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
149401–149424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1985
LS 5
K842037 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 294d
Cleared Mar 01, 1985
EKG TRANSMITTER MODEL 5134
K842051 · DXY
Instromedix, Inc.
Cardiovascular · 283d
Cleared Mar 01, 1985
CALCULATING CUFF INFLATOR TD312
K842067 · DXN
D. E. Hokanson, Inc.
Cardiovascular · 282d
Cleared Mar 01, 1985
ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD
K842514 · DRX
Multi Biosensors, Inc.
Cardiovascular · 248d
Cleared Mar 01, 1985
ACCUTORR CSM SYSTEM
K842538 · DXN
Datascope Corp.
Cardiovascular · 246d
Cleared Mar 01, 1985
MONITORING SYSTEM M720
K842944 · DPS
Burdick Corp.
Cardiovascular · 219d
Cleared Mar 01, 1985
BRENTWOOD EZ SCAN 200 AMBULATORY ECG
K842976 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 214d
Cleared Mar 01, 1985
EDEC-100
K843443 · IZO
Electromed Intl., Ltd.
Radiology · 178d
Cleared Mar 01, 1985
DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER
K844037 · LLZ
Toshiba Medical Systems
Radiology · 136d
Cleared Mar 01, 1985
TOMOGRAPHIC GANTRY
K844218 · IYX
General Electric Co.
Radiology · 121d
Cleared Mar 01, 1985
ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM
K844298 · LLZ
Adac Laboratories
Radiology · 122d
Cleared Mar 01, 1985
HEAD-SPINE STABILIZER HSS-1
K844549 · IWY
Imaging Accessories, Inc.
Radiology · 100d
Cleared Mar 01, 1985
OSMOLARITY STANDARDS
K844589 · JMZ
Rna Medical Corp.
Chemistry · 95d
Cleared Mar 01, 1985
IMA-TROL IMMUNOASSAY CONTROL
K844848 · JJY
Dimension Diagnostics
Chemistry · 78d
Cleared Mar 01, 1985
RICO RS4-XP EMERGENCY MEDICAL ASPIRATOR
K844881 · GCX
Rico Suction Laboratories, Inc.
General Hospital · 74d
Cleared Mar 01, 1985
RICO RS-6X EMERGENCY MEDICAL ASPIRATOR
K844882 · GCX
Rico Suction Laboratories, Inc.
General Hospital · 74d
Cleared Mar 01, 1985
ACOUSTIC OTOCOPE RECORDER
K850007 · ETY
Endeco Medical, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 01, 1985
KOTEX MAXI PADS
K850033 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 57d
Cleared Mar 01, 1985
KOTEX THIN MAXI PADS
K850034 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 57d
Cleared Mar 01, 1985
ECG PATIENT MONITOR 302
K850155 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 45d
Cleared Mar 01, 1985
ECG PATIENT MONITOR 301
K850156 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 45d
Cleared Mar 01, 1985
PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL
K850207
Syncor Intl. Corp.
Radiology · 42d
Cleared Mar 01, 1985
ABBOTT RF EIA DIAGNOSTIC KIT
K850373 · DHR
Abbott Laboratories
Chemistry · 29d
Cleared Mar 01, 1985
LDH REAGENT FOR DEMAND ANALYZER
K850378 · CFJ
Advanced Biomedical Methods, Inc.
Chemistry · 29d