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
163561–163584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1981
PH/BLOOD GAS CONTROL (ABC)
K811143 · JJS
Instrumentation Laboratory CO
Chemistry · 16d
Cleared May 13, 1981
HOYT ECONO-TRAY
K811154 · KMT
Hoyt Laboratories
Dental · 15d
Cleared May 13, 1981
HEARING AID, UNITRON MODEL C5-H
K811174 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 15d
Cleared May 13, 1981
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE
K811181 · EOQ
American Optical Corp.
Ear, Nose, Throat · 15d
Cleared May 13, 1981
DAHLBERG MODEL AM
K811226 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 9d
Cleared May 13, 1981
DISPOSABLE HOLDER FOR HANCOCK MITRAL
K811235 · DTJ
Vascor, Inc.
Cardiovascular · 9d
Cleared May 13, 1981
DISPOSABLE HOLDER FOR HANCOCK AORTIC
K811236 · DTJ
Vascor, Inc.
Cardiovascular · 9d
Cleared May 11, 1981
INSTRUMENT CLEANER LIQUID CONCENTRATE
K803154
Abco Dealers, Inc.
General & Plastic Surgery · 150d
Cleared May 11, 1981
ELECTRODYN CII-INTERFERENTIAL MUSCLE
K810513 · IPF
Nemectron Medical, Inc.
Physical Medicine · 76d
Cleared May 08, 1981
LIXIVITRON
K802828 · LIF
United Medical
Gastroenterology & Urology · 179d
Cleared May 08, 1981
HOME HEALTH CHEKUP KIT
K810488 · KHE
Healthkit
Hematology · 74d
Cleared May 08, 1981
ELECTRODE BLOOD PRESSURE MONITOR
K810635 · DSK
Sears, Roebuck & Co.
Cardiovascular · 59d
Cleared May 08, 1981
LANCER GLYCOSYLATED HEMOGLOBIN
K810638 · LCP
Sherwood Medical Co.
Hematology · 59d
Cleared May 08, 1981
CAPD CATHETER ADAPTER
K810683 · FKX
American Mcgaw
Gastroenterology & Urology · 56d
Cleared May 08, 1981
HAEMONETICS 600 ML. COMPONENT BAG
K810711 · KSR
Haemonetics Corp.
Hematology · 52d
Cleared May 08, 1981
LANCER GLYCOSYLATED HEMOGLOBIN ASSAY
K810714 · LCP
Sherwood Medical Co.
Hematology · 52d
Cleared May 08, 1981
DISPOSABLE, STERILE TRANSDUCER DOMES
K810735 · DRS
Bio-Med Corp.
Cardiovascular · 51d
Cleared May 08, 1981
HANKS' BALANCED SALT SOLUTION W/O CA-MG
K810766 · KIP
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared May 08, 1981
RPMI 1640 MEDIUM
K810767 · KIT
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared May 08, 1981
GOAT SERUM-STERILE
K810775 · KIS
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared May 08, 1981
HANKS' BALANCED SALTS SOLUTION (MODIF.)
K810777 · KIP
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared May 08, 1981
EPILATRON
K810843 · KCW
Electrola
General & Plastic Surgery · 42d
Cleared May 08, 1981
DOUBLE VELOUR GRAFTS
K810845 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 42d
Cleared May 08, 1981
5CM SMALL PARTS SCANNER
K810914 · IYO
Smithkline Diagnostics, Inc.
Radiology · 32d