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
166009–166032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1980
SI-14
K801908 · KDC
Kmi Medical, Inc.
General & Plastic Surgery · 93d
Cleared Nov 12, 1980
TUTTIFRUTTI (NON-PRES. SUNGLASSES)
K801922 · HQY
Safety Plastics of New York
Ophthalmic · 92d
Cleared Nov 12, 1980
ANALYTIC TECH. METAL POINT HEATER #3001
K801974 · ELA
Analytic Technology
Dental · 85d
Cleared Nov 12, 1980
DATASON DB SYSTEM
K801986 · IYO
General Electric Co.
Radiology · 85d
Cleared Nov 12, 1980
OBJECTIVE REFRACTOR
K802029 · HKO
Zeiss Humphrey System
Ophthalmic · 83d
Cleared Nov 12, 1980
TM-5 INTRACRANIAL PRESSURE MONITOR
K802149 · GWM
Nicolet Biomedical Instruments
Neurology · 65d
Cleared Nov 12, 1980
CBC PAP TEST KIT
K802153 · JFH
Calbiochem-Behring Corp.
Chemistry · 65d
Cleared Nov 12, 1980
MODEL AS* 7B AUTOSYRINGE INFUSION PUMP
K802166 · FLN
Baxter Healthcare Corp
General Hospital · 65d
Cleared Nov 12, 1980
CARDIOSCOPE J200
K802179 · DRS
Telectronics, Inc.
Cardiovascular · 64d
Cleared Nov 12, 1980
ATGM MODEL AT-80
K802191 · DXN
Herald of America, Inc.
Cardiovascular · 63d
Cleared Nov 12, 1980
KOTEX SECURITY TUBE TAMPONS
K802193 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 63d
Cleared Nov 12, 1980
AB-TROL COAGULATION CONTROL
K802232 · GGW
Helena Laboratories
Hematology · 58d
Cleared Nov 12, 1980
VAXIOM FAMILY OF RF LESION PROBES & ELEC
K802243 · GXI
Progress Mankind Technology
Neurology · 57d
Cleared Nov 12, 1980
CBC PLT-4
K802265 · JPK
R&D Systems, Inc.
Hematology · 57d
Cleared Nov 12, 1980
PLT-4 SIZE-CHECK
K802267 · JPK
R&D Systems, Inc.
Hematology · 57d
Cleared Nov 12, 1980
HI-TEMP LOOPTIP SURGICAL CAUTERY
K802330 · GEI
Medical Products Development, Inc.
General & Plastic Surgery · 50d
Cleared Nov 12, 1980
INSTANT BRIDGE
K802333 · KLE
Scientific Pharmaceuticals, Inc.
Dental · 50d
Cleared Nov 12, 1980
12SSL ECG ANALYSIS PROG.(SCALER LEAD)
K802369 · LOS
Marquette Electronics, Inc.
Cardiovascular · 44d
Cleared Nov 12, 1980
SURGICAL FACE MASK
K802373 · FXX
Louis M. Gerson Co., Inc.
General Hospital · 44d
Cleared Nov 12, 1980
CUSTOM DRESSING TRAY/CARDINAL CUSHING
K802383 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 41d
Cleared Nov 12, 1980
CENTRAL VENOUS CATHETER DRESSING TRAY
K802384 · FPX
American Medical Disposable, Inc.
General & Plastic Surgery · 41d
Cleared Nov 12, 1980
CUSTOM DRESSING TRAY-WET TO DRY/MASS.
K802385 · FPX
American Medical Disposable, Inc.
General & Plastic Surgery · 41d
Cleared Nov 12, 1980
SUTURE WOUND TRAY MILFORD WHITTINSVILLE
K802386 · FMC
American Medical Disposable, Inc.
General Hospital · 41d
Cleared Nov 12, 1980
MINOR DRESSING TRAY-MILFORD HOSP.
K802387 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 41d