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
1345–1368 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 29, 2022
Next Generation NetKonnect
K220989 · MHX
Nihon Kohden Digital Health...
Cardiovascular · 116d
Cleared Jul 29, 2022
Bodyport Cardiac Scale
K211585 · DSB
Bodyport, Inc.
Cardiovascular · 431d
Cleared Jul 28, 2022
Biotres
K222017 · MWJ
Biotricity
Cardiovascular · 20d
Cleared Jul 27, 2022
BIOMONITOR IIIm, BIOMONITOR III
K221856 · MXD
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jul 27, 2022
CorPath GRX System
K221464 · DXX
Corindus, Inc.
Cardiovascular · 69d
Cleared Jul 27, 2022
Upper Arm Type Blood Pressure Monitor
K220886 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 121d
Cleared Jul 27, 2022
DeepRhythmAI
K210822 · DQK
Medicalgorithmics S.A.
Cardiovascular · 495d
Cleared Jul 22, 2022
MedWand
K212975 · MWI
Medwand Solutions, Inc.
Cardiovascular · 308d
Cleared Jul 19, 2022
Selectra Lead Implantation System
K222037 · DQY
Biotronik, Inc.
Cardiovascular · 8d
Cleared Jul 19, 2022
ZEUS System (Zio Watch)
K213409 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 273d
Cleared CT Jul 19, 2022
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular...
K213357 · DXH
Verily Life Sciences, LLC
Cardiovascular · 280d
Cleared Jul 19, 2022
Tiche PTA Balloon Dilatation Catheter
K212215 · LIT
Brosmed Medical Co., Ltd.
Cardiovascular · 369d
Cleared Jul 15, 2022
ers2 - ergoline Rehabilitation System
K212883 · DRG
Ergoline GmbH
Cardiovascular · 308d
Cleared Jul 14, 2022
AHI System
K221203 · QNV
Fifth Eye, Inc.
Cardiovascular · 79d
Cleared Jul 12, 2022
Protrieve Sheath
K220415 · QEW
Inari Medical, Inc.
Cardiovascular · 148d
Cleared Jul 12, 2022
N Series Patient Monitors
K213799 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 218d
Cleared Jul 11, 2022
Artix Ballon Guiding Sheath
K221846 · DQY
Inari Medical
Cardiovascular · 17d
Cleared Jul 07, 2022
medi pneumatic compression system (pcs)-genius (Model 652)
K221654 · JOW
Medi USA, LP
Cardiovascular · 30d
Cleared Jul 06, 2022
Oscar Peripheral Multifunctional Catheter system
K214038 · LIT
Biotronik, Inc.
Cardiovascular · 195d
Cleared Jul 01, 2022
AcQMap High Resolution Imaging and Mapping System
K220784 · DQK
Acutus Medical, Inc.
Cardiovascular · 106d
Cleared Jul 01, 2022
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
K220171 · QTF
Northeast Scientific, Inc.
Cardiovascular · 161d
Cleared Jul 01, 2022
GEM
K213385 · KRD
Obsidio, Inc.
Cardiovascular · 261d
Cleared Jul 01, 2022
CROSSLEAD Peripheral Guide Wire
K213315 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Jun 30, 2022
CPS AIM Universal II Slittable Inner Catheter
K221750 · DQY
Abbott Medical
Cardiovascular · 14d