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
7105–7128 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 16, 2005
ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350
K052727 · DXN
Rossmax International , Ltd.
Cardiovascular · 78d
Cleared Dec 16, 2005
READMYHEART, MODEL RMH2.0
K052303 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 114d
Cleared Dec 16, 2005
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
K052160 · DSI
Welch Allyn, Inc.
Cardiovascular · 129d
Cleared Dec 16, 2005
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
K052081 · DWF
Estech, Inc.
Cardiovascular · 136d
Cleared Dec 16, 2005
MODEL 750E SERIES MONITOR
K051896 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 156d
Cleared Dec 14, 2005
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
K053011 · DRX
Bio Protech, Inc.
Cardiovascular · 49d
Cleared Dec 13, 2005
VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER
K052258 · DQY
Vascular Solutions, Inc.
Cardiovascular · 116d
Cleared Dec 08, 2005
MIRA-FLEX 18 MICROCATHETER
K052841 · KRA
Cook, Inc.
Cardiovascular · 62d
Cleared Dec 08, 2005
RESOLUTION ENDOVASCULAR SYSTEM
K052428 · QEY
Omnisonics Medical Technologies
Cardiovascular · 97d
Cleared Dec 07, 2005
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
K051513 · DYB
Bipore, Inc.
Cardiovascular · 188d
Cleared Dec 06, 2005
INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024,...
K052738 · KRA
Veinrx, Inc.
Cardiovascular · 67d
Cleared Dec 05, 2005
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
K052644 · DYB
St Jude Medical
Cardiovascular · 70d
Cleared Nov 30, 2005
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
K053083 · DPS
Datrix
Cardiovascular · 28d
Cleared Nov 30, 2005
ASAHI PTCA GUIDE WIRE
K052339 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 96d
Cleared Nov 25, 2005
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
K052578 · DTK
Bard Peripheral Vascular, Inc.
Cardiovascular · 66d
Cleared Nov 23, 2005
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL...
K052872 · DXN
Taidoc Technology Corporation
Cardiovascular · 43d
Cleared Nov 23, 2005
MREYE EMBOLIZATION COIL
K052834 · KRD
Cook, Inc.
Cardiovascular · 48d
Cleared Nov 23, 2005
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
K052257 · DQY
Vascular Solutions, Inc.
Cardiovascular · 97d
Cleared Nov 22, 2005
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
K053027 · MWI
Welch Allyn, Inc.
Cardiovascular · 26d
Cleared Nov 22, 2005
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
K052977 · DQK
Ge Healthcare
Cardiovascular · 29d
Cleared Nov 22, 2005
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
K052784 · DXN
Welch Allyn, Inc.
Cardiovascular · 50d
Cleared Nov 22, 2005
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
K052524 · DWF
Medtronic Perfusion Systems
Cardiovascular · 69d
Cleared Nov 21, 2005
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
K052381 · DTL
Zerusa Limited
Cardiovascular · 83d
Cleared Nov 18, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT...
K052961 · DRG
Philips Medical Systems
Cardiovascular · 28d