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
5497–5520 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 17, 2010
CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
K101523 · JOW
Devon Medical, Inc.
Cardiovascular · 15d
Cleared Jun 17, 2010
COAXIAL INTRODUCER SET
K101399 · DYB
Martech Medical Products
Cardiovascular · 30d
Cleared Jun 17, 2010
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
K101259 · MWI
Taidoc Technology Corporation
Cardiovascular · 44d
Cleared Jun 17, 2010
HASKAL TORQUE DEVICE
K100425 · DQX
Elcam Medical Acal
Cardiovascular · 121d
Cleared Jun 16, 2010
ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001
K101406 · QEZ
Medrad Interventional/Possis
Cardiovascular · 28d
Cleared Jun 11, 2010
ENSITE VELOCITY SYSTEM, MODEL EE3000
K101419 · DQK
St Jude Medical
Cardiovascular · 22d
Cleared Jun 11, 2010
JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE...
K101334 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 11, 2010
GENESIS DM MODEL: 6053000A1
K101242 · DRG
Honeywell Hommed, LLC
Cardiovascular · 39d
Cleared Jun 11, 2010
PATIENT MONITOR, MODEL PM50
K101127 · MWI
Contec Medical System Co., Ltd.
Cardiovascular · 50d
Cleared Jun 11, 2010
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K100129 · DRX
Ambu A/S
Cardiovascular · 143d
Cleared Jun 10, 2010
BLOOD PRESSURE METER, MODEL CH-4532
K093931 · DXN
Citizen Systems Japan Co., Ltd.
Cardiovascular · 170d
Cleared Jun 08, 2010
VITAL SIGNS MONITOR-VSM 6000 SERIES
K101445 · MWI
Welch Allyn, Inc.
Cardiovascular · 15d
Cleared Jun 08, 2010
A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200
K101002 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 57d
Cleared Jun 08, 2010
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
K100217 · MHX
Mediana Co., Ltd.
Cardiovascular · 134d
Cleared Jun 03, 2010
HOTDOG MULTI FUNCTION CONTROLLER
K094056 · DWJ
Augustine Biomedical & Design, LLC
Cardiovascular · 154d
Cleared Jun 03, 2010
CARECENTER MD
K093211 · DPS
Cardiac Science Corporation
Cardiovascular · 233d
Cleared Jun 03, 2010
AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270
K093102 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 245d
Cleared Jun 02, 2010
VIEWFLEX PLUS ICE CATHETER
K101239 · DQO
St Jude Medical
Cardiovascular · 30d
Cleared Jun 02, 2010
JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
K101221 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 02, 2010
HYDROFIX SURGICAL SHEET
K100905 · OMR
Mimedx Group, Inc.
Cardiovascular · 62d
Cleared May 28, 2010
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE...
K101275 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 22d
Cleared May 28, 2010
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
K100427 · DRG
Taidoc Technology Corporation
Cardiovascular · 101d
Cleared May 28, 2010
REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
K100254 · NLH
Ascent Healthcare Solutions
Cardiovascular · 120d
Cleared May 26, 2010
IQVITALS AND IQVITALS SYSTEM
K100913 · DXN
Brentwood Medical Technology Corp.
Cardiovascular · 55d