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
170929–170952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1978
API ZYM
K781567 · JTO
Analytical Products, Inc.
Microbiology · 97d
Cleared Dec 20, 1978
UROTRON
K781632 · JJQ
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared Dec 20, 1978
RUBINDEX*DIRECT SYSTEM
K781638 · GOK
Ortho Diagnostics, Inc.
Immunology · 90d
Cleared Dec 20, 1978
SURGICAL GOWNS & DRAPES
K781682 · FYA
Kimberly-Clark Corp.
General Hospital · 79d
Cleared Dec 20, 1978
LINER, CAVITY CALCIUM HYDROXIDE
K781688 · EJK
Kerr Corporation (Danbury)
Dental · 77d
Cleared Dec 20, 1978
CHEMSTRIP CONTROL
K781691 · JJW
Boehringer Mannheim Corp.
Chemistry · 77d
Cleared Dec 20, 1978
EXTUBE
K781728 · KEA
Analytichem International, Inc.
Toxicology · 75d
Cleared Dec 20, 1978
RIA KIT, PREG-STAT
K781733 · JHI
Serono Laboratories, Inc.
Immunology · 68d
Cleared Dec 20, 1978
HUMIDIFIERS, MODEL:LS-420 AND LS-460
K781760 · BTT
Bourns Medical Systems, Inc.
Anesthesiology · 65d
Cleared Dec 20, 1978
COMPRESSION HIP SCREW SYSTEM
K781762 · KTW
Howmedica Corp.
Orthopedic · 65d
Cleared Dec 20, 1978
DETECTOR, MODEL 79875A, VARIABLE
K781771 · KIE
Hewlett-Packard Co.
Toxicology · 68d
Cleared Dec 20, 1978
ABRASIVE WHEELS
K781777 · EJQ
Dentsply Intl.
Dental · 68d
Cleared Dec 20, 1978
ISOPLAST
K781787 · EBF
Vivadent (Usa), Inc.
Dental · 62d
Cleared Dec 20, 1978
WASHER SYSTEM, MICROELISA
K781802 · JTC
Metrix Teknika, Inc.
Chemistry · 58d
Cleared Dec 20, 1978
ELECTROSURGICAL UNIT 3001-3009
K781810 · GEI
Neomed Corp.
General & Plastic Surgery · 55d
Cleared Dec 20, 1978
BLOOD GROUP SUBSTANCE A
K781862 · KSX
North American Biologicals, Inc.
Hematology · 44d
Cleared Dec 20, 1978
MYCOPLASMA ARGININI FITC (30-403-41)
K781874 · KPB
Flow Laboratories, Inc.
Pathology · 47d
Cleared Dec 20, 1978
STAIN KIT FOR CELL CULTURES (30-100-00)
K781875 · KPB
Flow Laboratories, Inc.
Pathology · 47d
Cleared Dec 20, 1978
SERUM, CREATININE DETERMINATIONS
K781884 · CGX
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Dec 20, 1978
SERUM, BLOOD UREA NITIOGEN
K781885 · CDW
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Dec 20, 1978
CONTROL, PROTEIN ELECTROPHORESIS
K781893 · JJY
Sigma Chemical Co.
Chemistry · 42d
Cleared Dec 20, 1978
BLOOD GROUP SUBSTANCE B
K781895 · KSX
North American Biologicals, Inc.
Hematology · 44d
Cleared Dec 20, 1978
BLOOD GROUP SUBSTANCE A,B
K781896 · KSX
North American Biologicals, Inc.
Hematology · 44d
Cleared Dec 20, 1978
CLEARING SOLUTION #ECA01976
K781898 · JQK
Electrophoresis Corp. of America
Chemistry · 37d