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
11953–11976 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 19, 1991
ES1600 PARAMEDIC TELEPHONE
K912281 · DXH
Epic Systems, Inc.
Cardiovascular · 180d
Cleared Nov 19, 1991
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
K913805 · DTE
Pace Medical
Cardiovascular · 85d
Cleared Nov 15, 1991
MERIT CUSTOM KIT
K913682 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 88d
Cleared Nov 15, 1991
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
K913692 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 88d
Cleared Nov 08, 1991
THE BIG EASY Y-ADAPTER
K914046 · DYB
Microvena Corp.
Cardiovascular · 59d
Cleared Nov 07, 1991
CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS
K911871 · DXN
Cardiodyne, Inc.
Cardiovascular · 195d
Cleared Nov 07, 1991
DELPHIN II CENTRIFUGAL SYSTEM
K913176 · KFM
3M Health Care, Sarns
Cardiovascular · 113d
Cleared Nov 07, 1991
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)
K913533 · DXH
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Nov 07, 1991
STETHOSCOPE
K914100 · LDE
Atlas Medical Products, Inc.
Cardiovascular · 56d
Cleared Nov 07, 1991
VASCUMAP MEDICAL AIR PLETHYSMOGRAPH
K914200 · DSB
Carolina Medical Electronics
Cardiovascular · 49d
Cleared Nov 06, 1991
AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
K913523 · DXN
Omron Healthcare, Inc.
Cardiovascular · 90d
Cleared Nov 05, 1991
Q4500 STREE TEST MONITOR
K910017 · DPS
Quinton, Inc.
Cardiovascular · 306d
Not Cleared Nov 05, 1991
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
K910997 · DSP
Datascope Corp.
Cardiovascular · 242d
Cleared Nov 05, 1991
ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION
K912477 · DQO
Interventional Therapeutics Corp.
Cardiovascular · 154d
Cleared Nov 05, 1991
TORQUE FITTING
K912969 · DTL
Freedom Machine, Inc.
Cardiovascular · 120d
Cleared Nov 05, 1991
0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE
K913074 · DQX
Terumo Medical Corp.
Cardiovascular · 117d
Cleared Nov 05, 1991
TEGWIRE (TM)
K913391 · LIT
Boston Scientific Corp
Cardiovascular · 98d
Cleared Nov 05, 1991
ISOLATE INFUSION CATHETR SYSTEM
K913517 · DQY
Lake Region Mfg., Inc.
Cardiovascular · 90d
Cleared Nov 05, 1991
GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
K914447 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Nov 05, 1991
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
K914448 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Nov 05, 1991
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE
K914450 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Nov 05, 1991
COORDINATOR, CABLE INPUT
K914725 · DPS
Cardiotronics, Inc.
Cardiovascular · 15d
Cleared Oct 31, 1991
TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
K912045 · DXS
Lifestream Int'L, Inc.
Cardiovascular · 176d
Cleared Oct 31, 1991
MEGA ANGIOGRAM KIT
K913397 · DQO
Mega Medical, Inc.
Cardiovascular · 93d