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
1441–1464 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 11, 2022
Micro Catheter and Guidewire System
K212719 · KRA
Suzhou Hengrui Hongyuan Medical Co.,...
Cardiovascular · 227d
Cleared Apr 08, 2022
Prestige Coil System
K220699 · KRD
Bait USA, LLC
Cardiovascular · 29d
Cleared CT Apr 08, 2022
Fitbit Irregular Rhythm Notifications
K212372 · QDB
Fitbit, Inc.
Cardiovascular · 252d
Cleared Apr 07, 2022
Electrocardiograph
K212278 · DPS
Edan Instruments, Inc.
Cardiovascular · 261d
Cleared Apr 06, 2022
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
K220654 · NTE
Cordis Corporation
Cardiovascular · 30d
Cleared Apr 06, 2022
Prodigy Thrombectomy System
K214114 · QEW
Truvic Medical, Inc.
Cardiovascular · 97d
Cleared Apr 04, 2022
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
K213388 · QEZ
AngioDynamics, Inc.
Cardiovascular · 172d
Cleared CT Apr 01, 2022
DEEPVESSEL FFR
K213657 · PJA
Keyamed Na, Inc.
Cardiovascular · 133d
Cleared Apr 01, 2022
Aveir Retrieval Catheter
K213494 · MMX
Abbott Medical
Cardiovascular · 151d
Cleared Apr 01, 2022
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
K213490 · MHX
Ge Medical Systems Information...
Cardiovascular · 151d
Cleared Apr 01, 2022
Intri24 Sheath
K212392 · DYB
Inari Medical, Inc.
Cardiovascular · 242d
Cleared Mar 31, 2022
PhasTIPP
K212894 · DWQ
LeMaitre Vascular, Inc.
Cardiovascular · 202d
Cleared Mar 30, 2022
CareTaker Monitor App
K213699 · DXN
Caretaker Medical, LLC
Cardiovascular · 127d
Cleared Mar 25, 2022
Artix Thrombectomy Device
K220600 · QEW
Inari Medical
Cardiovascular · 23d
Cleared Mar 25, 2022
LE-12CH
K220362 · DPS
Caf Medical Solutions, Inc.
Cardiovascular · 45d
Cleared Mar 25, 2022
Biobeat Platform, BB-613WP Patch
K212153 · DQA
Biobeat Technologies , Ltd.
Cardiovascular · 259d
Cleared Mar 24, 2022
Emerge Monorail PTCA Dilatation Catheter
K220629 · LOX
Boston Scientific
Cardiovascular · 20d
Cleared Mar 24, 2022
Steth IO Spot
K220196 · DQD
Stratoscientific
Cardiovascular · 59d
Cleared Mar 24, 2022
Dib UltraNav Transseptal Catheter System
K213492 · DYB
Dib Ultranav Medical, LLC
Cardiovascular · 143d
Cleared Mar 24, 2022
Alio Medical Remote Monitoring System
K211365 · DRG
Graftworx, Inc. Dba Alio
Cardiovascular · 324d
Cleared Mar 23, 2022
Pounce Thrombectomy System
K220501 · QEW
Surmodics,Inc.
Cardiovascular · 29d
Cleared Mar 23, 2022
PathBuilder Transseptal Guiding Introducer
K212626 · DYB
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 217d
Cleared Mar 23, 2022
PathBuilder Transseptal Needle
K212625 · DRC
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 217d
Cleared Mar 21, 2022
Solus Gold Embolization Device
K213200 · KRD
Artio Medical, Inc.
Cardiovascular · 173d