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
1729–1752 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 26, 2021
Spacelabs Lifescreen PRO Analyzer
K201921 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 259d
Not Cleared Mar 26, 2021
Oxehealth Vital Signs
DEN200019 · QME
Oxehealth Limited
Cardiovascular · 364d
Cleared Mar 23, 2021
Aneroid Sphygmomanometer
K203620 · DXQ
Wuxi Exanovo Medical Instrument Co.,...
Cardiovascular · 102d
Cleared Mar 23, 2021
MyHomeDoc
K202483 · DQD
Myhomedoc , Ltd.
Cardiovascular · 207d
Cleared Mar 21, 2021
Movement and Compressions System (the MAC System)
K203052 · JOW
Recovery Force, LLC
Cardiovascular · 165d
Cleared Mar 11, 2021
WorkMate Claris System
K210392 · DQK
Abbott
Cardiovascular · 29d
Cleared Mar 10, 2021
FloPump 57mL Centrifugal Pump
K193663 · KFM
International Biophysics Corporation
Cardiovascular · 435d
Cleared Mar 09, 2021
Blood Pressure Monitor
K202891 · DXN
Guangdong Transtek Medical...
Cardiovascular · 162d
Cleared Mar 09, 2021
ZOLL Propaq M
K202375 · MWI
ZOLL Medical Corporation
Cardiovascular · 201d
Cleared Mar 07, 2021
Century Perfusion System
K202125 · DTQ
Century Hlm, LLC
Cardiovascular · 219d
Cleared Mar 06, 2021
CPR BAND
K201581 · LIX
Credo
Cardiovascular · 268d
Cleared Mar 05, 2021
SafeSept Blunt Needle
K210328 · DRC
Pressure Products Medical Device...
Cardiovascular · 29d
Cleared Mar 05, 2021
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K203261 · DRF
Innovative Health, LLC
Cardiovascular · 120d
Cleared Mar 05, 2021
NuVision ICE Catheter
K201775 · OBJ
Nuvera Medical, Inc.
Cardiovascular · 249d
Cleared Mar 04, 2021
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161,...
K210324 · DXC
Carefusion 2200, Inc.
Cardiovascular · 28d
Cleared Mar 04, 2021
MI DeTACH
K210006 · DXC
Biorep Technologies, Inc.
Cardiovascular · 59d
Cleared Mar 03, 2021
AtriClip LAA Exclusion System
K210293 · PZX
AtriCure, Inc.
Cardiovascular · 29d
Cleared Mar 03, 2021
WIRION Embolic Protection System
K210282 · NTE
Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Mar 03, 2021
FineCross M3
K203521 · DQY
Ashitaka Factory of Terumo Corporation
Cardiovascular · 92d
Cleared Mar 01, 2021
Recon Support Catheter
K203275 · DQY
C.R. Bard, Inc.
Cardiovascular · 115d
Not Cleared Mar 01, 2021
Analytic for Hemodynamic Instability (AHI)
DEN200022 · QNV
Fifth Eye, Inc.
Cardiovascular · 332d
Cleared Feb 28, 2021
QardioCore
K201644 · DSH
Qardio, Inc.
Cardiovascular · 256d
Cleared Feb 26, 2021
Indigo Aspiration System - Lightning Aspiration Tubing
K210323 · QEW
Penumbra, Inc.
Cardiovascular · 22d
Cleared Feb 26, 2021
Brite Tip Radianz Guiding Sheath
K202167 · DYB
Cordis Corporation
Cardiovascular · 207d