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
601–624 of 18,110
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 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