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
152545–152568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1984
MAKS CENTRAL DELIVERY SYS-11-200 ETC
K840859 · KOC
Erika, Inc.
Gastroenterology & Urology · 88d
Cleared May 22, 1984
CENTAURI CT SCANNER
K840860 · JAK
Technicare Corp.
Radiology · 88d
Cleared May 22, 1984
AMRESCO E4A REAGENT SET
K840868 · JJE
American Research Products Co.
Chemistry · 85d
Cleared May 22, 1984
ELECTRO-PALATE
K840892 · ESE
Cisko Systems
Ear, Nose, Throat · 85d
Cleared May 22, 1984
LINEAR CLOUD TONOMETER
K841089 · LCH
Linear Tonometers, Inc.
Chemistry · 70d
Cleared May 22, 1984
TAGO DIFFU-GEN C-REACTIVE PROTEIN
K841265 · DCN
Tago, Inc.
Chemistry · 57d
Cleared May 22, 1984
C-17
K841268 · EBF
Pentron Corp.
Dental · 57d
Cleared May 22, 1984
C-19
K841269 · EBF
Pentron Corp.
Dental · 57d
Cleared May 22, 1984
GASTROSTOMY FEEDING TUBE
K841330 · KNT
Microvasive
Gastroenterology & Urology · 50d
Cleared May 22, 1984
SCOTTS TAP WATER SUBSTITUTE 7
K841423 · JCC
Reagent Laboratory, Inc.
Pathology · 47d
Cleared May 22, 1984
NUMBER 21 R/R SYSTEM
K841457 · KLE
Pentron Corp.
Dental · 43d
Cleared May 22, 1984
NUMBER 20 R/L SYSTEM
K841458 · KLE
Pentron Corp.
Dental · 43d
Cleared May 22, 1984
KODAK EKTACHEM DT 60 ANALYZER
K841503 · JJE
Eastman Kodak Company
Chemistry · 42d
Cleared May 22, 1984
CONCENTRATE CONDUCTIVITY METER
K841543 · FKQ
Renal Systems, Inc.
Gastroenterology & Urology · 36d
Cleared May 22, 1984
SIGMA PROCEDURE 16-UV
K841555 · CFR
Sigma Chemical Co.
Chemistry · 36d
Cleared May 22, 1984
ORTHO MICROWELL READER
K841557 · JJQ
Ortho Diagnostic Systems, Inc.
Chemistry · 36d
Cleared May 22, 1984
TECHNICON RA-1000 SYS T4-THYROXINE
K841576 · KLI
Technicon Instruments Corp.
Chemistry · 35d
Cleared May 22, 1984
SUN-LITE WHITE SPOT
K841588 · KYT
Suncoast Medical Manufacturers, Inc.
General Hospital · 34d
Cleared May 22, 1984
C-LITE
K841589 · KYT
Suncoast Medical Manufacturers, Inc.
General Hospital · 34d
Cleared May 22, 1984
STORZ UNIVERSAL EYE SHIELD
K841599 · HOY
Storz Instrument Co.
Ophthalmic · 34d
Cleared May 22, 1984
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601 · KLI
Terumo Medical Corp.
Chemistry · 34d
Cleared May 22, 1984
ACCURATE BETA 30 PREGNANCY TEST KIT
K841602 · LCX
Organon, Inc.
Chemistry · 34d
Cleared May 22, 1984
BLOOD SPOT NEONATAL TSH RADIOIMMUNO
K841606 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 33d
Cleared May 22, 1984
DUPONT THEOPHYLLINE ASSAY KIT
K841656 · KLS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 29d