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
156193–156216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1983
EASYTOUCH BUN REAGENT SET
K832749 · CDQ
Worthington Diagnostic Systems
Chemistry · 60d
Cleared Oct 14, 1983
TOTAL IRON-BINDING CAPACITY ACCESORY
K832759 · JMO
Seragen Diagnostics, Inc.
Chemistry · 56d
Cleared Oct 14, 1983
RIA SOFTWARE
K832760 · JQP
Kemble Instruments, Inc.
Chemistry · 56d
Cleared Oct 14, 1983
REFEREE BLOOD GAS ANALYZER-ELECTRODES
K832779 · CHL
Analytical Products, Inc.
Chemistry · 59d
Cleared Oct 14, 1983
FLOW-PAC SHOLESTEROL REAGENT SET
K832780 · CHH
American Research Products Co.
Chemistry · 59d
Cleared Oct 14, 1983
COMPUR* EASY TOUCH URIC ACID REAGENT
K832785 · KNK
Worthington Diagnostic Systems
Chemistry · 59d
Cleared Oct 14, 1983
SERALYZER AST/SGOT REAGENT STRIPS
K832790 · CIF
Miles Laboratories, Inc.
Chemistry · 59d
Cleared Oct 14, 1983
SERAYZER ALT/SGPT REAGENT STRIPS
K832791 · CKC
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Oct 14, 1983
MODIFICA-OF EMIT AED PRIMIDONE ASSAY
K832798 · DJD
Syva Co.
Toxicology · 57d
Cleared Oct 14, 1983
MODIFICA- OF EMIT CAD LIDOCAINE ASSAY
K832799 · KLR
Syva Co.
Toxicology · 57d
Cleared Oct 14, 1983
URETERAL DILATION SET
K832808 · EZN
Van-Tec, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 14, 1983
FIAX IGG TEST
K832821 · DFI
Intl. Diagnostic Technology
Immunology · 56d
Cleared Oct 14, 1983
CLOSED SYS. DRAINAGE BAGS & TRAYS
K832822 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 14, 1983
ENZYMUNE-TEST TSH
K832823 · JLW
Icl Scientific
Chemistry · 56d
Cleared Oct 14, 1983
LIPASE HYDROLYSIS/GLYCEROL KINASE
K832871 · CDT
Pointe Scientific, Inc.,
Chemistry · 50d
Cleared Oct 14, 1983
HEXOKINASE, GLUCOSE
K832872 · CFR
Pointe Scientific, Inc.,
Chemistry · 50d
Cleared Oct 14, 1983
GOAL TENDER
K832878 · BWF
Dna Medical, Inc.
Anesthesiology · 49d
Cleared Oct 14, 1983
LUNDIA 10-2-L PARALLEL PLATE HEMODIALY
K832894 · KOC
Gambro, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 14, 1983
LEGIONELLA INDIRECT FLUORESCENT ANTIBOD
K832896 · LHL
Biodan Medical Systems, Ltd.
Immunology · 52d
Cleared Oct 14, 1983
ZIMMER OSSIMETER
K832899 · FTY
Zimmer, Inc.
General & Plastic Surgery · 46d
Cleared Oct 14, 1983
CEFUROXIME 30MCG. SENSITIVITY DISCS
K832909 · JTN
Difco Laboratories, Inc.
Immunology · 46d
Cleared Oct 14, 1983
URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN
K832915 · FAD
Surgitek
Gastroenterology & Urology · 46d
Cleared Oct 14, 1983
GRAVITY ENTERAL FEEDING SET
K832927 · KNT
Medical Connections
Gastroenterology & Urology · 51d
Cleared Oct 14, 1983
SHABAN #9852 CHIMNEY-#9854 SCREEN &
K832931 · JJO
Shaban Mfg. Co.
Chemistry · 45d