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
16129–16152 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 28, 1982
MARK V
K822536 · DXT
Medrad, Inc.
Cardiovascular · 35d
Cleared Sep 28, 1982
PERCUTANEOUS CATHETER INTRODUCER SET
K822593 · DYB
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
POLYETHYLENE CARDIOVASCULAR CATHETER
K822594 · DQO
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
VESSEL DILATOR
K822595 · DRE
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS
K822598 · DQO
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
CORONARY INFUSION KIT
K822640 · DQO
Mallinckrodt Critical Care
Cardiovascular · 27d
Cleared Sep 28, 1982
ERIE OXYGEN CONCENTRATOR
K822719
Erie Controls
Cardiovascular · 21d
Cleared Sep 24, 1982
VASOGRAPH, MODEL MV-2
K822455 · DSB
Electro-Diagnostic Instruments
Cardiovascular · 39d
Cleared Sep 21, 1982
STAT-SCAN
K822093 · DXG
Survival Technology, Inc.
Cardiovascular · 67d
Cleared Sep 21, 1982
HEART MONITOR BRACELET ALARM
K822316 · DRI
Hmba
Cardiovascular · 49d
Cleared Sep 21, 1982
LIFE TRACE 40/42
K822389 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 43d
Cleared Sep 21, 1982
LIFE TRACE 24
K822390 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 43d
Cleared Sep 21, 1982
BIOMEGA MODEL 59W
K822438 · DXN
Bio Mega Diagnostic, Inc.
Cardiovascular · 39d
Cleared Sep 21, 1982
QUIKPAGE SCANNER
K822582 · DPS
Agilent Technologies
Cardiovascular · 27d
Cleared Sep 21, 1982
VERTEX PERCUTANEOUS PUNCTURE NEEDLE
K822596 · DQO
Vertex Medical Corp.
Cardiovascular · 25d
Cleared Sep 21, 1982
GUIDE WIRE
K822597 · DQX
Vertex Medical Corp.
Cardiovascular · 25d
Cleared Sep 21, 1982
BLOOD PRESSURE MONITORING DEVICES
K822614 · DXN
Allied Healthcare Products, Inc.
Cardiovascular · 22d
Cleared Sep 21, 1982
LIFE WATCH LSI
K822615 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 22d
Cleared Sep 14, 1982
RE1000 HEART RATE MONITOR
K822319 · DRT
Electronic Monitors, Inc.
Cardiovascular · 42d
Cleared Sep 14, 1982
DISPOSABLE TRANSDUCER & ACCESSORIES
K822507 · DRS
Gould, Inc.
Cardiovascular · 26d
Cleared Sep 14, 1982
SINGLE CHANNEL NONFADE OSCILLOSCOPE
K822517 · DXJ
Quinton, Inc.
Cardiovascular · 25d
Cleared Aug 31, 1982
GUIDE WIRE
K821190 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 126d
Cleared Aug 31, 1982
BARD PTFE VASCULAR PROSTHESIS
K821716 · DSY
C.R. Bard, Inc.
Cardiovascular · 82d
Cleared Aug 31, 1982
FRANKLIN QUANTIC 1200
K822236 · DXK
Bruce Franklin, Inc.
Cardiovascular · 34d