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
4129–4152 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 25, 2013
VALVED TEARAWAY INTRODUCER GENERATION II
K132498 · DYB
Medcomp (Medical Components, Inc.)
Cardiovascular · 108d
Cleared Nov 22, 2013
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133399 · MCW
Cardiovascular Systems Incorporated
Cardiovascular · 16d
Cleared Nov 22, 2013
V8 TRANSLUMINAL BAV CATHETER
K132728 · OZT
Intervalve, Inc.
Cardiovascular · 80d
Cleared Nov 22, 2013
PC ECG
K131819 · DPS
Edan Instruments, Inc.
Cardiovascular · 155d
Cleared Nov 22, 2013
SOFIA DISTAL ACCESS CATHETER
K131482 · DQY
MicroVention, Inc.
Cardiovascular · 183d
Cleared Nov 22, 2013
V-STICK VASCULAR ACCESS SET
K130730 · DYB
Argon Medical
Cardiovascular · 249d
Cleared Nov 20, 2013
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
K132808 · MWI
Welch Allyn, Inc.
Cardiovascular · 70d
Cleared Nov 20, 2013
WRIGHT GRADIENT 52 - TORSO
K131387 · JOW
Wright Therapy Products, Inc.
Cardiovascular · 190d
Cleared Nov 20, 2013
ISIRONA MAGELLAN
K130707 · MSX
Isirona, LLC
Cardiovascular · 250d
Cleared Nov 19, 2013
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
K132712 · KFM
Medtronic, Inc.
Cardiovascular · 82d
Cleared Nov 19, 2013
PARACE MD EKOSCOPE IS100
K123148 · DQD
Parace, LLC
Cardiovascular · 410d
Cleared Nov 15, 2013
TRANSGATE GUIDE CATHETER
K132542 · DQY
Stryker Neurovascular
Cardiovascular · 94d
Cleared Nov 15, 2013
ND NABIL DIB INFUSION CATHETER
K130569 · KRA
Translational Research Institute
Cardiovascular · 256d
Cleared Nov 14, 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K133208 · KRD
Boston Scientific Corp
Cardiovascular · 27d
Cleared Nov 14, 2013
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
K131778 · DSY
Maquet Cardiovascular, LLC
Cardiovascular · 150d
Cleared Nov 14, 2013
DIGITAL ELECTROCARDIOGRAPHS
K131262 · DPS
Sonoscape Company Limited
Cardiovascular · 195d
Cleared Nov 14, 2013
BOSCH BLOOD PRESSURE METER (BP5000 BT)
K131026 · DXN
Robert Bosch Healthcare Systems, Inc.
Cardiovascular · 216d
Cleared Nov 12, 2013
QUADROX-IR ADULT AND SMALL ADULT
K133265 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 20d
Cleared Nov 08, 2013
MEDIVALVE ACWIRE
K132545 · DQX
Medivalve , Ltd.
Cardiovascular · 87d
Cleared Nov 07, 2013
Merit ASAPLP Aspiration Catheter
K132155 · QEZ
Merit Medical Systems, Inc.
Cardiovascular · 118d
Cleared Nov 06, 2013
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
K132048 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 127d
Cleared Nov 06, 2013
LEMAITRE 8F OCCLUSION CATHETER
K132022 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 128d
Cleared Nov 05, 2013
LEMILLS VALVULOTOME
K132047 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 126d
Cleared Nov 05, 2013
CARDIOX FLOW DETECTION SYSTEM
K122400 · DXG
Cardiox Corp.
Cardiovascular · 455d