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
165937–165960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1980
PDS THERMAL DILUTION CARDIAC MODULE(OUT)
K802316 · DXG
General Electric Co.
Cardiovascular · 64d
Cleared Nov 26, 1980
SPECIAL PROCEDURE AQAROSE FILM
K802395 · JJN
Electrophoresis Corp.
Chemistry · 55d
Cleared Nov 26, 1980
GENERAL PROCEDURE AGAROSE FILM
K802396 · JJN
Electrophoresis Corp. of America
Chemistry · 55d
Cleared Nov 26, 1980
BIOMETRIC ERG SYSTEM
K802472 · DSI
Biometric Analysis Group, Inc.
Cardiovascular · 48d
Cleared Nov 26, 1980
A2 IMAGE PROCESSING SYSTEM
K802475 · IYX
Medtronic Vascular
Radiology · 48d
Cleared Nov 26, 1980
CHEMISTRY ANALYZER IMPACT 400
K802609 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 36d
Cleared Nov 26, 1980
CAFFEINE REAGENT DIAZO COLORIMETRY
K802630 · CIG
American Monitor Corp.
Chemistry · 34d
Cleared Nov 26, 1980
TECA MODEL-10 ELECTROMYOGRAPH
K802637 · IKN
Teca, Inc.
Neurology · 35d
Cleared Nov 26, 1980
UCA CREAM PRODUCT REFORMULATION
K802648 · GYB
Vanaray Laboratories, Inc.
Neurology · 37d
Cleared Nov 26, 1980
MODEL T-6 EEG TELEPHONE TRANSMITTER
K802656 · GYE
Telediagnostic Systems, Inc.
Neurology · 33d
Cleared Nov 26, 1980
APTEK ULTRASOUND PROCEDURE TRAY
K802666 · HIO
Aptek , Ltd.
Obstetrics & Gynecology · 29d
Cleared Nov 26, 1980
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · DXK
American Edwards Laboratories
Cardiovascular · 30d
Cleared Nov 26, 1980
HP MODEL 8880A FILTER
K802686 · DRR
Hewlett-Packard Co.
Cardiovascular · 29d
Cleared Nov 26, 1980
ENTERMED ENTUNIT
K802712 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 26d
Cleared Nov 26, 1980
COBE/STOCKERT BATTERY MODULE
K802714 · DWB
Cobe Laboratories, Inc.
Cardiovascular · 26d
Cleared Nov 26, 1980
MODEL 4700A ELECTROCARDIOGRAPH
K802718 · DPS
Hewlett-Packard Co.
Cardiovascular · 26d
Cleared Nov 26, 1980
NORMOCAP CR-102, RECORDER UNIT
K802762 · CCL
Instrumentarium-Datex
Anesthesiology · 22d
Cleared Nov 26, 1980
RESPIRGARD
K802763 · CAH
Marquest Medical Products, Inc.
General Hospital · 22d
Cleared Nov 26, 1980
RIONET HEARING AID
K802812 · KHL
Kindel & Anderson
Ear, Nose, Throat · 19d
Cleared Nov 25, 1980
ARTERIOVENOUS BLOOD TUBING SETS
K802874 · FJK
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 8d
Cleared Nov 24, 1980
IN VITRO DIAGNOSTIC STANDARDS
K802278 · DIF
Supelco, Inc.
Toxicology · 73d
Cleared Nov 24, 1980
ROBERTSON OBTURATION MONITOR INSUFFLA
K802374 · FAP
Endotek Corp.
Gastroenterology & Urology · 56d
Cleared Nov 24, 1980
SERUM T4 BY ENZYME IMMUNOASSAY
K802573 · CDX
Worthington Diagnostic Systems
Chemistry · 38d
Cleared Nov 24, 1980
MEDIUM SIZE OXYGEN HOOD #1547
K802653 · BYL
Ann Arbor Plastics, Inc.
Anesthesiology · 31d