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
6121–6144 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 03, 2008
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
K082646 · DQY
Usci Ireland
Cardiovascular · 53d
Cleared Oct 31, 2008
MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
K083135 · DWJ
Thermogear, Inc.
Cardiovascular · 8d
Cleared Oct 31, 2008
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
K082981 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 25d
Cleared Oct 31, 2008
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K082305 · DTK
C.R. Bard, Inc.
Cardiovascular · 79d
Cleared Oct 31, 2008
NEURON DELIVERY CATHETER 070
K082290 · DQY
Penumbra, Inc.
Cardiovascular · 81d
Cleared Oct 31, 2008
BP LIMBO XL, BPTANGO XL, BP SALSA XL
K072752 · DQK
Datadancer Medical Systems
Cardiovascular · 400d
Cleared Oct 29, 2008
APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K083021 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 20d
Cleared Oct 29, 2008
PINNACLE ROII INTRODUCER SHEATH
K082847 · DYB
Terumo Medical Corp.
Cardiovascular · 30d
Cleared Oct 29, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP...
K082357 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 72d
Cleared Oct 29, 2008
FLOWMEDICA BENEPHIT INFUSION SYSTEMS
K082163 · KRA
Flowmedica, Inc.
Cardiovascular · 90d
Cleared Oct 28, 2008
VTI INTRAOPERATIVE DOPPLER SYSTEMS
K082870 · DPW
Vascular Technology Incorporated
Cardiovascular · 29d
Cleared Oct 27, 2008
KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
K083043 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 13d
Cleared Oct 24, 2008
MULLINS-X, MODEL 250X
K082868 · DQY
NuMED, Inc.
Cardiovascular · 25d
Cleared Oct 23, 2008
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
K082139 · DXZ
Edwards Lifesciences, LLC
Cardiovascular · 86d
Cleared Oct 22, 2008
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
K082812 · MWI
Omron Healthcare, Inc.
Cardiovascular · 28d
Cleared Oct 20, 2008
HYPERQ SYSTEM
K082564 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 46d
Cleared Oct 20, 2008
DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
K080854 · DXQ
Suntech Medical, Inc.
Cardiovascular · 207d
Cleared Oct 17, 2008
NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I,...
K082599 · DXN
Cnsystem Medizintechnik AG
Cardiovascular · 39d
Cleared Oct 17, 2008
SPIRALFUSE PERIPHERAL INFUSION SYSTEM
K082199 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 74d
Cleared Oct 17, 2008
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
K081438 · DXZ
Lifenet Health
Cardiovascular · 148d
Cleared Oct 15, 2008
PRELUDE SHORT SHEATH INTRODUCER
K082063 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 86d
Cleared Oct 15, 2008
FLOWPICC CONSOLE
K081626 · OBJ
Vasonova, Inc.
Cardiovascular · 127d
Cleared Oct 14, 2008
PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE...
K081793 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 111d
Cleared Oct 10, 2008
PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
K082959 · DSA
Unimed Medical Supplies, Inc.
Cardiovascular · 7d