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
168985–169008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1979
NITRATE BROTH
K791945 · JSF
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
OF BASAL MEDIUM
K791946 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
PDC 304 DOUBLE SWAB CULTURE COLLECTION
K791953 · JTW
Precision Dynamics Corp.
Microbiology · 29d
Cleared Oct 30, 1979
REPL. PISTON FOR TROUTMAN CORNEAL PUNCH
K791988 · HNJ
Edward Weck, Inc.
Ophthalmic · 35d
Cleared Oct 30, 1979
ANTI NUCLEAR ANTIBODY TEST
K791995 · DHN
Meda Stat Diagnostics, Inc.
Immunology · 27d
Cleared Oct 30, 1979
(125I) TESTOSTERONE KIT
K791999 · CDZ
Radioassay Systems Laboratories, Inc.
Chemistry · 25d
Cleared Oct 30, 1979
LUTEINIZING HORMONE (LH) RIA
K792000 · CEP
Cis Radiopharmaceuticals, Inc.
Chemistry · 25d
Cleared Oct 30, 1979
VOLU-SOL STAT STAIN
K792017 · IAF
Volu Sol Medical Industries
Hematology · 21d
Cleared Oct 30, 1979
ESKACHEM, CK-MB REAGENT
K792023 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 21d
Cleared Oct 30, 1979
LIPOTROL
K792024 · JJY
Helena Laboratories
Chemistry · 21d
Cleared Oct 30, 1979
LYOPHILIZED HDL CHOLESTEROL CONTROLS
K792025 · JJY
Helena Laboratories
Chemistry · 21d
Cleared Oct 30, 1979
PREGTELL I
K792027 · JHJ
Central Biological Co.
Immunology · 21d
Cleared Oct 30, 1979
TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT
K792030 · BZO
Airlife, Inc.
Anesthesiology · 21d
Cleared Oct 30, 1979
CORTISOL RADIOIMMUNOASSAY SYSTEM
K792036 · CGR
Radioimmunoassay, Inc.
Chemistry · 19d
Cleared Oct 30, 1979
WILLIAM HARVEY H-1500 BLOOD OXYGENATOR
K792039 · DTZ
C.R. Bard, Inc.
Cardiovascular · 18d
Cleared Oct 30, 1979
DHEA-SULFATE TEST SET
K792041 · JKC
Wien Laboratories, Inc.
Chemistry · 18d
Cleared Oct 30, 1979
PAP-CHECK RIA KIT
K792043 · JFH
Serono Laboratories, Inc.
Chemistry · 18d
Cleared Oct 30, 1979
BIOVATION NEPHELOMETER
K792045 · JQX
Biovation, Inc.
Chemistry · 18d
Cleared Oct 30, 1979
URIC ACID STANDARD
K792046 · JIS
Gilford Diagnostics
Chemistry · 18d
Cleared Oct 30, 1979
CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,
K792047 · BZO
Airlife, Inc.
Anesthesiology · 18d
Cleared Oct 30, 1979
DELTA ROLLING SELF-LICKING WALKER
K792064 · ITJ
Staricat, Inc.
Physical Medicine · 15d
Cleared Oct 30, 1979
TRACHEOSTOMY CARE KIT
K792069 · BTO
National Patent Development Corp.
Anesthesiology · 15d
Cleared Oct 30, 1979
C-ERA-100 COMPUTERIZED ELECTRIC RESPON
K792085 · GWJ
Micro-Shev , Ltd.
Neurology · 13d
Cleared Oct 26, 1979
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
K791373 · CFE
Hoffmann-La Roche, Inc.
Chemistry · 94d