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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
77977–78000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2001
C3 ANTERIOR CERVICAL PLATE SYSTEM
K012881 · KWQ
Spine Vision, Inc.
Orthopedic · 90d
Cleared Nov 26, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013075 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Nov 26, 2001
ANEURYSM CLIPS
K013136 · HCH
Gistlstrasse
Neurology · 68d
Cleared Nov 26, 2001
RAPIDONE-ECSTASY TEST
K013180 · DJC
American Bio Medica Corp.
Toxicology · 63d
Cleared Nov 26, 2001
BACTI-SWAB DRY
K013711 · LIO
Remel Co.
Microbiology · 19d
Cleared Nov 26, 2001
LIVESURE METHADONE SCREEN TESTS
K013796 · DJR
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Nov 21, 2001
STENT SUPPORT GUIDE CATHETER
K010579 · DQY
Medtronic Vascular
Cardiovascular · 267d
Cleared Nov 21, 2001
RUSCH BRONCHUS BLOCKER KIT
K010596 · CBI
Rusch Intl.
Anesthesiology · 266d
Cleared Nov 21, 2001
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
K011328 · LOS
Bionet Company, Ltd.
Cardiovascular · 204d
Cleared Nov 21, 2001
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4
K011487 · DXZ
Somanetics Corp.
Cardiovascular · 190d
Cleared Nov 21, 2001
RENAL GUIDING SHEATH
K012854 · DYB
Terumo Medical Corp.
Cardiovascular · 89d
Cleared Nov 21, 2001
HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
K012877 · EJT
Ivoclar USA, Inc.
Dental · 86d
Cleared Nov 21, 2001
CARTO XP EP NAVIGATION SYSTEM
K013083 · DQK
Biosense Webster, Inc.
Cardiovascular · 68d
Cleared Nov 21, 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
K013546 · HWC
Bionx Implants, Inc.
Orthopedic · 28d
Cleared Nov 21, 2001
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K013564 · DPS
Cambridge Heart, Inc.
Cardiovascular · 26d
Cleared Nov 21, 2001
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K013565 · DPS
Cambridge Heart, Inc.
Cardiovascular · 26d
Cleared Nov 20, 2001
INFUSION IV SET
K001879 · LRS
Nirvi Intl. USA
General & Plastic Surgery · 518d
Cleared Nov 20, 2001
SEREINE EXTRA STRENGTH DAILY CLEANER
K011561 · LPN
Wilsa, Inc.
Ophthalmic · 183d
Cleared Nov 20, 2001
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963 · CFR
Bayer Corp.
Chemistry · 151d
Cleared Nov 20, 2001
'RAPIDONE'-METHADONE TEST
K012164 · DJR
American Bio Medica Corp.
Toxicology · 132d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
K012817 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
K012818 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
LERMAN & SON CRANIAL ORTHOSIS HELMET
K012830 · MVA
Lerman & Son
Neurology · 89d
Cleared Nov 20, 2001
DUO PAL 6, ORDER-NO.: 2154
K012841 · EJS
Wieland Edelmetalle GmbH & Co.
Dental · 89d