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
8641–8664 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 25, 2001
AUTOPULSE, MODEL 100
K011046 · DRM
Revivant Corp.
Cardiovascular · 202d
Cleared Oct 25, 2001
VENODYNE DVT ADVANTAGE PLUS
K011318 · JOW
Microtek Medical, Inc.
Cardiovascular · 177d
Cleared Oct 25, 2001
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K012141 · DRN
External Counterpulsation Lab
Cardiovascular · 107d
Cleared Oct 24, 2001
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
K011056 · QEW
Arrow Intl., Inc.
Cardiovascular · 201d
Cleared Oct 24, 2001
24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
K012143 · DRA
Medtronic Cardiac Surgical Products
Cardiovascular · 106d
Cleared Oct 23, 2001
TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII
K011058 · DXN
Meridian Medical Technologies , Ltd.
Cardiovascular · 200d
Cleared Oct 23, 2001
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · DXN
Health & Life Co., Ltd.
Cardiovascular · 43d
Cleared Oct 23, 2001
MODIFICATION TO BRAIDED GUIDING INTRODUCER
K013202 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 28d
Cleared Oct 19, 2001
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K013156 · MSX
Data Critical Corp.
Cardiovascular · 28d
Cleared Oct 18, 2001
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · JOW
Sterilmed, Inc.
Cardiovascular · 309d
Cleared Oct 17, 2001
VANGUARD REPROCESSED COMPRESSION GARMENT
K012403 · JOW
Vanguard Medical Concepts, Inc.
Cardiovascular · 79d
Cleared Oct 12, 2001
INSTRUMENT DAMPING PORT
K011373 · DRC
Medcanica, Inc.
Cardiovascular · 161d
Cleared Oct 12, 2001
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE...
K012206 · DQK
Cambridge Heart, Inc.
Cardiovascular · 91d
Cleared Oct 12, 2001
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
K012218 · DRO
The Ludlow Company LP
Cardiovascular · 88d
Cleared Oct 12, 2001
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
K012404 · DRO
Katecho, Inc.
Cardiovascular · 74d
Cleared Oct 10, 2001
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
K012263 · DPS
National Custom Ent., Inc.
Cardiovascular · 84d
Cleared Oct 10, 2001
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
K012264 · DPS
National Custom Ent., Inc.
Cardiovascular · 84d
Cleared Oct 09, 2001
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
K010954 · DQY
Concentric Medical, Inc.
Cardiovascular · 193d
Cleared Oct 09, 2001
SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515
K013029 · DYB
St Jude Medical
Cardiovascular · 29d
Cleared Oct 05, 2001
INTERCOSTAL LOCKABLE-DIRECTABLE PORT
K011349 · DRC
Medcanica, Inc.
Cardiovascular · 156d
Cleared Oct 04, 2001
MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
K004001 · DTZ
Dideco
Cardiovascular · 282d
Cleared Oct 04, 2001
C. NET 2100
K010396 · MLO
Cardionetics, Ltd.
Cardiovascular · 237d
Cleared Oct 04, 2001
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950 · DXT
Medrad, Inc.
Cardiovascular · 30d
Cleared Oct 03, 2001
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
K012336 · DSI
Medical Data Electronics
Cardiovascular · 71d