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
313–336 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 19, 2025
Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
K251143 · DXN
Ningbo Ranor Medical Science &...
Cardiovascular · 249d
Cleared Dec 19, 2025
Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
K250314 · PNE
Surgical Instrument Service and...
Cardiovascular · 318d
Cleared Dec 18, 2025
Assert-IQ (DM5100)
K253516 · MXD
Abbott Medical
Cardiovascular · 36d
Cleared CT Dec 18, 2025
Helo Thrombectomy System
K252956 · QEW
Endovascular Engineering, Inc.
Cardiovascular · 93d
Cleared Dec 18, 2025
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1
K252533 · DQK
Edwards Lifesciences
Cardiovascular · 128d
Cleared Dec 18, 2025
Amethyst HP PTA OTW 0.035 Catheter
K251915 · LIT
Natec Medical , Ltd.
Cardiovascular · 178d
Cleared Dec 17, 2025
Intri26 Introducer Sheath
K252508 · DYB
Inari Medical, Inc.
Cardiovascular · 131d
Cleared Dec 17, 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417 · DQY
Abbott Medical
Cardiovascular · 138d
Cleared Dec 17, 2025
Multi-parameter Patient Monitor (N10)
K250854 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 271d
Cleared CT Dec 16, 2025
prolaio eVO2peak Module (Version 1.0)
K252204 · PPW
Prolaio, Inc.
Cardiovascular · 155d
Cleared Dec 16, 2025
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · DXQ
Baxter Healthcare Corporation
Cardiovascular · 193d
Cleared Dec 15, 2025
V•Stick™ Vascular Access Set
K253741 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 21d
Cleared Dec 15, 2025
Tembo Embolic System
K253677 · KRD
Instylla, Inc.
Cardiovascular · 24d
Cleared Dec 15, 2025
HyperVue™ Imaging System - Integrated
K253101 · NQQ
Spectrawave, Inc.
Cardiovascular · 82d
Cleared Dec 12, 2025
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 256d
Cleared Dec 12, 2025
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon...
K250821 · DTZ
Eurosets S.R.L
Cardiovascular · 269d
Cleared Dec 11, 2025
DeepRhythmAI
K253141 · DQK
Medicalgorithmics S.A.
Cardiovascular · 77d
Cleared CT Dec 08, 2025
HeartBeam AIMIGo with 12-L ECG Synthesis Software System
K250258 · DXH
Heartbeam, Inc.
Cardiovascular · 314d
Cleared Dec 08, 2025
Sequential Compression System (SCD600)
K250190 · JOW
Shenzhen Comen Medical Instruments...
Cardiovascular · 319d
Cleared Dec 05, 2025
MEMO Patch M (MPT-E08R-UNC01)
K243438 · DXH
Huinno Co., Ltd.
Cardiovascular · 394d
Cleared Dec 04, 2025
Vektor Computational ECG Mapping System (vMap®)
K252429 · DQK
Vektor Medical, Inc.
Cardiovascular · 125d
Cleared Dec 04, 2025
MitraPatch Mitral Valve Repair System
K252126 · PAW
Chawla Heart Technologies, LLC
Cardiovascular · 150d
Cleared Dec 01, 2025
IBP cable Becton Dickinson (2606488)
K252827 · DSA
Dr?gerwerk AG & Co KGaA
Cardiovascular · 87d
Cleared Nov 26, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional...
K252405 · NLH
Surgical Instrument Service and...
Cardiovascular · 118d