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
3913–3936 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 30, 2014
DUAL SHOT ALPHA 7
K133189 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 256d
Cleared Jun 27, 2014
DEVON CIRONA 6200 DVT
K141578 · JOW
Devon Medical
Cardiovascular · 14d
Cleared Jun 27, 2014
A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR
K141179 · DXN
A & D Co., Ltd.
Cardiovascular · 51d
Cleared Jun 27, 2014
SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER
K133843 · LIT
Cordis Corporation
Cardiovascular · 191d
Cleared Jun 26, 2014
SURESIGNS VS3, SURESIGNS VS4
K133961 · DSJ
Philips Medical Systems
Cardiovascular · 184d
Cleared Jun 25, 2014
MASIMO ROOT MONITORING SYSTEM
K140188 · MWI
Masimo Corporation
Cardiovascular · 152d
Cleared Jun 23, 2014
NOVOPRESS
K131416 · JOW
Milka, LLC
Cardiovascular · 403d
Cleared Jun 18, 2014
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
K141313 · KRD
Reverse Medical Corporation
Cardiovascular · 29d
Cleared Jun 18, 2014
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES
K140583 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 104d
Cleared Jun 18, 2014
QARDIOARM
K140067 · DXN
Qardio, Inc.
Cardiovascular · 159d
Cleared Jun 13, 2014
740 SELECT
K140430 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 114d
Cleared Jun 13, 2014
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
K140312 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 126d
Cleared Jun 12, 2014
TRIPLEPLAY PRO
K141360 · JOW
Wildcat Medical, Inc.
Cardiovascular · 20d
Cleared Jun 12, 2014
AFFINITY PIXIE OXYGENATION SYSTEM WITH
K141233 · DTN
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 12, 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE,...
K140695 · DQX
Medtronic, Inc.
Cardiovascular · 85d
Cleared Jun 11, 2014
CONTRAST MODULATION SYSTEM
K140425 · DXT
Osprey Medical, Inc.
Cardiovascular · 112d
Cleared Jun 11, 2014
DIGITAL ELECTROCARDIOGRAPH
K131858 · DPS
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 352d
Cleared Jun 10, 2014
PCD 737A
K140642 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 90d
Cleared Jun 06, 2014
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
K141185 · DQK
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 06, 2014
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
K141060 · PAW
On-X Life Technologies, Inc.
Cardiovascular · 43d
Cleared Jun 06, 2014
ENSITE VELOCITY SYSTEM
K141050 · DQK
St Jude Medical
Cardiovascular · 44d
Cleared Jun 06, 2014
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING...
K140972 · LDF
Medtronic, Inc.
Cardiovascular · 51d
Cleared Jun 06, 2014
AXERA 2 ACCESS SYSTEM
K140871 · DYB
Arstasis, Inc.
Cardiovascular · 63d
Cleared Jun 06, 2014
BIOMONITOR
K132960 · MXD
Biotronik, Inc.
Cardiovascular · 259d