FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
166201–166224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 08, 1980
MYELOSTAT DORSAL CORD STIMULATOR, ETC.
K801384 · GZB
Medtronic Vascular
Neurology · 27d
Cleared Jul 08, 1980
AMERLEX DIGOXIN RIA KIT
K801413 · LCS
Amersham Corp.
Toxicology · 22d
Cleared Jul 08, 1980
SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.
K801422 · LCP
Sandare Chemical Co., Inc.
Hematology · 21d
Cleared Jul 08, 1980
CONTROL SYRINGE
K801430 · FMF
Abco Dealers, Inc.
General Hospital · 21d
Cleared Jul 08, 1980
HEMOPEXIN NEPHELOMETRIC ASSAY
K801432 · CZX
J.T. Baker Chemical Co.
Immunology · 20d
Cleared Jul 08, 1980
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K801433 · DAD
J.T. Baker Chemical Co.
Immunology · 20d