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
1201–1224 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 07, 2022
Eclipse MINI Model 98900
K212317 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 469d
Cleared Nov 03, 2022
ibiomedi Electronic Stethoscope ES-2020
K220466 · DQD
Sound Land Corp.
Cardiovascular · 259d
Cleared Nov 01, 2022
Current Health System
K222550 · MSX
Current Health , Ltd.
Cardiovascular · 70d
Cleared Oct 28, 2022
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
K220305 · PZX
Syntheon
Cardiovascular · 268d
Cleared Oct 28, 2022
Welch Allyn Connex Central Station
K212473 · MWI
Welch Allyn, Inc.
Cardiovascular · 448d
Cleared Oct 26, 2022
VASSALLO GT EXT
K222631 · DQX
Filmecc Co., Ltd.
Cardiovascular · 56d
Cleared Oct 24, 2022
KODEX – EPD™ System 1.5.0
K212493 · DQK
Philips Medical Systems Nederland,...
Cardiovascular · 441d
Cleared Oct 20, 2022
V-Patch Cardiac Monitor
K222842 · DXH
Shandong Corecare Technology Limited
Cardiovascular · 30d
Cleared Oct 20, 2022
PADnet Xpress
K220527 · JOM
Collaborative Care Diagnostics, LLC,...
Cardiovascular · 238d
Cleared Oct 20, 2022
eClinic Stethopod
K220099 · DQD
Homediagnostic, LLC
Cardiovascular · 281d
Cleared Oct 20, 2022
eWave Monitor
K214073 · DSH
Wearlinq, Inc.
Cardiovascular · 297d
Cleared Oct 20, 2022
Houdini Cross Support Catheter
K213466 · DQY
Cruzar Medsystems, Inc.
Cardiovascular · 357d
Cleared Oct 19, 2022
Vascu-Guard Vascular Repair Patch
K221032 · PSQ
Synovis Life Technologies, Inc.
Cardiovascular · 195d
Cleared Oct 19, 2022
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
K221029 · PSQ
Synovis Life Technologies, Inc.
Cardiovascular · 195d
Cleared Oct 18, 2022
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score...
K221986 · PNO
Transit Scientific, LLC
Cardiovascular · 104d
Cleared Oct 18, 2022
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
K221321 · DPS
Ge Medical Systems Information...
Cardiovascular · 165d
Cleared Oct 17, 2022
AcQMap High Resolution Imaging and Mapping System
K222209 · DQK
Acutus Medical, Inc.
Cardiovascular · 84d
Cleared Oct 17, 2022
YUWELL Electronic Blood Pressure Monitor
K221372 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 158d
Cleared Oct 14, 2022
Sublime Microcatheter
K221886 · DQY
Surmodics,Inc.
Cardiovascular · 107d
Cleared Oct 14, 2022
HeartFlow Analysis
K213857 · PJA
HeartFlow, Inc.
Cardiovascular · 308d
Cleared Oct 13, 2022
Abiomed 14Fr Low Profile Introducer Set
K222113 · DYB
Abiomed, Inc.
Cardiovascular · 87d
Cleared Oct 13, 2022
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer,...
K221857 · DXQ
Zhejiang Lude Technology Development...
Cardiovascular · 108d
Cleared Oct 12, 2022
Arm Blood Pressure Monitor
K221913 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 104d
Cleared Oct 12, 2022
AT-Patch ECG Analysis System
K203638 · DSH
Atsens Co., Ltd.
Cardiovascular · 667d