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
161353–161376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1982
FITC ANTI-RABIES MONOCLONAL GLOBULIN
K820499 · GOI
Centocor, Inc.
Microbiology · 52d
Cleared Apr 16, 1982
NEWPORT VENTILATOR MODEL E100
K820746 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 28d
Cleared Apr 16, 1982
LH RADIOIMMUNOASSAY TEST SYSTEM
K820760 · CEP
Monobind
Chemistry · 25d
Cleared Apr 16, 1982
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
K820769 · FKQ
Gambro, Inc.
Gastroenterology & Urology · 25d
Cleared Apr 16, 1982
CULTURE MEDIA, SINGLE BIOCHEM. TEST
K820839 · JSF
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
CULTURE MEDIA, GENERAL NUTRIENT BROTH
K820840 · JSC
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
CULTURE MEDIA, MULTIPLE BIOCHEMICAL
K820841 · JSE
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
CULTURE MEDIA, NON-SELECTIVE/DIFFER
K820842 · JSE
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
CULTURE MEDIA SELECTIVE BROTH
K820843 · JSD
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
CULTURE MEDIA, SELECTIVE & DIFFERENTIAL
K820844 · JSI
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
DULTURE MEDIA, SELECTIVE & NON-DIFFER
K820845 · JSJ
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
ANTIMICROBIAL SUSCEP. TEST, MUELLER
K820846 · JTZ
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
ISOLATION OF PATHOGENIC NEISSERIA
K820847 · JTY
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
BLUE RIDGE SHEEP BLOOD
K820848 · LHW
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
BLUE RIDGE RABBIT BLOOD
K820849 · LHW
Blue Ridge Media Co.
Microbiology · 21d
Cleared Apr 16, 1982
COAXIAL DUAL FLOW CATHETER
K820859 · LBW
Terumo Medical Corp.
Gastroenterology & Urology · 18d
Cleared Apr 16, 1982
MEDIA FOR IN-VITRO DIAGNOSTIC USE
K820863 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 18d
Cleared Apr 16, 1982
CORNING CERTAIN TM
K820873 · JJS
Corning Medical & Scientific
Chemistry · 18d
Cleared Apr 16, 1982
ENZYME-TEST TBC T4 UPTAKE
K820879 · KHQ
Icl Scientific
Chemistry · 17d
Cleared Apr 16, 1982
SERALYZER CK REAGENT STRIPS
K820880 · CGS
Miles Laboratories, Inc.
Chemistry · 17d
Cleared Apr 16, 1982
THYROXINE T4 KIT
K820886 · CDX
Pcl-Ria, Inc.
Chemistry · 17d
Cleared Apr 16, 1982
MODEL 5866-26 LEAD ADAPTER KIT
K820935 · DTD
Medtronic Vascular
Cardiovascular · 14d
Cleared Apr 16, 1982
INCONTINENCE PAD OR ADULT DIAPER
K820961 · EYQ
Dafoe & Dafoe, Inc.
Gastroenterology & Urology · 10d
Cleared Apr 16, 1982
WHEELCHAIR PAL
K820964 · KNO
Pryor Products
Physical Medicine · 10d