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
817–840 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 07, 2024
Teleport XT Microcatheter
K231608 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 219d
Cleared Jan 04, 2024
Pursuant Health Kiosk (G1.D5)
K230996 · DXN
Pursuant Health
Cardiovascular · 272d
Cleared Jan 04, 2024
Dayspring
K223228 · JOW
Koya Medical, Inc.
Cardiovascular · 443d
Cleared Dec 27, 2023
TriSalus TriGuideTM Guiding Catheter
K233858 · DQY
Trisalus Life Sciences
Cardiovascular · 22d
Cleared Dec 22, 2023
ElastiMed SACS
K232300 · JOW
Elastimed , Ltd.
Cardiovascular · 143d
Cleared Dec 22, 2023
CPM System
K231086 · MWI
Analog Devices, Inc.
Cardiovascular · 249d
Cleared Dec 21, 2023
Reusable Blood Pressure Cuff
K233276 · DXQ
Suzhou Minhua Medical Apparatus...
Cardiovascular · 83d
Cleared Dec 20, 2023
Blood Pressure Monitor
K233130 · DXN
Guangdong Transtek Medical...
Cardiovascular · 84d
Cleared Dec 20, 2023
Cogent™ Hemodynamic Monitoring System
K232048 · DXG
Icu Medical
Cardiovascular · 163d
Cleared Dec 20, 2023
HP PTA Balloon Dilatation Catheter
K231402 · LIT
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 219d
Cleared Dec 20, 2023
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
K231227 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 236d
Cleared Dec 19, 2023
GORE® ACUSEAL Vascular Graft
K233551 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 46d
Cleared Dec 19, 2023
JETi™Hydrodynamic Thrombectomy System
K232458 · QEZ
Abbott Medical
Cardiovascular · 126d
Cleared Dec 19, 2023
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850...
K231671 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 194d
Cleared Dec 18, 2023
ClotTriever Sheath
K233815 · QEW
Inari Medical, Inc.
Cardiovascular · 18d
Cleared Dec 17, 2023
FlexCath Cross Transseptal Solution
K233691 · DYB
Acutus Medical, Inc.
Cardiovascular · 31d
Cleared Dec 15, 2023
Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000),...
K233668 · MCW
Eximo Medical, Ltd.
Cardiovascular · 30d
Cleared Dec 15, 2023
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
K232130 · OWQ
Surgical Instrument Services and...
Cardiovascular · 151d
Cleared Dec 15, 2023
Digital Blood Pressure Monitor (Model: YB-800)
K231478 · DXN
Wenzhou Yosun Medical Technology Co.,Ltd
Cardiovascular · 207d
Cleared Dec 15, 2023
Cardio Q50, Cardio Q70
K231160 · DPS
Bionet Co., Ltd.
Cardiovascular · 238d
Cleared Dec 14, 2023
VersaCross Connect™ Transseptal Dilator
K233647 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 30d
Cleared Dec 14, 2023
MedHealth DVT compression Devices MHH900S/MHH900E
K231801 · JOW
Medhealth Medical Limited
Cardiovascular · 177d
Cleared Dec 13, 2023
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
K231870 · DQK
Ge Medical Systems Information...
Cardiovascular · 170d
Cleared Dec 12, 2023
Intri24 Introducer Sheath (52-101)
K233646 · DYB
Inari Medical, Inc.
Cardiovascular · 28d