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
9169–9192 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 19, 2000
PROAIR 3000 COMPRESSION SYSTEM
K993758 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 196d
Cleared May 18, 2000
APEXPRO TELEMETRY SYSTEM
K000779 · DSI
General Electric Medical Systems...
Cardiovascular · 69d
Cleared May 18, 2000
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP),...
K001237 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 30d
Cleared May 18, 2000
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K992320 · LIT
Boston Scientific Corp
Cardiovascular · 311d
Cleared May 18, 2000
HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD,...
K992543 · MKJ
Hewlett-Packard Co.
Cardiovascular · 293d
Cleared May 17, 2000
MODIFICATION TO ENVOY PATIENT MONITOR
K000563 · MHX
Mennen Medical , Ltd.
Cardiovascular · 85d
Cleared May 17, 2000
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
K000690 · DRX
Minnesota Mining and Mfg. Co.
Cardiovascular · 78d
Cleared May 17, 2000
HEART 2005
K000775 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 69d
Cleared May 17, 2000
AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND...
K001333 · DSI
Agilent Technologies Deutschland GmbH
Cardiovascular · 20d
Cleared May 17, 2000
ST/AR ST AND ARRHYTHMIA SOFTWARE
K001348 · MHX
Agilent Technologies, Inc.
Cardiovascular · 19d
Cleared May 16, 2000
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS...
K000303 · JOW
Healthcare Service and Supply
Cardiovascular · 105d
Cleared May 15, 2000
ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
K994334 · DYB
Daig Corp.
Cardiovascular · 144d
Cleared May 12, 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER...
K001198 · DQX
Datascope Corp.
Cardiovascular · 29d
Cleared May 11, 2000
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE...
K991886 · KRB
Pulsion Medical Systems, Inc.
Cardiovascular · 344d
Cleared May 10, 2000
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
K001139 · DYB
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared May 05, 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K000190 · DQK
Biosense Webster, Inc.
Cardiovascular · 113d
Cleared May 05, 2000
CARTO EP NAVIGATION SYSTEM
K000248 · DQK
Biosense Webster, Inc.
Cardiovascular · 99d
Cleared May 05, 2000
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE...
K001100 · DSB
Cardiodynamics International Corp.
Cardiovascular · 30d
Cleared May 05, 2000
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215...
K991293 · JOQ
Fischer Medical Technologies, Inc.
Cardiovascular · 386d
Cleared May 05, 2000
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT...
K994243 · DWF
Heartport, Inc.
Cardiovascular · 141d
Cleared May 04, 2000
NOGA CARDIAC NAVIGATION SYSTEM
K000332 · DQK
Biosense Webster, Inc.
Cardiovascular · 91d
Cleared May 04, 2000
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
K992592 · KFM
A-Med Systems, Inc.
Cardiovascular · 276d
Cleared May 04, 2000
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD...
K993816 · MCW
Baxter Edwards
Cardiovascular · 176d
Cleared May 03, 2000
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579 · DQO
Cordis Corp.
Cardiovascular · 71d