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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
150697–150720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1985
TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA
K844752 · DTB
Mansfield Scientific, Inc.
Cardiovascular · 27d
Cleared Jan 02, 1985
KANGAROO ACCESS II ENTERAL FEEDING CONTAINER
K844789 · KNT
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 23d
Cleared Jan 02, 1985
ELECATH GALLAGHER MAPPING CATHETER
K844805 · DRF
Electro-Catheter Corp.
Cardiovascular · 22d
Cleared Jan 01, 1985
LUNG AEROSOL UNIT
K800023 · CAF
Cadema Medical Products, Inc.
General Hospital · 1821d
Cleared Jan 01, 1985
UNKNOWN
K828543
General Electric Co.
Radiology · 775d
Cleared Dec 29, 1984
FILTER PURGE LINE EC-FPL SERIES
K833644 · DTL
Gish Biomedical, Inc.
Cardiovascular · 439d
Cleared Dec 28, 1984
PHOTIC STIMULATOR TM-3030-70
K842964 · GWE
Tracor Northern, Inc.
Neurology · 154d
Cleared Dec 28, 1984
SERVO VENTILATOR 900D SIEMENS-ELEMA AB
K844912 · CBK
Siemens Elema AB
Anesthesiology · 10d
Cleared Dec 27, 1984
CORDIS ENCOR ATRIAL LEAD
K811259 · DTB
Cordis Corp.
Cardiovascular · 1331d
Cleared Dec 27, 1984
EBNA ACIF KIT
K840417 · LLM
Litton Bionetics
Microbiology · 331d
Cleared Dec 27, 1984
ANTI-LEU-4 FITC LYSIN C BUFFER
K842218 · LIZ
Bd Becton Dickinson Vacutainer...
Hematology · 206d
Cleared Dec 27, 1984
VENOUS RESERVOIR-BMR-1500-HARD SHELL
K842373 · DTP
American Bentley
Cardiovascular · 195d
Cleared Dec 27, 1984
RT-50
K843320 · IYO
General Electric Co.
Radiology · 125d
Cleared Dec 27, 1984
ECG PATIENT MONITOR
K843376 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 121d
Cleared Dec 27, 1984
OSTEOGEN
K843398 · LYC
Impladent
Dental · 120d
Cleared Dec 27, 1984
MEDTRONIC 6957
K843706 · DTB
Medtronic Vascular
Cardiovascular · 97d
Cleared Dec 27, 1984
MEADOX SURGIMED A/S CATHETER SHEATH SYS
K843798 · DYB
Meadox Surgimed, Inc.
Cardiovascular · 91d
Cleared Dec 27, 1984
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR
K843802 · DTW
Shiley, Inc.
Cardiovascular · 91d
Cleared Dec 27, 1984
ERGO-OXYSCREEN
K843841 · BZG
Erich Jaeger, Inc.
Anesthesiology · 87d
Cleared Dec 27, 1984
OXYSCREEN
K843860 · BZC
Erich Jaeger, Inc.
Anesthesiology · 87d
Cleared Dec 27, 1984
MYOCARDIAL INSULATOR
K843983 · DTR
Norton Texas Medical Products
Cardiovascular · 77d
Cleared Dec 27, 1984
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
K844003 · LDF
Electro-Catheter Corp.
Cardiovascular · 76d
Cleared Dec 27, 1984
MENSTRUAL PADS
K844035 · HHD
American Disposable Products Corp.
Obstetrics & Gynecology · 72d
Cleared Dec 27, 1984
CANMED 102
K844099 · DRX
Medtronic Vascular
Cardiovascular · 65d