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
1369–1392 of 18,110
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 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 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