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
139081–139104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1987
THE WOOG ORABRUSH
K871406 · JEQ
Woog Intl.
Dental · 90d
Cleared Jul 07, 1987
HYPERFORMANCE CONTROLS (HP-CONTROLS)
K871694 · DIF
Rapid Diagnostic Laboratories, Inc.
Toxicology · 70d
Cleared Jul 07, 1987
UNI-FAST LACTATE DEHYDROGENASE (LDH-L)
K872030 · CFJ
Sclavo, Inc.
Chemistry · 42d
Cleared Jul 07, 1987
PARAMAX CHOLESTEROL REAGENT
K872050 · LBS
American Dade
Chemistry · 40d
Cleared Jul 07, 1987
HALL VEIN STRIPPER
K872157 · DWQ
Solco Basle, Inc.
Cardiovascular · 33d
Cleared Jul 07, 1987
KINETIC 610 ETHANOL
K872180 · DML
American Monitor Corp.
Toxicology · 29d
Cleared Jul 07, 1987
PEKALUX(TM)
K872243 · EBF
Columbus Dental Mfg. Co.
Dental · 26d
Cleared Jul 07, 1987
CORNING EASY WASH ELISA PLATES
K872273 · LIB
Corning Medical & Scientific
Chemistry · 22d
Cleared Jul 07, 1987
UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE)
K872303 · JJY
Vanguard Diagnostic Systems
Chemistry · 22d
Cleared Jul 07, 1987
UNASSAYED CONTROL SERUM, NORMAL (BOVINE)
K872304 · JJY
Vanguard Diagnostic Systems
Chemistry · 22d
Cleared Jul 07, 1987
DIGOXIN FPIA CALIBRATORS
K872328 · DLJ
Sigma Chemical Co.
Chemistry · 20d
Cleared Jul 07, 1987
DIGOXIN FPIA CONTROLS
K872347 · LAS
Sigma Diagnostics, Inc.
Toxicology · 20d
Cleared Jul 06, 1987
MICOR
K865010 · DQK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 195d
Cleared Jul 06, 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388 · LCP
Bio-Rad
Hematology · 90d
Cleared Jul 06, 1987
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
K872227 · JJY
Bio-Rad
Chemistry · 27d
Cleared Jul 06, 1987
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
K872360 · GHH
American Dade
Hematology · 18d
Cleared Jul 02, 1987
PLAK VAK - PV-10
K864540 · EFS
Paul S. Barclay, D.D.S. , Ltd.
Dental · 225d
Cleared Jul 02, 1987
GLUMA(TM) BONDING SYSTEM
K871164 · EBF
Columbus Dental Mfg. Co.
Dental · 100d
Cleared Jul 02, 1987
CLEARFIL PORCELAIN BOND
K871636 · KLE
Kuraray Co.
Dental · 66d
Cleared Jul 02, 1987
SPATULA, DENTAL, CEMENT
K871818 · EJB
Military Engineering, Inc.
Dental · 52d
Cleared Jul 02, 1987
COULTER COUNTER MODEL S-PLUS STKR
K871837 · GKZ
Coulter Electronics, Inc.
Hematology · 51d
Cleared Jul 02, 1987
XOMED PLATINUM WIRE TEFLON PISTION
K872112 · ETB
Xomed, Inc.
Ear, Nose, Throat · 31d
Cleared Jul 02, 1987
ABRASIVE DISC - POLISHING WHEEL
K872251 · EJR
Dentsply Intl.
Dental · 20d
Cleared Jul 02, 1987
PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS
K872272 · EBF
Columbus Dental Mfg. Co.
Dental · 20d