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
165913–165936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1980
DR. MICHAEL'S FOOT HELPER
K802837 · LDQ
Dr. Michael'S Foot-Care Products
General & Plastic Surgery · 28d
Cleared Dec 09, 1980
BIOLOGICAL INDICATOR - KEMMED & BIOSURE
K802228 · FRC
Kem Medical Products Corp.
General Hospital · 90d
Cleared Dec 09, 1980
CHEMICAL INDICATOR - KEM MED & BIO SURE
K802229 · JOJ
Kem Medical Products Corp.
General Hospital · 90d
Cleared Dec 05, 1980
BIOLUMIN. SCREENING FOR BACT. BY ATP A.
K803077
Technology, Inc.
Chemistry
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80
K802548 · IZO
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, MPX 100
K802549 · IZO
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, MPX 125
K802550 · IZO
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, MPX100/125
K802551 · IZO
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
PHADEBAS RAST TEST
K802556 · DHB
Pharmacia, Inc.
Immunology · 47d
Cleared Dec 01, 1980
INTERMEDICS' LIFELINE TLE ENDOCARDIAL
K801172 · DTB
Intermedics, Inc.
Cardiovascular · 199d
Cleared Dec 01, 1980
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)
K801284 · DTB
Medtronic Vascular
Cardiovascular · 186d
Cleared Dec 01, 1980
SIEMENS-ELEMA PULSE GENERATOR 668
K801324 · DXY
Siemens Elema AB
Cardiovascular · 181d
Cleared Dec 01, 1980
TRAVENOL ULTRASONIC NEBULIZER CUPS
K802054 · CAP
Travenol Laboratories, S.A.
Anesthesiology · 98d
Cleared Dec 01, 1980
GRISTINA GLENOID PROSTHESIS
K802124 · KWT
Howmedica Corp.
Orthopedic · 88d
Cleared Dec 01, 1980
SOLAR TONE
K802304 · LEJ
Bloomex International, Inc.
Radiology · 69d
Cleared Dec 01, 1980
T/K (ATA/AMA) UNIVERSAL BIOPAK
K802308 · DBM
Bioware Products
Immunology · 69d
Cleared Dec 01, 1980
MS-2 IDENTIFICATION SYSTEM
K802309 · JXB
Abbott Laboratories
Microbiology · 69d
Cleared Dec 01, 1980
VON WILLEBRAND FACTOR ASSAY
K802356 · GGP
Bio/Data Corp.
Hematology · 66d
Cleared Dec 01, 1980
GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.
K802432 · LCP
Clin Tech Diagnostics Corp.
Hematology · 56d
Cleared Dec 01, 1980
SINVISION 2001 ULTRASOUND SCANNER
K802484
National Ultrasound Corp.
Obstetrics & Gynecology · 46d
Cleared Dec 01, 1980
TENSMATE EMPIMODEL 9980
K802507 · GZJ
Empi
Neurology · 47d
Cleared Nov 28, 1980
AUXILIARY TRAY
K802088 · FSM
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 87d
Cleared Nov 26, 1980
GENERAL ULTRASOUND EXAM. TABLE
K802254 · IYN
Engineering Dynamics Corp.
Radiology · 71d
Cleared Nov 26, 1980
PERICARDIOCENTESIS KIT
K802289 · DOR
Stanco Medical, Inc.
Toxicology · 68d