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

Filters: Cleared only ×
176,076 results
167041–167064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1980
NITRATE SWAB-RAPID TEST
K800803 · JXB
Remel Co.
Microbiology · 89d
Cleared Jul 08, 1980
HIPPUR-ASE TUBES
K800816 · JTO
Microchemical Specialities, Co.
Microbiology · 88d
Cleared Jul 08, 1980
AVL #980 ELECTROLYTE ANALYZER
K801011 · JGS
Gauntlet Technology Corp.
Chemistry · 74d
Cleared Jul 08, 1980
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-
K801020 · CFT
Travenol Laboratories, S.A.
Chemistry · 69d
Cleared Jul 08, 1980
ADAPTAID ELEMA LEAD ADAPTER KIT 365-17
K801038 · DTD
Intermedics, Inc.
Cardiovascular · 67d
Cleared Jul 08, 1980
MULTICOR (GAMMA) MODEL 336 & MODEL 337
K801106 · DXY
Cordis Corp.
Cardiovascular · 60d
Cleared Jul 08, 1980
COLLIMAX X-RAY COLLIMATOR # R-182
K801168 · IZX
Ito X-Ray Corp.
Radiology · 54d
Cleared Jul 08, 1980
ASO QUANTUM, ANTISTREPTOLYSIN O TEST
K801177 · GTQ
Sclavo, Inc.
Microbiology · 53d
Cleared Jul 08, 1980
REIGNING EPOXY RESIN CEMENT
K801236 · EMA
Oki Shiks USA , Ltd.
Dental · 42d
Cleared Jul 08, 1980
SERALYZER BLOOD UREA NITROGEN(BUN)
K801269 · JGZ
Miles Laboratories, Inc.
Chemistry · 41d
Cleared Jul 08, 1980
TEST FOR KETONE IN URINE(ACETOACETIC AC
K801270 · JIN
Miles Laboratories, Inc.
Chemistry · 41d
Cleared Jul 08, 1980
PORTA-NEB(R) 310
K801286 · BTI
E.B.E. Research & Mfg., Inc.
Anesthesiology · 39d
Cleared Jul 08, 1980
EC-4 PLETHYSMOGRAPH
K801291 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 36d
Cleared Jul 08, 1980
COBAS REAGENT FOR A-AMYLASE
K801295 · JFJ
Roche Analytical Instruments, Inc.
Chemistry · 36d
Cleared Jul 08, 1980
COBAS REAGENT FOR TRIGLYCERIDES & COBAS
K801298 · CDT
Roche Analytical Instruments, Inc.
Chemistry · 36d
Cleared Jul 08, 1980
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · JIW
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 36d
Cleared Jul 08, 1980
UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE
K801335 · JJY
Warner-Lambert Co.
Chemistry · 34d
Cleared Jul 08, 1980
DISPOSABLE ARTICULATOR
K801342 · EJP
Williams Gold Refining Co., Inc.
Dental · 33d
Cleared Jul 08, 1980
KAMPNER HINGED TOE PROSTHESIS
K801345 · KWH
Biomedics
Orthopedic · 32d
Cleared Jul 08, 1980
HEMORRHOIDAL LIGATION INSTR. SYSTEM
K801352 · FHN
Depuy, Inc.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS ARTERIAL/VENOUS FISTULA NEEDLE
K801354 · KOC
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
K801355 · KOC
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET
K801356 · KOC
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
CROWN DELTA SILICONE IMPRESSION MATERIAL
K801380 · ELW
Crown Delta Corp.
Dental · 27d