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
1273–1296 of 18,182
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