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: Cardiovascular ×
18,110 results
1993–2016 of 18,110
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 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 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