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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142297–142320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1986
FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA
K862444 · HHR
Laser Media
Obstetrics & Gynecology · 91d
Cleared Sep 25, 1986
EXEL THREE-WAY STOPCOCK
K862492 · FMG
Exel Intl.
General Hospital · 86d
Cleared Sep 25, 1986
RABINOWITZ GUM MASSAGER
K862635 · JEW
Arnell, Inc.
Dental · 77d
Cleared Sep 25, 1986
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879 · ELW
Dentsply Intl.
Dental · 57d
Cleared Sep 25, 1986
THE BIO-TEK UW-II
K862932 · IMJ
Bio-Tek Instruments, Inc.
Physical Medicine · 52d
Cleared Sep 25, 1986
CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES
K862952 · HPX
Paco Pharmaceutical Services, Inc.
Ophthalmic · 51d
Cleared Sep 25, 1986
METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
K862955 · KLS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 51d
Cleared Sep 25, 1986
MERIVAARA PATIENT TROLLEY - MODEL #416
K862959 · FPO
Global Medical Prods, Inc.
General Hospital · 51d
Cleared Sep 25, 1986
FREE T3 RADIOIMMUNOASSAY KIT
K862968 · KHQ
Bioclinical Group
Chemistry · 50d
Cleared Sep 25, 1986
GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX
K863009 · EJP
Sds Dental, Inc.
Dental · 48d
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