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
16897–16920 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 23, 1980
TRANSVENOUS PACEMAKER ELECTRODE KIT
K802259 · LDF
Stanco Medical, Inc.
Cardiovascular · 37d
Cleared Oct 23, 1980
CRITERION II PACING SYSTEM MONITORS
K802325 · DRT
Dart Medical Equipment
Cardiovascular · 30d
Cleared Oct 10, 1980
GORE-TEX VASCULAR GRAFT
K802095 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 38d
Cleared Oct 10, 1980
VASCULAR CATHETER WIREGUIDES
K802260 · DQX
Stanco Medical, Inc.
Cardiovascular · 24d
Cleared Oct 10, 1980
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON
K802282 · DRR
Consolidated Medical Equipment, Inc.
Cardiovascular · 21d
Cleared Oct 10, 1980
MLC-4200 CARDIAC OUTPUT COMPUTER
K802305 · DXG
Nihon Kohden America, Inc.
Cardiovascular · 17d
Cleared Oct 10, 1980
PRESSURE MONITORING LINES
K802326 · DRI
Stanco Medical, Inc.
Cardiovascular · 17d
Cleared Oct 10, 1980
SHEATH DILATOR SET
K802327 · DRE
Stanco Medical, Inc.
Cardiovascular · 17d
Cleared Oct 10, 1980
DISP. TOUGY-BORST TYPE ADAPTOR W/PORT
K802328 · DTZ
Stanco Medical, Inc.
Cardiovascular · 17d
Cleared Oct 10, 1980
TORQUE CONTROL BALLOON CATHETER
K802338 · DYG
Cordis Corp.
Cardiovascular · 14d
Cleared Oct 10, 1980
QUICK PRIME LINES, #'S BPL-12, BPL-48 &
K802378 · DWF
Bentley Laboratories, Inc.
Cardiovascular · 10d
Cleared Oct 03, 1980
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 78d
Cleared Oct 03, 1980
U.I. OCTOSON
K802030 · DXK
Ausonics Pty , Ltd.
Cardiovascular · 43d
Cleared Oct 03, 1980
CM-700A AUTO-INFLATE CONTROL MODULE
K802203 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 22d
Cleared Oct 03, 1980
CT-1600 DIGITAL PULSE RATE MONITOR
K802204 · DRT
Industrial & Biomedical Sensors Corp.
Cardiovascular · 22d
Cleared Oct 03, 1980
CORROSION PROOF SNAP ECG CONNECT WIRES
K802236 · DSA
Custom Cardio Components
Cardiovascular · 18d
Cleared Oct 03, 1980
CORROSION PROOF DUAL PURPOSE ECG WIRES
K802237 · DSA
Custom Cardio Components
Cardiovascular · 18d
Cleared Oct 03, 1980
VESSEL RETRACTOR, #600732
K802244 · DXC
Bentley Laboratories, Inc.
Cardiovascular · 17d
Cleared Oct 03, 1980
PRESSURE GAUGE ACCESSORY KIT/DILATATION
K802261 · DWF
Stanco Medical, Inc.
Cardiovascular · 17d
Cleared Oct 03, 1980
TELEMETRY TRANSMITTER, #TLT-3
K802273 · DRG
Bd Becton Dickinson Vacutainer...
Cardiovascular · 16d
Cleared Sep 26, 1980
BIFOCAL 2 8200 SERIES (A,B C,D)
K800379 · DXY
American Pacemaker Corp.
Cardiovascular · 217d
Cleared Sep 26, 1980
HEARTWATCH
K800519 · DRT
D. Jenkins
Cardiovascular · 204d
Cleared Sep 26, 1980
MEDTRONIC MODEL 69575
K800944 · DTB
Medtronic Vascular
Cardiovascular · 157d
Cleared Sep 26, 1980
HALL ARTERIAL OSCILLATOR
K801063 · DWX
American Sterilizer Co.
Cardiovascular · 143d