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
173305–173328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1977
I.L. MODEL 643 FLAME PHOTOMETER
K771337 · JJO
Instrumentation Laboratory CO
Chemistry · 91d
Cleared Oct 18, 1977
IFA ANTI-NDNA
K771376 · DHN
Electro-Nucleonics Laboratories, Inc.
Immunology · 85d
Cleared Oct 18, 1977
NEO TSH-RIA KIT
K771378 · JLW
Nuclear Medical Systems, Inc.
Chemistry · 90d
Cleared Oct 18, 1977
TENCKHOFF PERITONEAL TUBING ADAPT.
K771428 · FKY
Quinton, Inc.
Gastroenterology & Urology · 78d
Cleared Oct 18, 1977
STAT/LYTE ANALYZER
K771592 · JFL
Technicon Instruments Corp.
Chemistry · 60d
Cleared Oct 18, 1977
ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE
K771645 · DSA
Tronomed, Inc.
Cardiovascular · 50d
Cleared Oct 18, 1977
ALKALINE PHOSPHATASE TEST
K771695 · CJE
Sclavo, Inc.
Chemistry · 42d
Cleared Oct 18, 1977
DERTRAN-COATED CHARCOAL TABLETS
K771704
Reflex Industries, Inc.
Chemistry · 42d
Cleared Oct 18, 1977
TEK-CHEK-2
K771713 · JJW
Miles Laboratories, Inc.
Chemistry · 36d
Cleared Oct 18, 1977
BARBITAL BUFFER
K771721
Sigma Chemical Co.
Chemistry · 35d
Cleared Oct 18, 1977
GLUCOSE REAGENT FOR GLUC. ANALYZER
K771754 · CGA
Harleco
Chemistry · 32d
Cleared Oct 18, 1977
FOLLICLE-STIMULATING HORMONE
K771756 · CGJ
Nichols Institute Diagnostics
Chemistry · 32d
Cleared Oct 18, 1977
RUBA-NOST TEST KITS
K771796 · GOL
Behring Diagnostics, Inc.
Microbiology · 25d
Cleared Oct 18, 1977
LIPPOPROTEIN ELECTROPHORESIS REAGENT SET
K771812 · DFC
Gelman Instrument Co.
Immunology · 21d
Cleared Oct 18, 1977
CHOLESTEROL
K771833 · CGO
Gamma Enterprises, Inc.
Chemistry · 27d
Cleared Oct 18, 1977
UROFLOW-CYSTOMETER SYSTEM
K771850 · FAP
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 19d
Cleared Oct 18, 1977
FOLHY CATHETER
K771860 · EZL
Polysil, Inc.
Gastroenterology & Urology · 18d
Cleared Oct 18, 1977
AUTOMATED SLIDE SPINNER
K771898 · GKJ
Dynatech Cryomedical Co.
Hematology · 12d
Cleared Oct 18, 1977
VAPOR 19
K771899 · CAD
Draeger Medical, Inc.
Anesthesiology · 12d
Cleared Oct 14, 1977
125 I DIGOXIN RIA KIT
K771525 · DPB
Diagnostic Products Corp.
Toxicology · 67d
Cleared Oct 14, 1977
CURITY PEAKOMETER
K771655 · FFG
Kendall Research Center
Gastroenterology & Urology · 46d
Cleared Oct 14, 1977
CLINICARD CREATININE CHEMISTRY
K771773 · CGX
Harleco
Chemistry · 25d
Cleared Oct 14, 1977
PTH RIA
K771783 · CEW
Nichols Institute Diagnostics
Immunology · 21d
Cleared Oct 13, 1977
ID BRACLETS, ADULT & INFANT
K771158 · LDR
Divers-A-Med
General Hospital · 108d