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
143233–143256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1986
PC-PLAN
K862065 · IYE
Dosimetrix, Inc.
Radiology · 88d
Cleared Aug 26, 1986
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
K862638 · LJC
Isolab, Inc.
Microbiology · 47d
Cleared Aug 26, 1986
PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR
K862856 · EJS
Austenal Dental, Inc.
Dental · 28d
Cleared Aug 26, 1986
OTICON I31 CITE HEARING AID
K862980 · ESD
Oticon Corp.
Ear, Nose, Throat · 19d
Cleared Aug 26, 1986
PULMANEX TM (MODIFICATION)
K863026 · BTM
Life Design Systems, Inc.
Anesthesiology · 15d
Cleared Aug 26, 1986
CB BUR
K863097 · EJL
Beavers Dental, Div. Sybron Canada, Ltd.
Dental · 12d
Cleared Aug 26, 1986
PIK POCKET (IRRIGATING TIP)
K863131 · EFS
Teledyne, Inc.
Dental · 11d
Cleared Aug 26, 1986
KULZER GLASS IONOMER LINER
K863141 · EMA
Shofu Dental Corp.
Dental · 11d
Cleared Aug 26, 1986
BUN (RATE) REAGENT
K863196 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 7d
Cleared Aug 25, 1986
ACCULEVEL PHENOBARBITAL TEST
K854607 · DLZ
Syva Co.
Toxicology · 280d
Cleared Aug 25, 1986
ACCULEVEL PHENYTOIN TEST
K855026 · DIP
Syva / A Syntex Co.
Toxicology · 252d
Cleared Aug 25, 1986
PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER
K860289 · GWL
Professional Health Technologies, Inc.
Neurology · 209d
Cleared Aug 25, 1986
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915
K860488 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 196d
Cleared Aug 25, 1986
CIRCADIAN STRESS TEST SYSTEM
K860973 · DPS
Circadian, Inc.
Cardiovascular · 164d
Cleared Aug 25, 1986
WYLER SPHENOIDAL ELECTRODE
K861031 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 160d
Cleared Aug 25, 1986
DAKO ITA SYSTEM
K861059 · DEW
Dako Corp.
Immunology · 159d
Cleared Aug 25, 1986
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
K861504 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 124d
Cleared Aug 25, 1986
860 COLOR DOPPLER OR COLORVIEW 860
K861538 · IYO
Ge Medical Systems Information...
Radiology · 123d
Cleared Aug 25, 1986
LIFESCAN EVOKED POTENTIAL SYSTEM
K861900 · GWF
Neurometrics
Neurology · 101d
Cleared Aug 25, 1986
ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
K861981 · DRW
Vital Signs, Inc.
Cardiovascular · 95d
Cleared Aug 25, 1986
[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
K862056 · DQY
Arrow Intl., Inc.
Cardiovascular · 87d
Cleared Aug 25, 1986
AMNIOINFUSION CATHETER
K862182 · KXO
Michael Reese Hospital and Medical...
Obstetrics & Gynecology · 77d
Cleared Aug 25, 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
K862244 · DQO
Cordis Corp.
Cardiovascular · 74d
Cleared Aug 25, 1986
CORNEAL MODELING SYSTEM
K862379 · HJO
Computed Anatomy, Inc.
Ophthalmic · 62d