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
4273–4296 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 23, 2013
SPACELABS HEALTHCARE CARDIOEXPRESS
K130207 · DPS
Spacelabs Healthcare, Ltd.
Cardiovascular · 176d
Cleared Jul 22, 2013
MICRO AMBULATORY ECG RECORDER
K131572 · DPS
Dimetek Digital Medical Technologies,...
Cardiovascular · 52d
Cleared Jul 22, 2013
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K131306 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 76d
Cleared Jul 22, 2013
RHYTHMIA MAPPING SYSTEM
K130750 · DQK
Rhythmia Medical, Inc.
Cardiovascular · 125d
Cleared Jul 19, 2013
CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
K131332 · DYB
Cardiosolutions, Inc.
Cardiovascular · 71d
Cleared Jul 19, 2013
IHEALTH CLOUD
K131203 · DXN
Andon Health Co, Ltd.
Cardiovascular · 81d
Cleared Jul 19, 2013
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
K130079 · MUD
Reflectance Medical, Inc.
Cardiovascular · 186d
Cleared Jul 18, 2013
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
K131327 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 71d
Cleared Jul 18, 2013
CENTRIMAG PRIMARY CONSOLE (2ND GENERATION)
K131179 · DWA
Thoratec Corp
Cardiovascular · 84d
Cleared Jul 18, 2013
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE...
K131046 · JOW
Venous Health Systems, Inc.
Cardiovascular · 94d
Cleared Jul 17, 2013
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K130766 · DQX
Cook, Inc.
Cardiovascular · 119d
Cleared Jul 16, 2013
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · QEZ
Medtronic, Inc.
Cardiovascular · 137d
Cleared Jul 15, 2013
TRUSCOPE SERIES PATIENT MONITOR
K131763 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 28d
Cleared Jul 15, 2013
EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION...
K131382 · MWI
Invivo Corporation
Cardiovascular · 62d
Cleared Jul 15, 2013
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
K130360 · DRG
Constant Care, LLC
Cardiovascular · 152d
Cleared Jul 11, 2013
CLINICAL ALERT NOTIFICATION
K130339 · MSX
Extension , Inc.
Cardiovascular · 150d
Cleared Jul 11, 2013
HEARTSINE SAMARITAN PAD 350P
K123881 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 206d
Cleared Jul 10, 2013
DLP CORONARY OSTIAL PERFUSION CANNULAE
K131269 · DWF
Medtronic, Inc.
Cardiovascular · 68d
Cleared Jul 10, 2013
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA...
K130391 · LOX
Boston Scientific Corp
Cardiovascular · 145d
Cleared Jul 08, 2013
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
K131463 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 48d
Cleared Jul 08, 2013
AMBIO REMOTE HEALTH MONITORING SYSTEM
K130676 · DRG
Arrayent Health, LLC D/B/A Ambio Health
Cardiovascular · 118d
Cleared Jul 05, 2013
ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE...
K131666 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 28d
Cleared Jul 03, 2013
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
K131786 · MWI
Airstrip Technologies, LP
Cardiovascular · 15d
Cleared Jul 03, 2013
CP150 ELECTROCARDIOGRAPH
K131573 · DPS
Welch Allyn, Inc.
Cardiovascular · 34d