, Inc.
Chemistry · 70d
Cleared May 13, 1981
K-MED ENCOURAGER INCENTIVE SPIROMETER
K810641 · BWF
K-Med, Inc.
Anesthesiology · 64d
Cleared May 13, 1981
MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS
K810768 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE
K810769 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
MED. 199(MODIFIED) W/HANKS' SALTS
K810770 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
L-15 MEDIUM (MODIFIED)
K810771 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE
K810772 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
BASAL MEDIUM EAGLE W/HANKS' SALTS
K810773 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
WATER-TISSUE CULTURE GRADE
K810774 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
PENICILLIN-STREPTOMYCIN MIXTURE
K810776 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT
K810778 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
EARLE'S BALANCED SALTS SOULTION
K810779 · KIP
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
SODIUM BICARBONATE (7.5%) SOLUTION
K810780 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
L-GLUTAMINE
K810781 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
TRYPAN BLUE (0.5% IN NORMAL SALINE)
K810782 · LGY
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
ALSEVER'S SOLUTION (MODIFIED)
K810783 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
XIMATRON V
K810858 · KPQ
Siemens Corp.
Radiology · 44d
Cleared May 13, 1981
ARALUEN HEAD SHIELD
K810868 · FPP
Araluen, Inc.
General Hospital · 43d