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
673–696 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 27, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral...
K242213 · PPN
Shockwave Medical, Inc.
Cardiovascular · 60d
Cleared Sep 27, 2024
AMC Health CareConsole
K233446 · MWI
Amc Health
Cardiovascular · 344d
Not Cleared Sep 27, 2024
ShortCut
DEN240017 · SCZ
Pi-Cardia, Ltd.
Cardiovascular · 163d
Cleared Sep 26, 2024
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,...
K241414 · DXF
Circa Scientific, Inc.
Cardiovascular · 132d
Cleared Sep 26, 2024
BioButton System
K241101 · DRG
Biointellisense, Inc.
Cardiovascular · 157d
Cleared Sep 25, 2024
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K242075 · QEW
Penumbra, Inc.
Cardiovascular · 71d
Cleared Sep 24, 2024
Happy Ring Health Monitoring System
K240236 · MWI
Happy Health, Inc.
Cardiovascular · 239d
Cleared Sep 23, 2024
EchoGo Heart Failure (2.0)
K240013 · QUO
Ultromics Limited
Cardiovascular · 265d
Cleared Sep 20, 2024
HiCardi+ H100
K232670 · DSH
MEZOO Co., Ltd.
Cardiovascular · 385d
Cleared Sep 19, 2024
Stethophone
K240901 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 170d
Cleared Sep 18, 2024
Arrow® Nitinol Wire
K241784 · DQX
Teleflex Medical
Cardiovascular · 90d
Cleared Sep 17, 2024
Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
K241230 · DYB
Togo Medikit Co., Ltd.
Cardiovascular · 138d
Cleared Sep 14, 2024
Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology...
K241156 · NLH
Surgical Instrument Service and...
Cardiovascular · 141d
Cleared Sep 13, 2024
RT Carbon ECG Leads
K240087 · DSA
Ivy Biomedical Systems, Inc.
Cardiovascular · 246d
Cleared Sep 12, 2024
VitalFlow Set with Balance Biosurface
K240880 · QJZ
Medtronic, Inc.
Cardiovascular · 164d
Cleared CT Sep 12, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
K240787 · DQY
Biotronik, Inc.
Cardiovascular · 174d
Cleared Sep 12, 2024
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood...
K231982 · DTZ
Qura S.R.L
Cardiovascular · 435d
Cleared Sep 11, 2024
Pounce XL Thrombectomy System (PTS-1011-7F135)
K241362 · QEW
Surmodics,Inc.
Cardiovascular · 120d
Cleared Sep 10, 2024
Option ELITE Vena Cava Filter System (352506070E 352506100E)
K242612 · DTK
Argon Medical Devices, Inc.
Cardiovascular · 7d
Cleared Sep 10, 2024
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for...
K234064 · OWQ
Surgical Instrument Service and...
Cardiovascular · 263d
Cleared Sep 08, 2024
PM2 System and ECGuide Connector
K240486 · LJS
Piccolo Medical, Inc.
Cardiovascular · 201d
Cleared Sep 06, 2024
SafeCross Vascular Introducer System (4001)
K240600 · DYB
East End Medical I, LLC
Cardiovascular · 186d
Cleared Sep 06, 2024
Nordica PV Cryo Mapping Catheter
K233900 · DRF
Synaptic Medical Corporation
Cardiovascular · 270d
Cleared Sep 03, 2024
Indigo® Aspiration System – Aspiration Catheter 6X
K242319 · QEW
Penumbra, Inc.
Cardiovascular · 29d