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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
14089–14112 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 03, 1987
MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER
K862383 · DSB
Rjl Systems, Inc.
Cardiovascular · 224d
Cleared Feb 03, 1987
CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
K863100 · DPS
Honeywell, Inc.
Cardiovascular · 174d
Cleared Feb 03, 1987
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
K864619 · KRL
Shiley, Inc.
Cardiovascular · 71d
Cleared Feb 02, 1987
EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND
K862859 · DXK
Biosound, Inc.
Cardiovascular · 188d
Cleared Feb 02, 1987
ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM
K864657 · DXK
Advanced Technology Laboratories, Inc.
Cardiovascular · 66d
Cleared Jan 16, 1987
40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON
K863185 · DSP
Aries Medical, Inc.
Cardiovascular · 150d
Cleared Jan 16, 1987
FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
K864000 · DXO
Fiberoptic Sensor Technlogies, Inc.
Cardiovascular · 94d
Cleared Jan 16, 1987
MODEL 366-13 ADAPTAID STEP DOWN ADAPTER
K864326 · DTB
Intermedics, Inc.
Cardiovascular · 73d
Cleared Jan 14, 1987
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
K863042 · DSK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 155d
Cleared Jan 14, 1987
SYSTEM 90 TRANSPORT
K863219 · DSP
Datascope Corp.
Cardiovascular · 147d
Cleared Jan 14, 1987
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868 · DRX
Hewlett-Packard Co.
Cardiovascular · 33d
Cleared Jan 12, 1987
EDP-20 PACEMAKER
K860036 · DXY
Biotronik Sales, Inc.
Cardiovascular · 371d
Cleared Jan 12, 1987
MINGOGRAF 410
K864009 · DPS
Siemens Medical Solutions USA, Inc.
Cardiovascular · 89d
Cleared Jan 12, 1987
SCANLAN (TM) VEIN/GRAFT HOLDER
K864919 · KPK
Scanlan Intl., Inc.
Cardiovascular · 27d
Cleared Jan 06, 1987
ANGIOTOPO CATHETER
K861241 · DQO
Houston Biomedical, Inc.
Cardiovascular · 279d
Cleared Jan 06, 1987
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
K862051 · DTB
Intermedics, Inc.
Cardiovascular · 222d
Cleared Jan 06, 1987
MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH
K863153 · DXG
Ocg Technology, Inc.
Cardiovascular · 144d
Cleared Jan 06, 1987
MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES
K863369 · DRX
Tdk Corp.
Cardiovascular · 166d
Cleared Jan 06, 1987
LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.
K863535 · DPS
Computerized Medical Systems, Inc.
Cardiovascular · 117d
Cleared Jan 06, 1987
MEDTRONIC MODEL 5013
K863536 · DTB
Medtronic Vascular
Cardiovascular · 117d
Cleared Jan 06, 1987
URESIL SUBCLAVIAN CATHETER
K863684 · DQY
Uresil Corp.
Cardiovascular · 109d
Cleared Jan 06, 1987
DISPOSABLE ECG MONITORING ELECTRODE
K863904 · DRX
Clinical Data, Inc.
Cardiovascular · 91d
Cleared Jan 06, 1987
MODIFICATION TO DYNASCOPE SERIES MONITORS
K863914 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 90d
Cleared Jan 06, 1987
CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM
K863916 · DQY
Cardio-Vascular Innovations, Inc.
Cardiovascular · 90d