FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
11065–11088 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 01, 1994
IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
K940425 · MAV
Imagyn Medical, Inc.
Cardiovascular · 182d
Cleared Aug 01, 1994
ROSSMAX INTERNATIONAL LIMITED ACCURACY BLOOD PRESSURE MONITOR
K940620 · DXN
Quality Systems Design, Inc.
Cardiovascular · 168d
Cleared Aug 01, 1994
MICROVIEW II/MICRORAIL II CATHETERS
K942231 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Aug 01, 1994
FLO-RESTER DISPOSABLE VESSEL OCCLUDER
K942812 · DXC
Bio-Vascular, Inc.
Cardiovascular · 48d
Cleared Jul 27, 1994
SCIMED(R) VENTURE(TM) INFUSION CATHETER
K931335 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 498d
Cleared Jul 27, 1994
DIAGNOSTIC II CATHETER
K940168 · DRF
Ep Technologies, Inc.
Cardiovascular · 201d
Cleared Jul 27, 1994
DISPOSABLE SURGICAL CABLE
K941839 · DSA
Conmed Andover Medical, Inc.
Cardiovascular · 105d
Cleared Jul 27, 1994
MINIMUS II
K942777 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 57d
Cleared Jul 27, 1994
AS/3 PRESSURE TEMPERATURE MODULE, M-PT
K943457 · DSK
Datex Division Instrumentarium Corp.
Cardiovascular · 9d
Cleared Jul 27, 1994
VARIOUS TYPES OF MERCURIALS
K943461 · DXN
Rud Riester GmbH & CO KG
Cardiovascular · 9d
Cleared Jul 26, 1994
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K934292 · DTZ
Minntech Corp.
Cardiovascular · 327d
Cleared Jul 26, 1994
HP M177XA CARDIOGRAPHS
K935772 · LOS
Hewlett-Packard Co.
Cardiovascular · 235d
Cleared Jul 26, 1994
SARNS FILTERED VENOUS RESERVIOR MODIFICATION
K941654 · DTP
3M Health Care, Sarns
Cardiovascular · 112d
Cleared Jul 26, 1994
NCE REPLACEMENT BATTERIES
K941995 · LDD
National Custom Ent., Inc.
Cardiovascular · 92d
Cleared Jul 25, 1994
PEDIATRIC DEFIB K-PADS
K935083 · LDD
Katecho, Inc.
Cardiovascular · 273d
Cleared Jul 25, 1994
ARTERIAL EMBOLECTOMY
K935405 · DXE
J-Lloyd Medical, Inc.
Cardiovascular · 258d
Cleared Jul 20, 1994
HYDROTORQUE GUIDE WIRE
K935232 · DQX
Kingston Technologies, Inc.
Cardiovascular · 261d
Cleared Jul 20, 1994
CMS-90 BLOOD PRESSURE MEASUREMENT ASSISTANT
K936313 · DXQ
Prevention Sciences
Cardiovascular · 285d
Cleared Jul 20, 1994
BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
K941921 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 91d
Not Cleared Jul 20, 1994
AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
K941981 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 97d
Cleared Jul 20, 1994
CONMED ANDOVER MED ECG ELECTRODES
K942925 · DRX
Conmed Andover Medical, Inc.
Cardiovascular · 28d
Cleared Jul 19, 1994
VITALMAX 4000
K933624 · MHX
Pace Tech, Inc.
Cardiovascular · 365d
Cleared Jul 18, 1994
TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)
K936282 · DQO
Cordis Neurovascular, Inc.
Cardiovascular · 200d
Cleared Jul 18, 1994
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
K942066 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d