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
6433–6456 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 29, 2007
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
K072449 · DPS
Welch Allyn, Inc.
Cardiovascular · 90d
Cleared Nov 29, 2007
MOBIL-O-GRAPH NG 24 H ABP-CONTROL
K072446 · DXN
I.E.M. GmbH
Cardiovascular · 91d
Cleared Nov 29, 2007
PM-7000 PATIENT MONITOR
K072346 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 100d
Cleared Nov 29, 2007
CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH...
K072049 · DXN
Bmeye B.V.
Cardiovascular · 127d
Cleared Nov 21, 2007
PADNET+
K073146 · JOM
Biomedix, Inc.
Cardiovascular · 13d
Cleared Nov 21, 2007
VITALOGIK MODEL 4000/4500
K073140 · DSI
Mennen Medical , Ltd.
Cardiovascular · 14d
Cleared Nov 21, 2007
CTU676 DEVICE
K073013 · JOW
Compression Technologies Unlimited, Inc.
Cardiovascular · 27d
Cleared Nov 21, 2007
TWIN-PASS OTW CATHETER, MODEL 5201
K072618 · DQY
Vascular Solutions, Inc.
Cardiovascular · 65d
Cleared Nov 21, 2007
PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE
K072372 · JOW
Mego Afek
Cardiovascular · 90d
Cleared Nov 21, 2007
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S)...
K071655 · DSI
Medtronic, Inc.
Cardiovascular · 156d
Cleared Nov 21, 2007
REVEAL XT
K071641 · DSI
Medtronic, Inc.
Cardiovascular · 159d
Cleared Nov 21, 2007
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
K071521 · DWC
Terumo Cardiovascular Systems Corp.
Cardiovascular · 170d
Cleared Nov 21, 2007
FIDELITY 200 CARDIAC EVENT RECORDER
K071228 · DXH
Signalife, Inc.
Cardiovascular · 202d
Cleared Nov 20, 2007
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
K073035 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Nov 20, 2007
HEMOSTASIS VALVE
K072556 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 71d
Cleared Nov 19, 2007
MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
K072502 · DQK
Ge Medical Systems Information...
Cardiovascular · 74d
Cleared Nov 19, 2007
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE...
K072202 · DQK
Biosense Webster, Inc.
Cardiovascular · 103d
Cleared Nov 16, 2007
SKINTACT AND VARIOUS OTHER TRADENAMES
K073104 · DRX
Leonhard Lang GmbH
Cardiovascular · 14d
Cleared Nov 16, 2007
CONFIDANT 2.5
K072698 · DRG
Confidant, Inc.
Cardiovascular · 53d
Cleared Nov 15, 2007
A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE
K072593 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 62d
Cleared Nov 14, 2007
ANGIOJET ULTRA
K072769 · QEZ
Possis Medical, Inc.
Cardiovascular · 47d
Cleared Nov 14, 2007
ODYSSEY WORKSTATION
K072371 · DXX
Stereotaxis, Inc.
Cardiovascular · 83d
Cleared Nov 09, 2007
VASCUTRAK II PTA DILATATION CATHETER
K073025 · PNO
Thermopeutix, Inc. Dba Ymed, Inc.
Cardiovascular · 14d
Cleared Nov 09, 2007
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
K072748 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 43d