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
6769–6792 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 08, 2006
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
K061848 · MUD
Hypermed, Inc.
Cardiovascular · 131d
Cleared Nov 03, 2006
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
K062999 · DQE
Hospira, Inc.
Cardiovascular · 32d
Cleared Nov 03, 2006
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA
K062597 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 63d
Cleared Nov 03, 2006
VOYAGER 12
K062469 · DPS
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 71d
Cleared Nov 03, 2006
EQUIVITAL, MODEL EQ-01
K061993 · MHX
Hidalgo Limited
Cardiovascular · 112d
Cleared Oct 30, 2006
MEDLOG, MODEL 1-0-10
K060756 · MWI
Bmc Gesellschaft Fur Medizintechnik Mbh
Cardiovascular · 223d
Cleared Oct 27, 2006
EP-WORKMATE
K063113 · DQK
Ep Medsystems
Cardiovascular · 16d
Cleared Oct 27, 2006
INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0
K062068 · DPS
Intelwave, LLC
Cardiovascular · 98d
Cleared Oct 26, 2006
MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
K062887 · DTK
Bard Peripheral Vascular
Cardiovascular · 30d
Cleared Oct 25, 2006
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69,...
K061416 · DQY
Medtronic Vascular
Cardiovascular · 156d
Cleared Oct 25, 2006
AMBU BLUE SENSOR NEO AND NEO X
K053550 · DRX
Ambu A/S
Cardiovascular · 309d
Cleared Oct 25, 2006
AMBU WHITE SENSOR CFM, CFL
K052944 · DRX
Ambu A/S
Cardiovascular · 370d
Cleared Oct 23, 2006
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
K062446 · DYB
Terumo Medical Corp.
Cardiovascular · 62d
Cleared Oct 23, 2006
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K061188 · MCW
Foxhollow Technologies, Inc.
Cardiovascular · 178d
Cleared Oct 20, 2006
TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02
K062870 · NFA
Kensey Nash Corp.
Cardiovascular · 25d
Cleared Oct 20, 2006
MODIFICATION TO GLIDESHEATH
K062858 · DYB
Terumo Medical Corp.
Cardiovascular · 25d
Cleared Oct 20, 2006
REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
K062251 · DRF
St Jude Medical
Cardiovascular · 78d
Cleared Oct 20, 2006
OCCLUSION BALLOON
K062202 · DQY
Boston Scientific Corp
Cardiovascular · 80d
Cleared Oct 18, 2006
ADMIRAL XTREME PTA CATHETER
K062809 · DQY
Invatec Innovative Technologies
Cardiovascular · 29d
Cleared Oct 17, 2006
FOX SV PTA CATHETER
K062843 · LIT
Abbott Laboratories
Cardiovascular · 25d
Cleared Oct 16, 2006
DMS 300-2, 300-3 AND 300-4
K062959 · MWJ
Diagnostic Monitoring Software
Cardiovascular · 17d
Cleared Oct 16, 2006
SERENO ELECTRONIC STETHOSCOPE
K062481 · DQD
Pishon High Tech Co., Ltd.
Cardiovascular · 53d
Cleared Oct 16, 2006
CONFIDANT 2.0
K062215 · DRG
Confidant, Inc.
Cardiovascular · 76d
Cleared Oct 16, 2006
PMP4 APPLICATION
K061428 · MSX
Card Guard Scientific Survival , Ltd.
Cardiovascular · 146d