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
3841–3864 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 10, 2014
Direxion Torqueable Microcatheter
K142259 · KRA
Boston Scientific Corp
Cardiovascular · 27d
Cleared Sep 09, 2014
FRIMAP ADAPTER CONNECTOR (MAC)
K142182 · MTD
Topera, Inc.
Cardiovascular · 32d
Cleared Sep 09, 2014
ECARE COORDINATOR (ECC)
K141706 · DRG
Visicu, Inc.
Cardiovascular · 77d
Cleared Sep 09, 2014
SPACELABS HEALTHCARE TELEMETRY RECEIVER
K141156 · MHX
Spacelabs Healthcare
Cardiovascular · 127d
Cleared Sep 08, 2014
HD BLOOD PRESSURE MONITOR
K141924 · DXN
Biocare Asia Corporation , Ltd.
Cardiovascular · 54d
Cleared Sep 05, 2014
ELI 380 ELECTROCARDIOGRAPH
K142105 · DPS
Mortara Instrument, Inc.
Cardiovascular · 35d
Cleared Sep 04, 2014
HYDRAVIEW GUIDEWIRE
K141831 · DQX
Brivant Limited
Cardiovascular · 59d
Cleared Sep 03, 2014
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 89d
Cleared Sep 03, 2014
VDRIVE WITH V-LOOP/ VDRIVE DUO
K140804 · DXX
Stereotaxis, Inc.
Cardiovascular · 156d
Cleared Sep 02, 2014
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
K140874 · DXQ
Shanghai Goahui Rubber and Plastic...
Cardiovascular · 151d
Cleared Aug 29, 2014
MEMO 3D ReChord
K142221 · KRH
Sorin Group Italia S.R.L.
Cardiovascular · 17d
Cleared Aug 29, 2014
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
K132943 · DRC
Synaptic Medical Limited
Cardiovascular · 344d
Cleared Aug 27, 2014
CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER...
K140338 · DYB
Creganna-Tactx Medical
Cardiovascular · 198d
Cleared Aug 27, 2014
JETSTREAM XC 2.4/3.4
K133023 · MCW
Medrad, Inc.
Cardiovascular · 335d
Cleared Aug 22, 2014
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR
K141083 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 116d
Cleared Aug 22, 2014
1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER,...
K140944 · MCW
Atheromed, Inc.
Cardiovascular · 130d
Cleared Aug 21, 2014
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
K141521 · LIT
Boston Scientific Corporation
Cardiovascular · 73d
Cleared Aug 21, 2014
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
K140028 · DYB
Galt Medical Corp.
Cardiovascular · 227d
Cleared Aug 18, 2014
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
K141769 · DQO
Lightlab Imaging, Inc.
Cardiovascular · 48d
Cleared Aug 18, 2014
PHYSIOGLOVE ET SYSTEM
K133703 · DXH
Commwell R&D , Ltd.
Cardiovascular · 258d
Cleared Aug 15, 2014
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
K141951 · DWF
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 15, 2014
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
K141090 · LOX
Medtronic, Inc.
Cardiovascular · 109d
Cleared Aug 15, 2014
ALIVECOR HEART MONITOR
K140933 · DXH
AliveCor, Inc.
Cardiovascular · 126d
Cleared Aug 14, 2014
TEMPUS PRO WITH ENHANCED FEATURES
K133973 · QYW
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 231d