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
2905–2928 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 28, 2017
CardioCel 3D
K170951 · PSQ
Admedus Regen Pty, Ltd.
Cardiovascular · 28d
Cleared Apr 28, 2017
van Andel Dilatation Catheter
K170616 · DRE
Cook Incorporated
Cardiovascular · 58d
Cleared Apr 28, 2017
IOB Temperature Management System
K162679 · DWJ
Iob Medical, Inc.
Cardiovascular · 214d
Cleared Apr 28, 2017
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
K161596 · DQO
AngioDynamics, Inc.
Cardiovascular · 323d
Cleared Apr 24, 2017
ECG Disposable Lead Wire
K170536 · DSA
APK Technology Co., Ltd.
Cardiovascular · 60d
Cleared Apr 21, 2017
Nexxis OR, Nexxis
K170537 · DXJ
Barco N.V.
Cardiovascular · 57d
Cleared Apr 21, 2017
CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless...
K163255 · DXN
Caretaker Medical, LLC
Cardiovascular · 151d
Cleared Apr 20, 2017
HEM-9210T
K163235 · DXN
Omron Healthcare, Inc.
Cardiovascular · 154d
Cleared Apr 20, 2017
BeneVision Central Monitoring System
K162607 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 213d
Cleared Apr 18, 2017
Plato MICROCATH 27B Microcatheter
K170406 · DQO
Scientia Vascular, LLC
Cardiovascular · 67d
Cleared Apr 18, 2017
Finapres Nova Noninvasive Hemodynamic Monitor
K160967 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 377d
Cleared Apr 14, 2017
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry...
K163381 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 134d
Cleared Apr 07, 2017
Spectranetics Turbo-Elite Laser Atherectomy Catheters
K170059 · MCW
Spectranetics, Inc.
Cardiovascular · 91d
Cleared Apr 07, 2017
RX Takeru Balloon Dilatation Catheter
K163372 · LOX
KANEKA Corporation
Cardiovascular · 127d
Cleared Apr 06, 2017
Inqwire Diagnostic Guide Wire
K170700 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Apr 06, 2017
MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension...
K163233 · DQY
Mivi Neuroscience, Inc.
Cardiovascular · 140d
Cleared Apr 06, 2017
AcQGuide Steerable Sheath
K162925 · DRA
Acutus Medical, Inc.
Cardiovascular · 169d
Cleared Apr 05, 2017
HeartSpan Steerable Sheath Introducer
K170668 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Apr 05, 2017
Arm automatic blood pressure monitor
K161712 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 288d
Cleared Apr 04, 2017
ER-REBOA Catheter
K170411 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 53d
Cleared Apr 04, 2017
Nihon Kohden Vital Sign Telemeter
K163459 · MHX
Nihon Kohden Corporation
Cardiovascular · 116d
Cleared Apr 03, 2017
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire...
K163426 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 118d
Cleared Mar 31, 2017
BioMonitor 2-AF, BioMonitor 2-S
K170628 · MXD
Biotronik, Inc.
Cardiovascular · 29d
Cleared Mar 31, 2017
SureSigns VS3
K163649 · DSJ
Philips Medical Systems
Cardiovascular · 98d