FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
170473–170496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 10, 1978
RUBBER DAM HOLDER
K781520 · EJE
Young Dental Manufacturing Co. 1, LLC
Dental · 39d
Cleared Oct 10, 1978
NEBULIZER/HUMIDIFIER
K781537 · BTT
Chemetron Medical Products, Inc.
Anesthesiology · 39d
Cleared Oct 10, 1978
HEATED NEBULIZER
K781542 · CAF
Chemetron Medical Products, Inc.
Anesthesiology · 32d
Cleared Oct 10, 1978
PRESSURE MONITORING INJECTION LINES
K781558 · DQO
Cobe Laboratories, Inc.
Cardiovascular · 29d
Cleared Oct 10, 1978
RIA QUANT B-HCG TEST KIT
K781578 · JHI
Mallinckrodt Critical Care
Chemistry · 25d
Cleared Oct 10, 1978
PAPANICOLAOU STAIN EA-36
K781582 · HZJ
Bioscientific
Pathology · 22d