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
1273–1296 of 18,110
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 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