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
173017–173040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1977
SILICONE IMPRESSION MATEOIAL
K771248 · ELW
Interstate Dental Co., Inc.
Dental · 4d
Cleared Jul 15, 1977
JOY LIGHT
K771249 · EAZ
M.D. Intl., Inc.
Dental · 8d
Cleared Jul 15, 1977
HU:500, HYGIENASSIST
K771251 · EIA
Litton Dental Products
Dental · 4d
Cleared Jul 15, 1977
CB600, TURBINE CONTROL BOL
K771252 · EIA
Litton Dental Products
Dental · 4d
Cleared Jul 15, 1977
ACCU. CROWN COLD CURE
K771254 · EBG
Briar Cliff, Inc.
Dental · 3d
Cleared Jul 15, 1977
ACRY TEMP
K771257 · EBG
Interstate Dental Co., Inc.
Dental · 4d
Cleared Jul 14, 1977
THERATHERM
K770686 · IRT
Electro Therapeutic Devices, Inc.
Physical Medicine · 93d
Cleared Jul 14, 1977
MONITOR, BED, TECHNOLICS
K770695 · KMI
Technolics, Inc.
General Hospital · 90d
Cleared Jul 14, 1977
TRIGLYCERIDE ENZYMATIC METHOD
K770841 · CDT
Union Carbide Corp.
Chemistry · 66d
Cleared Jul 14, 1977
FLUCOSE U.V. TEST KIT
K770844 · CFR
Mallinckrodt Critical Care
Chemistry · 66d
Cleared Jul 14, 1977
VOLUMET INFUSION PUMP, MODIFI. OF
K770849 · FRN
Sigmamotor, Inc.
General Hospital · 66d
Cleared Jul 14, 1977
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016
K770851 · FMF
Concord Laboratories, Inc.
General Hospital · 66d
Cleared Jul 14, 1977
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015
K770852 · FMF
Concord Laboratories, Inc.
General Hospital · 66d
Cleared Jul 14, 1977
ULTRAZYME PLUS ALP
K770870 · CJE
Harleco
Chemistry · 62d
Cleared Jul 14, 1977
ULTRAZYME PLUS HBD
K770871 · JMK
Harleco
Chemistry · 62d
Cleared Jul 14, 1977
ULTRAZYME PLUS GPT
K770882 · CKA
Harleco
Chemistry · 59d
Cleared Jul 14, 1977
ULTRAZYME PLUS GOT
K770883
Harleco
Chemistry · 59d
Cleared Jul 14, 1977
AUTO-ENZYMATIC GLUCOSE FOR ANALYZER
K770886 · CFR
Harleco
Chemistry · 59d
Cleared Jul 14, 1977
AUTO TOTAL PROTEIN FOR ANALYZER
K770887 · CEK
Harleco
Chemistry · 59d
Cleared Jul 14, 1977
COLORIMETRIC DETERM. SOCITRATE DEHYDRO.
K770902 · JKH
Sigma Chemical Co.
Chemistry · 59d
Cleared Jul 14, 1977
ENZYMATIC CHOLESTEROL REAGENT SET
K770909 · CHH
American Monitor Corp.
Chemistry · 56d
Cleared Jul 14, 1977
GLUTAMATE OXALACETIC TRANSAMINASE
K770917
The Dow Chemical Co.
Chemistry · 56d
Cleared Jul 14, 1977
MONITOR, AERATION, TEC-TEST
K770953 · FRC
Castle Co.
General Hospital · 50d
Cleared Jul 14, 1977
TRANS 2000
K771018 · INK
Hamilton Industries, Inc.
Physical Medicine · 38d