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
12385–12408 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 20, 1990
MAGNUM-20 (TM) INFLATION DEVICE
K903621 · MAV
Vascumed Systems
Cardiovascular · 134d
Cleared Dec 20, 1990
CARDIOMATIC MODEL MSC-2001
K904353 · DRT
Medical Systems Corp.
Cardiovascular · 87d
Cleared Dec 20, 1990
VACUUM BAKE CYCLE
K904892 · DXY
Medtronic Vascular
Cardiovascular · 51d
Cleared Dec 20, 1990
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
K905101 · DXQ
Hewlett-Packard Co.
Cardiovascular · 37d
Cleared Dec 20, 1990
LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED
K905510 · LDD
Physio-Control Corp.
Cardiovascular · 13d
Cleared Dec 18, 1990
LOCAL REPORT GENERATOR
K904318 · DXN
Spacelabs, Inc.
Cardiovascular · 89d
Cleared Dec 17, 1990
WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER
K892671 · DQO
Wilson Biomedical, Inc.
Cardiovascular · 615d
Cleared Dec 17, 1990
CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS
K900814 · DQK
Intellimetrics Instrument Corp.
Cardiovascular · 299d
Cleared Dec 17, 1990
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K902404 · KFM
3M Company
Cardiovascular · 201d
Cleared Dec 17, 1990
COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
K902437 · DTP
Cobe Laboratories, Inc.
Cardiovascular · 196d
Cleared Dec 17, 1990
COBE ICU CONVERSION KIT
K902631 · DTN
Cobe Laboratories, Inc.
Cardiovascular · 186d
Cleared Dec 17, 1990
HOLLOW LUMEN NEEDLE, PART NUMBER: MX920
K903199 · DQO
Medex, Inc.
Cardiovascular · 150d
Cleared Dec 17, 1990
MONITRODE
K903491 · DRX
Lleventon
Cardiovascular · 136d
Cleared Dec 17, 1990
INTERSEPT 1375 VENOUS RESERVOIR
K903632 · DTN
Medtronic Vascular
Cardiovascular · 129d
Cleared Dec 17, 1990
ADVANCE DISPOSABLE PRESSURE TRANSDUCER
K904601 · DRS
Advance Medical Designs, Inc.
Cardiovascular · 68d
Cleared Dec 17, 1990
CRI STEERABLE CATHETER CONTROL SYSTEM
K904787 · DXX
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 55d
Cleared Dec 17, 1990
MEWISSEN CATHETER
K904788 · DQO
Boston Scientific Corp
Cardiovascular · 55d
Cleared Dec 17, 1990
TRANSLUMINAL ENDARTERECTOMY DEVICE
K904944 · DWX
Baxter Healthcare Corp
Cardiovascular · 46d
Cleared Dec 17, 1990
PSG HEMOSTATIC CONTROL VALVE
K904959 · DQO
Peripheral Systems Group
Cardiovascular · 42d
Cleared Dec 13, 1990
ANGEFLATOR(TM)
K902377 · DXT
Angeion Corp.
Cardiovascular · 197d
Cleared Dec 13, 1990
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
K902723 · DTM
Electromedics, Inc.
Cardiovascular · 177d
Cleared Dec 13, 1990
CARDIOFAX ECG-8830A
K904758 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 55d
Cleared Dec 10, 1990
VESSEL DILATOR
K904476 · DRE
Datascope Corp.
Cardiovascular · 70d
Cleared Dec 06, 1990
GORE-TEX(R) STRETCH VASCULAR GRAFT
K903931 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 104d