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
170041–170064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1979
BLOOD GAS SYSTEM MODEL 168
K781968 · CHL
Corning Medical & Scientific
Chemistry · 40d
Cleared Jan 03, 1979
BLOOD, HEMATOLOGY REFERENCE CONTROL
K781969 · JPK
Coulter Electronics, Inc.
Hematology · 40d
Cleared Jan 03, 1979
CHOLESTEROL REAGENT SUBSTRATE SET
K781970 · JHO
Corning Medical & Scientific
Chemistry · 40d
Cleared Jan 03, 1979
ACID REAGENT, URIC SINGLE VIAL
K781996 · CDO
Calbiochem-Behring Corp.
Chemistry · 35d
Cleared Jan 03, 1979
ROTARY SCALER
K782007 · ELB
Star Dental Mfg. Co.
Dental · 33d
Cleared Jan 03, 1979
FIAX TEST KIT
K782041 · DHN
Idt, A Division of Whittaker M.A....
Immunology · 27d
Cleared Jan 03, 1979
PRINTER, TEK PRO TEK TALLY II
K782050 · GKZ
Tekpro
Hematology · 26d
Cleared Jan 03, 1979
EXETRELUT
K782066 · KEA
Mcb Manufacturing Chemists, Inc.
Toxicology · 21d
Cleared Jan 03, 1979
DILATOR, MIZUTANI LAMINARIA TENT
K782067 · HDY
British Marketing Ent., Ltd.
Obstetrics & Gynecology · 21d
Cleared Jan 03, 1979
VAGATEX
K782083 · HIR
Vagatex
Gastroenterology & Urology · 20d
Cleared Jan 03, 1979
HYCEL COUNTER 333
K782100 · GKL
Hycel, Inc.
Hematology · 16d
Cleared Jan 03, 1979
HYCEL COUNTER 222
K782101 · GKL
Hycel, Inc.
Hematology · 16d
Cleared Jan 03, 1979
HYCEL COUNTER 211
K782102 · GKL
Hycel, Inc.
Hematology · 16d
Cleared Jan 03, 1979
PASTE, PRO CARE PROPHYLAXIS
K782104 · FZE
Young Dental Manufacturing Co. 1, LLC
General & Plastic Surgery · 15d
Cleared Jan 02, 1979
DIFFUSION OPTION, OMNI-LAB
K781871 · CCJ
Ohio Medical Products
Anesthesiology · 60d
Cleared Jan 02, 1979
GENERATOR, BIOTEC 876 PULSE
K790031
Biomagnetic Technologies, Inc.
Cardiovascular
Cleared Dec 29, 1978
BETA-TEC
K781794 · JHI
Wampole Laboratories
Immunology · 65d
Cleared Dec 29, 1978
LIGHT, INSIDE
K781878 · EAY
Midwest
Dental · 53d
Cleared Dec 29, 1978
STOCKINETTE
K781944 · KKX
Kimberly-Clark Corp.
General Hospital · 38d
Cleared Dec 29, 1978
HT-110 MICROMINI
K782076 · DXH
Health Tech
Cardiovascular · 16d
Cleared Dec 29, 1978
MEDTRONIC MODEL 546
K782108 · DTE
Medtronic Vascular
Cardiovascular · 10d
Cleared Dec 28, 1978
GOLD, 24 KARAT CASTING
K781788 · EJT
Williams Gold Refining Co., Inc.
Dental · 70d
Cleared Dec 28, 1978
MODULAT DENTAL SYSTEMS
K781882 · EIA
Vacudent Sales Corp.
Dental · 65d
Cleared Dec 28, 1978
IMPLANT DRIVERS AND TIPS
K781974 · DZJ
Miter, Inc.
Dental · 31d