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

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176,076 results
164401–164424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1981
ESOPHAGEAL PILL ELECTRODE
K810895 · DRX
Con Med Equipment, Inc.
Cardiovascular · 40d
Cleared May 13, 1981
GAMMA CAMERA
K810974 · IYX
Siemens Gammasonics, Inc.
Radiology · 33d
Cleared May 13, 1981
ENDODONTIC POST SYSTEMS
K810977 · ECG
Preat Corp.
Dental · 33d
Cleared May 13, 1981
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K811033 · BTO
Shiley, Inc.
Anesthesiology · 28d
Cleared May 13, 1981
BALANCE ARTICULATOR
K811075 · EJP
Almore Intl., Inc.
Dental · 23d
Cleared May 13, 1981
HCG RADIOIMMUNOASSAY
K811116 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 19d
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