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: Cardiovascular ×
18,182 results
2065–2088 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 24, 2020
Reprocessed Achieve Catheter Connecting Cable
K193263 · NLH
Innovative Health, LLC
Cardiovascular · 59d
Cleared Jan 24, 2020
KardiaMobile, KardiaStation
K191406 · DXH
AliveCor, Inc.
Cardiovascular · 241d
Cleared Jan 24, 2020
CARESCAPE B450
K191249 · MHX
GE Healthcare Finland Oy
Cardiovascular · 260d
Cleared Jan 23, 2020
Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
K192092 · DXN
Seca GmbH & Co. KG
Cardiovascular · 171d
Cleared Jan 21, 2020
TrapIt
K191229 · DQY
Imds Operations B.V.
Cardiovascular · 258d
Cleared Jan 21, 2020
CARESCAPE B650
K191149 · MHX
GE Healthcare Finland Oy
Cardiovascular · 266d
Cleared Jan 17, 2020
AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
K193509 · DYB
Acutus Medical, Inc.
Cardiovascular · 30d
Cleared Jan 17, 2020
Merit ONE Snare System
K193507 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared CT Jan 17, 2020
Study Watch with Irregular Pulse Monitor
K192415 · DXH
Verily Life Sciences, LLC
Cardiovascular · 135d
Cleared Jan 17, 2020
SoundBite Console, SoundBite Active Wire 18
K192211 · PDU
Soundbite Medical Solution, Inc.
Cardiovascular · 156d
Cleared Jan 17, 2020
SureLead Cable System
K181089 · DSA
Authentic Medical
Cardiovascular · 632d
Cleared CT Jan 15, 2020
Wattson Temporary Pacing Guidewire
K192454 · DQX
Vascular Solutions
Cardiovascular · 128d
Cleared Jan 15, 2020
Eko Analysis Software
K192004 · MWI
Eko Devices, Inc.
Cardiovascular · 173d
Cleared Jan 15, 2020
All’InCath 035M PTA Balloon Dilatation Catheter
K191275 · LIT
Nexstep Medical
Cardiovascular · 247d
Cleared Jan 15, 2020
VitalScan ANS
K191266 · JOM
Medeia, Inc.
Cardiovascular · 250d
Cleared Jan 10, 2020
FlowMet
K192966 · DPW
Laser Associated Sciences, Inc.
Cardiovascular · 79d
Cleared Jan 10, 2020
KardioScreen
K191692 · DPS
Imedrix Inc. (Formerly Piitech Inc.)
Cardiovascular · 199d
Cleared Jan 09, 2020
ER-REBOA PLUS Catheter
K193440 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 29d
Cleared Jan 07, 2020
BioCardia 8F Morph DNA Deflectable Guide Catheter
K192774 · DQY
Biocardia
Cardiovascular · 99d
Cleared Jan 07, 2020
VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
K191870 · DRG
VivaLNK, Inc.
Cardiovascular · 179d
Cleared Jan 06, 2020
R2P Destination Slender Guiding Sheath
K193125 · DYB
Terumo Medical Corporation
Cardiovascular · 55d
Cleared Jan 02, 2020
ASAHI PTCA Guide Wire ASAHI Gaia Next
K192599 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 104d
Cleared Jan 02, 2020
OptoWire III
K191907 · DQX
Opsens, Inc.
Cardiovascular · 170d
Cleared Dec 31, 2019
Patient Monitor
K192343 · DQA
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 125d