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

Filters: Cleared only ×
176,076 results
173857–173880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1977
AV FISTULA NEEDLE SET
K771206 · FIE
Terumo America, Inc.
Gastroenterology & Urology · 10d
Cleared Jul 15, 1977
SUPERFINE DIAMONDS
K771214 · EJL
Den-Mat Corp.
Dental · 10d
Cleared Jul 15, 1977
PHENYTOIN ANALYTICAL TEST PACKS
K771233 · DIP
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 8d
Cleared Jul 15, 1977
RID PLATES & INTENSI. FOR HUMAN IGE ETC
K771238 · DGC
G.D. Searle and Co.
Immunology · 4d
Cleared Jul 15, 1977
ALARM SYS FOR NITROUS OXIDE SYS.
K771246 · ECX
Star Dental Mfg. Co.
Anesthesiology · 4d
Cleared Jul 15, 1977
CORE MATERIAL
K771247 · EBF
Star Dental Mfg. Co.
Dental · 4d
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