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
889–912 of 18,182
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