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
505–528 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 20, 2025
VitalFlow Console
K250199 · QNR
Medtronic, Inc.
Cardiovascular · 117d
Cleared May 16, 2025
Embosphere Microspheres
K250971 · KRD
Biosphere Medical, S.A.
Cardiovascular · 46d
Cleared May 16, 2025
iBSM
K243837 · DRG
Iorbit Digital Technologies Private...
Cardiovascular · 154d
Cleared May 15, 2025
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186 · LDF
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared May 15, 2025
Nitinol Enhanced Device (NED)
K250276 · KRD
Embolization, Inc.
Cardiovascular · 104d
Cleared May 15, 2025
Hypertension Prediction Index (HePI) Algorithm
K242518 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 265d
Cleared May 14, 2025
Symphony™ Thrombectomy System
K250775 · QEW
Imperative Care, Inc.
Cardiovascular · 61d
Cleared May 12, 2025
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
K250592 · OWQ
Northeast Scientific, Inc.
Cardiovascular · 74d
Cleared May 12, 2025
InThrill™ Thrombectomy System
K250421 · QEW
Inari Medical, Inc.
Cardiovascular · 88d
Cleared May 09, 2025
VeriSight Intracardiac Echocardiography Catheter (VSICE2D)
K251103 · OBJ
Philips Image Guided Therapy Corporation
Cardiovascular · 28d
Cleared CT May 09, 2025
Volta AF-Xplorer
K243812 · DQK
Volta Medical
Cardiovascular · 149d
Cleared May 09, 2025
Avidhrt Sense SpO2
K241086 · DQA
Avidhrt, Inc.
Cardiovascular · 385d
Cleared May 05, 2025
Telemetry Monitor 5500 Release 4.0 (867232)
K242962 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 222d
Cleared May 02, 2025
Wrist Blood Pressure Monitor (AOJ-35A)
K250161 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 101d
Cleared May 02, 2025
Shockwave CS Guide Catheter
K243757 · DQY
Shockwave Medical, Inc.
Cardiovascular · 147d
Cleared May 02, 2025
AT-Patch (ATP-C130/ATP-C70)
K242583 · DSH
Atsens Co., Ltd.
Cardiovascular · 245d
Cleared May 01, 2025
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,...
K251007 · DXF
Circa Scientific, Inc.
Cardiovascular · 30d
Cleared Apr 30, 2025
AuST Steerable Sheath
K251051 · DYB
CenterPoint Systems, LLC
Cardiovascular · 27d
Cleared Apr 30, 2025
Arm Blood Pressure Monitor (ARM-30A+)
K244000 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 125d
Cleared Apr 30, 2025
Arctic Sun Stat Temperature Management System
K243942 · DWJ
Medivance, Inc.
Cardiovascular · 131d
Cleared Apr 25, 2025
Prelude Wave Hydrophilic Sheath Introducer
K250909 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Apr 25, 2025
FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere...
K250723 · MCW
Cardio Flow Inc.,
Cardiovascular · 46d
Cleared Apr 25, 2025
Amulet™ Steerable Delivery Sheath
K250426 · DQY
Abbott Medical
Cardiovascular · 70d
Cleared Apr 24, 2025
Arm Blood Pressure Monitor (ARM-30H)
K250116 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 98d