FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
14017–14040 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 10, 1987
THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE
K871748 · DRX
The Buddy Systems, Inc.
Cardiovascular · 36d
Cleared Jun 10, 1987
MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
K871915 · DTE
Pace Medical
Cardiovascular · 23d
Cleared Jun 08, 1987
BUBBLE TRAP CAT. NO. B-180
K870819 · DWF
American Omni Medical, Inc.
Cardiovascular · 97d
Cleared Jun 08, 1987
BOWEN REUSEABLE/DISPOSABLE ELECTRODE
K871325 · DRX
Bowen & Company, Inc.
Cardiovascular · 66d
Cleared Jun 08, 1987
PREBYPASS FILTER
K871350 · KRJ
American Omni Medical, Inc.
Cardiovascular · 63d
Cleared Jun 08, 1987
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
K871569 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 45d
Cleared Jun 05, 1987
DORROS(TM) SMALL VESSEL PTA CATHETER
K870460 · DXN
C.R. Bard, Inc.
Cardiovascular · 122d
Cleared Jun 05, 1987
CONSULTANT BODY COMPOSITION ANALYZER
K871040 · DSB
Body Composition Analog, Inc.
Cardiovascular · 80d
Cleared Jun 05, 1987
DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER
K871149 · DRT
Iontec Corp.
Cardiovascular · 74d
Cleared Jun 05, 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · DYB
Pacesetter Systems
Cardiovascular · 72d
Cleared Jun 05, 1987
CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
K871221 · DRY
Cardiovascular Devices, Inc.
Cardiovascular · 70d
Cleared Jun 05, 1987
ACUSON PHYSIOLOGICAL CONTROL MODULE
K871239 · DPS
Acuson Computed Sonography
Cardiovascular · 70d
Cleared Jun 05, 1987
MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
K871363 · DXN
Quinton, Inc.
Cardiovascular · 59d
Cleared Jun 05, 1987
HYPERTENSION RISK DETECTOR(TM)
K871482 · DXN
Pearce Clinical Laboratories, Inc.
Cardiovascular · 52d
Cleared Jun 05, 1987
ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200
K871626 · DRX
Jason Marketing Co.
Cardiovascular · 39d
Cleared Jun 05, 1987
MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER
K871719 · DXN
A&D Engineering, Inc.
Cardiovascular · 32d
Cleared Jun 05, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871861 · DXY
Telectronics, Inc.
Cardiovascular · 23d
Cleared Jun 02, 1987
POET OXIMETER
K864745 · DQE
Criticare Systems, Inc.
Cardiovascular · 179d
Cleared Jun 02, 1987
CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA.
K870411 · DQY
Medical Surgical Concepts, Inc.
Cardiovascular · 119d
Cleared Jun 01, 1987
PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)
K870413 · DRE
Medical Surgical Concepts, Inc.
Cardiovascular · 118d
Cleared May 28, 1987
ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)
K870016 · DTB
Migada, Ltd.
Cardiovascular · 146d
Cleared May 28, 1987
OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C
K871207 · DXN
Omron Electronics, Inc.
Cardiovascular · 64d
Cleared May 28, 1987
IMS-2000S STRESS MONITOR
K871659 · DXG
Integrated Medical Systems, Inc.
Cardiovascular · 30d
Cleared May 27, 1987
CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D
K863969 · DXO
Camino Laboratories, Inc.
Cardiovascular · 225d