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
171313–171336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1978
DISPOSABLE INCENTIVE SPIROMETER
K781394 · CCQ
Inhal-O-Tech Medical Plastic
Anesthesiology · 63d
Cleared Oct 16, 1978
PATIENT CIRCUIT MANIFOLD
K781485 · CAF
Bourns Medical Systems, Inc.
Anesthesiology · 49d
Cleared Oct 16, 1978
NEBULIZER/HUMIDIFIER MODEL EH 147B
K781591 · KFZ
Mistogen Equipment Co.
Anesthesiology · 28d
Cleared Oct 15, 1978
MONITOR, HEART RATE
K781166 · DRT
Cybernetic Medical, Inc.
Cardiovascular · 95d
Cleared Oct 15, 1978
METER, FLOW, PEAK
K781224 · BZH
Projects IN Health
Anesthesiology · 90d
Cleared Oct 13, 1978
NURITE II, SINGLE
K781683 · GZJ
Bio-Medical Systems Corp.
Neurology · 11d
Cleared Oct 12, 1978
MONITOR, PO2, INTRAVASCULAR
K781271 · CCE
Roche Medical Electronics, Inc.
Anesthesiology · 80d
Cleared Oct 11, 1978
OSCILLATING KNIFE AND ACCESSORIES
K781412 · HMY
Codman & Shurtleff, Inc.
Ophthalmic · 57d
Cleared Oct 11, 1978
EARLY PREGNANCY DETECTION KIT
K781487 · JHI
Radioassay Systems Laboratories, Inc.
Chemistry · 44d
Cleared Oct 11, 1978
RAD-291
K781554 · JQX
Organon, Inc.
Chemistry · 30d
Cleared Oct 11, 1978
ELECTRICAL NERVE STIMULATOR MODEL 6035
K781565 · GZJ
Stimulation Technology, Inc.
Neurology · 28d
Cleared Oct 11, 1978
PERFIT DENTAL RESTORATIVE COMPOSITE
K781580 · EBF
Locite Corp.
Dental · 26d
Cleared Oct 11, 1978
NASOSTAT
K781615 · EMX
Nasostat, Inc.
Ear, Nose, Throat · 20d
Cleared Oct 11, 1978
C.P.R. COUNTING PACER
K781636
Qual-Tec, Inc.
Cardiovascular · 19d
Cleared Oct 10, 1978
TRANSCUTANEOUS OXYGEN PERFUSION MONITOR
K780458 · KLK
Narco Air-Shields
Anesthesiology · 201d
Cleared Oct 10, 1978
FUNGUS FIGHTER INSOLES
K780719 · KYS
Combe, Inc.
General Hospital · 162d
Cleared Oct 10, 1978
EPILATOR, EASE-MULTI-MODE
K781147 · KCW
Greenleaf-Carter Enterprises, Inc.
General & Plastic Surgery · 92d
Cleared Oct 10, 1978
HEAT EXCHANGER, FHX-14
K781210 · DTR
Delta Medical Industries
Cardiovascular · 85d
Cleared Oct 10, 1978
SURGITEK DISPOSABLE FLO-RESTER
K781336 · DWS
Medical Engineering Corp.
Cardiovascular · 68d
Cleared Oct 10, 1978
PAPILLOTOME CUTTING SNARE
K781353 · KNS
Cameron-Miller, Inc.
Gastroenterology & Urology · 64d
Cleared Oct 10, 1978
EMIT N-ACETYLPROCAINAMIDE ASSAY
K781378 · LAN
Syva Co.
Toxicology · 61d
Cleared Oct 10, 1978
EMIT METHATREXATE ASSAY
K781381 · LAO
Dade Behring, Inc.
Toxicology · 60d
Cleared Oct 10, 1978
BCG ALBUMIN REAGET
K781441 · CIX
Analytical & Research Chemicals, Inc.
Chemistry · 50d
Cleared Oct 10, 1978
CHLORIDE REAGENT
K781460 · CHJ
Analytical & Research Chemicals, Inc.
Chemistry · 50d