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
168793–168816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1979
MW 8000-I
K792303 · EBF
Midwest
Dental · 11d
Cleared Nov 27, 1979
MW-8000
K792304 · EFB
Midwest
Dental · 11d
Cleared Nov 27, 1979
A.D.E. ASPEN DISPERSIVE ELECTRODE
K792315 · GEI
Zimmer, Inc.
General & Plastic Surgery · 11d
Cleared Nov 21, 1979
ROCHE SENSOR ADAPTOR
K791559 · KLK
Roche Medical Electronics, Inc.
Anesthesiology · 96d
Cleared Nov 21, 1979
SARNS MEDIASTINAL AND PERICARDIAL TUBE
K792070 · DWF
3M Health Care, Sarns
Cardiovascular · 37d
Cleared Nov 21, 1979
MODEL CF-300 THREE CHANNEL FLOW METER
K792190 · DRQ
Wilton Webster Laboratories
Cardiovascular · 21d
Cleared Nov 21, 1979
MEDTRONIC BURR HOLE PLUG & CAP
K792206
Medtronic Vascular
Neurology · 23d
Cleared Nov 21, 1979
ELECTROCARDIOGRAPH, MODEL ECG-5151
K792229 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 16d
Cleared Nov 21, 1979
MEDTRONIC MODEL 9408 TELETRACE TRANSMIT
K792246 · DXH
Medtronic Vascular
Cardiovascular · 14d
Cleared Nov 21, 1979
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON
K792283 · DRR
Arzbaecher & Co.
Cardiovascular · 8d
Cleared Nov 21, 1979
MEDTRONIC MODEL 7728 NEUROMOD
K792311 · GZJ
Medtronic Vascular
Neurology · 5d
Cleared Nov 21, 1979
HEART RATE MONITOR MD-1
K792312 · DRT
Medical Devices, Inc.
Cardiovascular · 5d
Cleared Nov 20, 1979
VISALENS CONCENTRATED CLEANER CONT LENS
K791524 · HPX
Pfizer, Inc.
Ophthalmic · 102d
Cleared Nov 20, 1979
HYDROGEL-PREP
K791726 · NAB
Spenco Medical Corp.
General & Plastic Surgery · 77d
Cleared Nov 20, 1979
ORALUMINATOR III AUTO-LIGHT
K791771 · EAY
Midwest
Dental · 74d
Cleared Nov 20, 1979
HOWMEDICA A-35 DENTAL ALLOY
K791973 · EJS
Howmedica Corp.
Dental · 49d
Cleared Nov 20, 1979
HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY
K792008 · EJS
Howmedica Corp.
Dental · 46d
Cleared Nov 20, 1979
I.V. STRIP
K792049 · KMK
E-Med Corp.
General Hospital · 39d
Cleared Nov 20, 1979
FOLLICLE STIMULATING HORMONE (FSH) KIT
K792063 · CGJ
Cis Radiopharmaceuticals, Inc.
Immunology · 36d
Cleared Nov 20, 1979
POROUS ELASTIC RUBBER BANDAGE
K792065 · FQM
Norman R. Sanborn Co.
General Hospital · 36d
Cleared Nov 20, 1979
HISTO-CENTER II
K792095 · IDW
Thermolyne Corp.
Pathology · 34d
Cleared Nov 20, 1979
COUITER/CMS ISOTONIC BLOOD BANK SALINE
K792101 · JCE
Coulter Electronics, Inc.
Hematology · 32d
Cleared Nov 20, 1979
VITA-STAT MODEL 900-D
K792193 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 19d
Cleared Nov 20, 1979
VITA-STAT MODEL 900-S
K792194 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 19d