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
132169–132192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1989
WRIGHT-GLEMSA STAIN
K890673 · IAF
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Feb 24, 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
K890674 · IAF
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Feb 24, 1989
MELANOCYTE GROWTH MEDIUM (MGM)
K890700 · KIT
Clonetics Corp.
Pathology · 14d
Cleared Feb 24, 1989
ENDOTHELIAL GROWTH MEDIUM (EGM)
K890701 · KIT
Clonetics Corp.
Pathology · 14d
Cleared Feb 23, 1989
KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR
K874778 · LMA
Eastman Kodak Company
Radiology · 462d
Cleared Feb 23, 1989
DRENOVAC
K883982 · GCY
Iberhospitex, S.A.
General & Plastic Surgery · 156d
Cleared Feb 23, 1989
CNS-8200A CENTRAL NURSES STATION
K884050 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 150d
Cleared Feb 23, 1989
HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI
K884087 · LOS
Marquette Electronics, Inc.
Cardiovascular · 149d
Cleared Feb 23, 1989
PATIENT MONITOR MODEL 701
K884096 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 148d
Cleared Feb 23, 1989
THYROXINE MICROASSAY
K884260 · KLI
Diamedix Corp.
Chemistry · 135d
Cleared Feb 23, 1989
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
K884550 · JHY
Bd Becton Dickinson Vacutainer...
Chemistry · 115d
Cleared Feb 23, 1989
DSL 7800 ACTIVE CORTISOL
K884689 · CGR
Diagnostic Systems Laboratories, Inc.
Chemistry · 107d
Cleared Feb 23, 1989
TECA/MEDELEC 'CONCEPT' P420
K884870 · GWF
Teca, Inc.
Neurology · 94d
Cleared Feb 23, 1989
BP-408 MARK II
K884885 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 93d
Cleared Feb 23, 1989
BP-308 MARK II
K884896 · DPS
Colin Medical Instruments Corp.
Cardiovascular · 93d
Cleared Feb 23, 1989
JEDMED KP6 COLPOSCOPE
K884934 · HEX
Jedmed Instrument Co.
Obstetrics & Gynecology · 87d
Cleared Feb 23, 1989
VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER
K884949 · EJK
Ortho Source
Dental · 90d
Cleared Feb 23, 1989
Q750 ELECTROCARDIOGRAPH
K885000 · LOS
Quinton, Inc.
Cardiovascular · 84d
Cleared Feb 23, 1989
SIEMENS INTRAVAGINAL TRANSDUCER
K885061 · HEM
Siemens Medical Solutions USA, Inc.
Obstetrics & Gynecology · 79d
Cleared Feb 23, 1989
HEARTSTART 2000 DEFIBRILLATION ELECTRODE
K885186 · LDD
Laerdal Mfg. Corp.
Cardiovascular · 71d
Cleared Feb 23, 1989
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
K885198 · JLX
Icn Biomedicals, Inc.
Chemistry · 69d
Cleared Feb 23, 1989
NUPREP
K885306 · DRX
Weaver & Co.
Cardiovascular · 58d
Cleared Feb 23, 1989
TITAN GEL ALKALINE PHOSPHATASE (HR)
K885341 · CIN
Helena Laboratories
Chemistry · 57d
Cleared Feb 23, 1989
BIOTRACK APTT CONTROLS
K890051 · GIT
Biotrack, Inc.
Hematology · 48d