Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
149977–150000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN
K850603 · DEB
Applications Lab
Immunology · 18d
Cleared Mar 05, 1985
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K850639 · CIW
Bio-Analytics Laboratories, Inc.
Chemistry · 14d
Cleared Mar 04, 1985
HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR
K844201 · FLL
Mallinckrodt Critical Care
General Hospital · 125d
Cleared Mar 04, 1985
FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES
K844346 · JHJ
Fisher Diagnostics
Chemistry · 115d
Cleared Mar 04, 1985
TROGIDE
K844696 · BTR
Carmel Medical Devices
Anesthesiology · 91d
Cleared Mar 04, 1985
CHLAMYDIAL TRANSPORT MEDIA
K850124 · JSM
Hillcrest Biologicals
Microbiology · 49d
Cleared Mar 04, 1985
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
K850159 · JHI
Hybritech, Inc.
Chemistry · 48d
Cleared Mar 04, 1985
DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU
K850191 · HPT
Bio-Rad
Ophthalmic · 45d
Cleared Mar 04, 1985
SUCTION REGULATOR 7700 SERIES
K850200 · KDP
Boehringer Laboratories
General Hospital · 45d
Cleared Mar 04, 1985
LEECO CONCEP-7-BHCG LEIAD II
K850201 · JHI
Leeco Diagnostics, Inc.
Chemistry · 45d
Cleared Mar 04, 1985
TERUMO SENSIBEAD EIA TSH KIT
K850376 · JLW
Terumo Medical Corp.
Chemistry · 32d
Cleared Mar 04, 1985
EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN
K850510 · KIT
Mediatech, Inc.
Microbiology · 24d
Cleared Mar 01, 1985
PHONOANGIOGRAPHIC SPECTRAL ANALYZER
K840169 · DPW
Biotronics Instruments
Cardiovascular · 410d
Cleared Mar 01, 1985
DISPOSABLE ECG ELECTRODE
K841944 · DRX
Bristol Medical Electronics Corp.
Cardiovascular · 294d
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