FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
14641–14664 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 30, 1985
VIRATEK SMALL PARTICLE AEROSOL GENERAT
K843717
Viratek, Inc.
Cardiovascular · 465d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165
K852457 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145
K852458 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175
K852459 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115
K852653 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 24, 1985
LPA-1 PRESSURE MONITOR
K854022
Life Products, Inc.
Cardiovascular · 85d
Cleared Dec 24, 1985
MEDTRONIC PERMANENT LEAD INTRODUCER
K854559 · DYB
Medtronic Vascular
Cardiovascular · 40d
Cleared Dec 19, 1985
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
K854919 · DXY
Cook Pacemaker Corp.
Cardiovascular · 10d
Cleared Dec 18, 1985
BRONCHIAL CYTOLOGY BRUSH
K853667
E-Z-Em, Inc.
Cardiovascular · 106d
Cleared Dec 17, 1985
THE CALIFORNIA SPLINT
K854752 · DXQ
Intl. Medication Systems, Ltd.
Cardiovascular · 21d
Cleared Dec 16, 1985
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED
K854045 · DTZ
American Bentley
Cardiovascular · 75d
Cleared Dec 11, 1985
PRESSURE TRIGGER MOD OF SMEC INTRA-AORT
K840367 · DSP
Smec, Inc.
Cardiovascular · 684d
Cleared Dec 11, 1985
CARDIORATER CR 51
K853673 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 98d
Cleared Dec 11, 1985
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
K853950 · DTL
American Bentley
Cardiovascular · 77d
Cleared Dec 11, 1985
PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE
K853987 · DTM
Pall Biomedical Products Co.
Cardiovascular · 75d
Cleared Dec 09, 1985
MEDILOG M6
K852892 · DSI
Oxford Medilog, Inc.
Cardiovascular · 153d
Cleared Dec 09, 1985
CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90
K853072 · DYB
Camino Laboratories, Inc.
Cardiovascular · 139d
Cleared Dec 09, 1985
ATRIUM PLASMA TFE SYNTHETIC ARTERY
K853725 · DSY
Atrium Medical Corp.
Cardiovascular · 94d
Cleared Dec 09, 1985
LIFEPAK 8 MODIFICATION
K853732 · DRO
Physio-Control Corp.
Cardiovascular · 94d
Cleared Dec 09, 1985
NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000
K853791 · DTR
Norton Performance Plastics Corp.
Cardiovascular · 89d
Cleared Dec 09, 1985
POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD
K854069 · DTB
Intermedics, Inc.
Cardiovascular · 66d
Cleared Dec 04, 1985
CARDIAC COMMUNICATOR 2000
K852654 · DSI
Creative Medical, Inc.
Cardiovascular · 163d
Cleared Dec 04, 1985
IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A
K852710 · DTB
Telectronics, Inc.
Cardiovascular · 161d
Cleared Dec 04, 1985
CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA
K853294 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 110d