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
241–264 of 18,110
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 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 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 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