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
5209–5232 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 02, 2011
SPAULDING IQ ELECTROCARDIOGRAPH
K110065 · DPS
Spaulding Clinical Research, LLC
Cardiovascular · 51d
Cleared Mar 02, 2011
INPECTRA STO2 SPOT CHECK
K103613 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 83d
Cleared Mar 02, 2011
BLOOD PRESSURE CUFF
K102825 · DXQ
APK Technology Co., Ltd.
Cardiovascular · 154d
Cleared Mar 01, 2011
DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010
K101876 · DPS
Shenzhen Biocare Electronics Co., Ltd.
Cardiovascular · 238d
Cleared Mar 01, 2011
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
K101569 · DPS
Taidoc Technology Corporation
Cardiovascular · 270d
Cleared Feb 25, 2011
ENDOLOGIX GUIDEWIRE
K110241 · DQX
Techdevice Corporation
Cardiovascular · 29d
Cleared Feb 25, 2011
APPROACH PRO ST WIRE GUIDE
K110163 · DQX
Cook Incorporated
Cardiovascular · 37d
Cleared Feb 25, 2011
HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
K102532 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 175d
Cleared Feb 25, 2011
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM
K102482 · LIT
Ostial Corporation
Cardiovascular · 179d
Cleared Feb 25, 2011
FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
K100799 · DYB
Contract Medical Intl. GmbH
Cardiovascular · 340d
Cleared Feb 24, 2011
FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH
K110193 · DXC
St. Jude Medical Systems AB
Cardiovascular · 31d
Cleared Feb 23, 2011
ASCOM CLINICALCONNEX CARDIOMAX
K103634 · MSX
Ascom (Us), Inc.
Cardiovascular · 72d
Cleared Feb 23, 2011
EBONY PTA .035 PERIPHERAL DILATATION CATHETER
K103354 · LIT
Natec Medical , Ltd.
Cardiovascular · 99d
Cleared Feb 23, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931
K102939 · DXN
Andon Health Co, Ltd.
Cardiovascular · 142d
Cleared Feb 18, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110330 · DXN
Andon Health Co, Ltd.
Cardiovascular · 15d
Cleared Feb 18, 2011
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K110167 · DQE
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Feb 18, 2011
SYNTHES SCOUT VESSEL GUARD
K103558 · OMR
Synthes Spine
Cardiovascular · 78d
Cleared Feb 18, 2011
VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
K103260 · OBJ
Vasonova, Inc.
Cardiovascular · 106d
Cleared Feb 18, 2011
VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
K103255 · OBJ
Vasonova, Inc.
Cardiovascular · 107d
Cleared Feb 18, 2011
INFINITY CNAP SMARTPOD
K102968 · DXN
Draeger Medical Systems, Inc.
Cardiovascular · 135d
Cleared Feb 18, 2011
ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
K102206 · DPS
Mortara Instrument, Inc.
Cardiovascular · 197d
Cleared Feb 17, 2011
ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
K110168 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 28d
Cleared Feb 17, 2011
ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
K110154 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 29d
Cleared Feb 16, 2011
CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
K103678 · DQK
Ge Medical Systems Information...
Cardiovascular · 62d