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
12529–12552 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 23, 1990
BP50 BLOOD PRESSURE AND PULSE MONITOR
K901392 · DXN
Pulse Time Products, Ltd.
Cardiovascular · 150d
Cleared Aug 23, 1990
FUKUDA DENSHI MODEL FX-3101
K901817 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 122d
Cleared Aug 23, 1990
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
K902355 · DTP
Medtronic Vascular
Cardiovascular · 86d
Cleared Aug 23, 1990
OSCILLOMETRIC PULSE DETECTION DEVICE
K902453 · DRS
Thomas J. Fogarty, M.D.
Cardiovascular · 83d
Cleared Aug 23, 1990
BYRD DILATOR SHEATH SET - TEFLON
K902469 · DRE
Medical Engineering and Development...
Cardiovascular · 80d
Cleared Aug 23, 1990
MORSE DT MANIFOLD
K902472 · DRS
North American Instrument Corp.
Cardiovascular · 80d
Cleared Aug 23, 1990
CARDIOVISTA
K902486 · DSH
Cardionostics, Inc.
Cardiovascular · 80d
Cleared Aug 23, 1990
MORTARA INSTRUMENT MODEL ELI 50
K902652 · DRT
Mortara Instrument, Inc.
Cardiovascular · 69d
Cleared Aug 23, 1990
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
K902889 · DTD
Biotronik, GmbH & Co.
Cardiovascular · 52d
Cleared Aug 23, 1990
ARIES TAPERSEAL(TM) SHEATH
K903442 · DYB
Aries Medical, Inc.
Cardiovascular · 23d
Cleared Aug 22, 1990
ULTRA-VU ANGIOSCOPE
K902329 · LYK
Angiolaz, Inc.
Cardiovascular · 90d
Cleared Aug 17, 1990
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
K896497 · DSP
Datascope Corp.
Cardiovascular · 276d
Cleared Aug 15, 1990
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
K900994 · DTL
Dlp, Inc.
Cardiovascular · 166d
Cleared Aug 14, 1990
PERFUSION MONITOR
K900860 · DTY
Cardio Metrics, Inc.
Cardiovascular · 172d
Cleared Aug 14, 1990
INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE
K900998 · DQY
Intec Medical, Inc.
Cardiovascular · 166d
Cleared Aug 14, 1990
BARD EXTRACORPOREAL CIRCULATION CANNULAE
K902277 · DWF
C.R. Bard, Inc.
Cardiovascular · 85d
Cleared Aug 14, 1990
BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION
K903360 · DWJ
Augustine Medical, Inc.
Cardiovascular · 29d
Cleared Aug 10, 1990
ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER
K901335 · DPW
Ge Medical Systems Information...
Cardiovascular · 141d
Cleared Aug 08, 1990
BIOTRONIK'S PS-ENDOCARDIAL LEADS
K896824 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 247d
Cleared Aug 08, 1990
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
K900645 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 180d
Cleared Aug 08, 1990
ITC INTRODUCER CATHETER
K900756 · DYB
Interventional Therapeutics Corp.
Cardiovascular · 173d
Cleared Aug 08, 1990
MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND
K902088 · DPW
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Aug 08, 1990
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE
K902207 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 84d
Cleared Aug 08, 1990
MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE
K902221 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 83d