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
1657–1680 of 18,110
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