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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
142897–142920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1986
ISOLAX (GNATUS)/ISOLAX PEDAL/MINILAX
K863017
Sds Dental, Inc.
Dental · 48d
Cleared Sep 25, 1986
DENTATUS-S / L / LS / (GNATUS)
K863018
Sds Dental, Inc.
Dental · 48d
Cleared Sep 25, 1986
CABINET II AUXILIARY UNIT
K863023 · EIA
Sds Dental, Inc.
Dental · 48d
Cleared Sep 25, 1986
SERINGA TRIPLICE S.L.
K863024 · ECB
Sds Dental, Inc.
Dental · 48d
Cleared Sep 25, 1986
CHOLESTEROL-E (TOTAL)
K863062 · CHH
J. D. Assoc.
Chemistry · 44d
Cleared Sep 25, 1986
HDL CHOLESTEROL-E
K863065
J. D. Assoc.
Chemistry · 44d
Cleared Sep 25, 1986
ABBOTT SPECTRUM PHOSPHORUS REAGENT
K863088 · CEO
Abbott Laboratories
Chemistry · 43d
Cleared Sep 25, 1986
HIGH PERFORMANCE CANNABINOID CONTROLS
K863117 · LAS
Rapid Diagnostic Laboratories, Inc.
Toxicology · 42d
Cleared Sep 25, 1986
PROPHY CARE PASTE
K863133 · EJR
Imd, Inc.
Dental · 41d
Cleared Sep 25, 1986
RESTODENT POSTERIOR
K863157 · EBF
Lee Pharmaceuticals
Dental · 41d
Cleared Sep 25, 1986
HPL RIA KIT
K863188 · JMX
Biotecx Laboratories, Inc.
Chemistry · 37d
Cleared Sep 25, 1986
SURGICAL IOP MONITOR
K863235 · HKX
Ameritek, Inc.
Ophthalmic · 35d
Cleared Sep 25, 1986
MODIFICATION'S TO TORAY'S B-2 SERIES
K863297 · FJT
National Medical Care, Medical...
Gastroenterology & Urology · 31d
Cleared Sep 25, 1986
IMMOBILIZING VACUUM MATRESS (IVM)
K863511 · FPP
Omnium Services Partners, Inc.
General Hospital · 16d
Cleared Sep 25, 1986
PROMEDICOR
K863514 · FMI
Terra Marketing Assoc.
General Hospital · 16d
Cleared Sep 25, 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 13d
Cleared Sep 25, 1986
DISSCAP 80E, 110E, 140E, 160E
K863592 · FJI
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Sep 25, 1986
AMERICAN EDWARDS 4.0 MM ARTHROSCOPE
K863597 · HRX
American Edwards Laboratories
Orthopedic · 10d
Cleared Sep 25, 1986
KNIFE MAKER
K863616 · IDL
Surgipath Medical Industries, Inc.
Pathology · 9d
Cleared Sep 25, 1986
SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000
K863645 · HFW
United Medical Systems, Inc.
Obstetrics & Gynecology · 7d
Cleared Sep 25, 1986
OPHTHALMIC SURGICAL SPECULUM
K863664 · HNC
Myocure, Inc.
Ophthalmic · 7d
Cleared Sep 25, 1986
THE ULTIMATE
K863665 · HNN
Myocure, Inc.
Ophthalmic · 7d
Cleared Sep 24, 1986
MODIFIED CARDIOCAP MONITOR
K862455 · DSK
Datex Division Instrumentarium Corp.
Cardiovascular · 89d
Cleared Sep 24, 1986
BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE
K862937 · DQX
Versaflex Delivery Systems, Inc.
Cardiovascular · 51d