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
4705–4728 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 29, 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K120459 · DYB
Oscor, Inc.
Cardiovascular · 135d
Cleared Jun 29, 2012
ANY VIEW PATIENT MONITORS
K120193 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 158d
Cleared Jun 29, 2012
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM...
K113775 · LOX
Ostial Corporation
Cardiovascular · 190d
Cleared Jun 29, 2012
ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA...
K113459 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 220d
Cleared Jun 27, 2012
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
K120780 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 105d
Cleared Jun 27, 2012
DATACAPTOR SYSTEM
K113835 · MWI
Capsule Tech, Inc.
Cardiovascular · 183d
Cleared Jun 26, 2012
GLIDER PTCA BALLOON CATHETER
K121681 · LOX
Trireme Medical, Inc.
Cardiovascular · 19d
Cleared Jun 22, 2012
HERO GRAFT
K121532 · DSY
Hemosphere, Inc.
Cardiovascular · 29d
Cleared Jun 22, 2012
TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
K121222 · LOX
Abbott Vascular
Cardiovascular · 60d
Cleared Jun 21, 2012
AXERA ACCESS SYSTEM
K121521 · DYB
Arstasis, Inc.
Cardiovascular · 29d
Cleared Jun 21, 2012
ZOLL PROPAQ XM
K121367 · MHX
ZOLL Medical Corporation
Cardiovascular · 45d
Cleared Jun 14, 2012
SUREFIRE HI-FLOW MICROCATHETER
K121677 · DQO
Surefire Medical, Inc.
Cardiovascular · 7d
Cleared Jun 14, 2012
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
K121470 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Jun 14, 2012
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451 · OCL
Medtronic, Inc.
Cardiovascular · 29d
Cleared Jun 14, 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K121442 · LIT
Cordis Corporation
Cardiovascular · 30d
Cleared Jun 14, 2012
VECTOR
K121385 · LIT
R4 Vascular, Inc.
Cardiovascular · 37d
Cleared Jun 14, 2012
KODAMA INTRAVASCULAR ULRASOUND CATHETER
K113008 · OBJ
Silicon Vally Medical Instruments, Inc.
Cardiovascular · 251d
Cleared Jun 13, 2012
EXPRESSION INFORMATION PORTAL
K121424 · MWI
Invivo Corporation
Cardiovascular · 30d
Cleared Jun 13, 2012
CONCIERGE GUIDING CATHETER
K121051 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 68d
Cleared Jun 12, 2012
RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU...
K121145 · JOW
Renu Medical, Inc.
Cardiovascular · 57d
Cleared Jun 12, 2012
AMPLATZER VASCULAR PLUG 4
K113658 · KRD
Aga Medical Corp.
Cardiovascular · 183d
Cleared Jun 12, 2012
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
K113628 · DXX
Catheter Robotics, Inc.
Cardiovascular · 187d
Cleared Jun 11, 2012
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION...
K113411 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 206d
Not Cleared Jun 11, 2012
NUCLEUS-X PTV CATHETER
DEN080015 · OZT
NuMED, Inc.
Cardiovascular · 1265d