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
4249–4272 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 12, 2013
PHILIPS SURESIGNS CENTRAL
K131032 · MHX
Philips Medical Systems
Cardiovascular · 122d
Cleared Aug 09, 2013
INTEL-GE CARE INNOVATIONS CONNECT RCM
K130821 · DRG
Intel-Ge Care Innovations, LLC
Cardiovascular · 137d
Cleared Aug 08, 2013
PTS-X SIZING BALLOON CATHETER
K131869 · MJN
NuMED, Inc.
Cardiovascular · 45d
Cleared Aug 06, 2013
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X...
K131450 · LOX
Ostial Corporation
Cardiovascular · 78d
Cleared Aug 05, 2013
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
K132190 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 21d
Cleared Aug 02, 2013
SIDEKICK AND USHER SUPPORT CATHETERS
K131493 · DQY
C.R. Bard, Inc.
Cardiovascular · 71d
Cleared Aug 01, 2013
CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
K131079 · DYB
Creganna Medical Devices
Cardiovascular · 106d
Cleared Aug 01, 2013
CARDIO VISION MICS AORTIC CLAMPS
K123571 · DXC
Cardiomedical GmbH
Cardiovascular · 254d
Cleared Jul 30, 2013
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT,...
K132008 · DTD
Medtronic, Inc.
Cardiovascular · 29d
Cleared Jul 30, 2013
MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM
K124000 · DRG
Medapps Inc., Dba Alere Connect
Cardiovascular · 216d
Cleared Jul 30, 2013
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
K122458 · DRG
Cello Partnership D/B/A Verizon Wireless
Cardiovascular · 351d
Cleared Jul 29, 2013
MERIT HYDROPHILIC GUIDE WIRE
K131710 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 48d
Cleared Jul 29, 2013
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
K131361 · DWJ
Covidien
Cardiovascular · 77d
Cleared Jul 29, 2013
PTFE SUPER SHEATH INTRODUCER
K130855 · DYB
Martech Medical Products
Cardiovascular · 123d
Cleared Jul 29, 2013
ANGIOJET ULTRA POWER PULSE KIT
K130381 · QEW
Medrad, Inc.
Cardiovascular · 165d
Cleared Jul 26, 2013
SEER 1000
K130785 · MWJ
Getemed Medizin- Und...
Cardiovascular · 127d
Cleared Jul 26, 2013
VDRIVE W/V-SONO
K122659 · DQX
Stereotaxis, Inc.
Cardiovascular · 329d
Cleared Jul 25, 2013
SENSIS, SENSIS LITE
K131812 · DQK
Siemens Medi Cal Solutions, Inc.
Cardiovascular · 36d
Cleared Jul 24, 2013
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K131964 · DWA
Medtronic, Inc.
Cardiovascular · 27d
Cleared Jul 24, 2013
HEM-6131
K131742 · DXN
Omron Healthcare, Inc.
Cardiovascular · 41d
Cleared Jul 24, 2013
SAM JUNCTIONAL TOURNIQUET
K131561 · DXC
Sam Medical Products
Cardiovascular · 55d
Cleared Jul 24, 2013
EDWARDS EMBOL-X INTRODUCER SHEATH
K123714 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 232d
Cleared Jul 23, 2013
SORIN CONNECT DATA MANAGEMENT SYSTEM
K131816 · DXJ
Sorin Group Deutschland GmbH
Cardiovascular · 33d
Cleared Jul 23, 2013
NIGHTINGALE MONITORING SYSTEM
K130740 · MWI
Zoe Medical, Inc.
Cardiovascular · 126d