FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77377–77400 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 20, 2001
ZIPPY, MODEL I88WA
K012846 · ITI
Pillar Technology, Inc.
Physical Medicine · 89d
Cleared Nov 20, 2001
RESORBABLE SCREW ANCHOR
K012872 · HWC
Arthrotek, Inc.
Orthopedic · 85d
Cleared Nov 20, 2001
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
K012875 · LNH
GE Medical Systems
Radiology · 85d
Cleared Nov 20, 2001
THE BIOPLATE MANDIBLE FIXATION SYSTEM
K012910 · JEY
Bioplate, Inc.
Dental · 82d
Cleared Nov 20, 2001
POWER DRIVE
K012944 · EKX
Mediteam AB
Dental · 77d
Cleared Nov 20, 2001
BIOSCANNER 2000
K013068 · CGA
Polymer Technology Systems, Inc.
Chemistry · 145d
Cleared Nov 20, 2001
MEDSTAR 150
K013081 · IPF
Mednet Services, Inc.
Physical Medicine · 67d
Cleared Nov 20, 2001
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K013220 · LPL
Poly Vue Technolgies, Inc.
Ophthalmic · 55d