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
9361–9384 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 19, 1999
ALARMVIEW SYSTEM
K992848 · MSX
Data Critical Corp.
Cardiovascular · 87d
Cleared Nov 19, 1999
IBC VENT VALVE, MODEL 1400
K992964 · MNJ
International Biophysics Corp.
Cardiovascular · 78d
Cleared Nov 18, 1999
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
K991786 · DPS
General Electric Medical Systems...
Cardiovascular · 177d
Cleared Nov 16, 1999
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018...
K991059 · DQY
Spectranetics Corp.
Cardiovascular · 231d
Cleared Nov 16, 1999
UNI-GRAFT K DV PATCH
K992776 · DXZ
Atrium Medical Corp.
Cardiovascular · 90d
Cleared Nov 12, 1999
CONSTELLATION CATHETERS, MODEL 8039
K992777 · MTD
Boston Scientific Corp
Cardiovascular · 86d
Cleared Nov 12, 1999
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863 · DRB
Guidant Corp.
Cardiovascular · 79d
Cleared Nov 12, 1999
IMPRESARIO
K993620 · DQK
Del Mar Medical Systems, LLC
Cardiovascular · 17d
Cleared Nov 10, 1999
VACUUM ASSIST STABILIZER
K992833 · MWS
Cardio Thoracic Systems
Cardiovascular · 79d
Cleared Nov 10, 1999
LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
K992857 · DTW
Rocky Mountain Research, Inc.
Cardiovascular · 77d
Cleared Nov 10, 1999
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
K992906 · DTL
Olson Medical Sales, Inc.
Cardiovascular · 72d
Cleared Nov 10, 1999
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
K993434 · DXY
Biotronik, Inc.
Cardiovascular · 29d
Cleared Nov 08, 1999
HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
K992674 · MHX
Hewlett-Packard GmbH
Cardiovascular · 90d
Cleared Nov 08, 1999
HP M2600A VIRIDIA TELEMETRY SYSTEM
K993516 · DSI
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Nov 05, 1999
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL...
K990103 · DTZ
Sorin Biomedical, Inc.
Cardiovascular · 297d
Cleared Nov 05, 1999
ULTRA-CBX
K991486 · DWZ
Medcanica, Inc.
Cardiovascular · 191d
Cleared Nov 05, 1999
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · DRF
C.R. Bard, Inc.
Cardiovascular · 113d
Cleared Nov 03, 1999
MUSE CARDIOVASCULAR INFORMATION SYSTEM
K992637 · DSI
General Electric Medical Systems...
Cardiovascular · 89d
Cleared Nov 02, 1999
BARD HYDROPHILIC COATED GUIDE WIRES
K993000 · DQX
C.R. Bard, Inc.
Cardiovascular · 56d
Cleared Nov 01, 1999
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
K992323 · MLD
Datex-Ohmeda, Inc.
Cardiovascular · 112d
Cleared Nov 01, 1999
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K992599 · DTN
Dideco S.P.A.
Cardiovascular · 90d
Cleared Oct 28, 1999
DUAL LUMEN CATHETER, MODEL DL-35-90
K991601 · DQY
Endologix, Inc.
Cardiovascular · 171d
Cleared Oct 28, 1999
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
K992169 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 122d
Cleared Oct 28, 1999
CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS...
K993245 · DYG
Alba Critical Care, Ltd.
Cardiovascular · 30d