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
12985–13008 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 12, 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · DQY
C.R. Bard, Inc.
Cardiovascular · 49d
Cleared Sep 08, 1989
EPLAB (ELECTROCARDIOGRAPHIC MONITOR)
K893836 · DSH
Quinton Electrophysiology Corp.
Cardiovascular · 107d
Cleared Sep 06, 1989
MODIFIED LABELING TO PERMANENT LEAD INTRODUCER
K894431 · DYB
Daig Corp.
Cardiovascular · 51d
Cleared Sep 05, 1989
STEALTH DILATION CATHETER SYSTEM
K893411 · LIT
Target Therapeutics
Cardiovascular · 126d
Cleared Sep 05, 1989
BARD CATH LAB THERMODILUTION CATHETER
K893474 · DYG
C.R. Bard, Inc.
Cardiovascular · 124d
Cleared Sep 05, 1989
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER
K893963 · DSB
V.S.B.B. Technologies, Inc.
Cardiovascular · 95d
Cleared Sep 05, 1989
ARBO H79P DISPOSABLE MONITORING ELECTRODES
K894562 · DRX
Arbo Medical, Inc.
Cardiovascular · 46d
Cleared Sep 05, 1989
ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO
K894648 · DRX
Arbo Medical, Inc.
Cardiovascular · 43d
Cleared Sep 05, 1989
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
K894718 · DTD
Intermedics, Inc.
Cardiovascular · 42d
Cleared Aug 28, 1989
DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM
K892370 · DXH
Bio-Focus, Inc.
Cardiovascular · 144d
Cleared Aug 25, 1989
HOME BLOOD PRESSURE KIT, ANEROID
K884420 · DXY
Yamasu Co. , Ltd.
Cardiovascular · 309d
Cleared Aug 25, 1989
MODEL 5650 OPTIMATE PERSONAL PROGRAMMER
K884522 · KRG
Teletronics, Inc.
Cardiovascular · 302d
Cleared Aug 25, 1989
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
K890988 · LDF
Pace Medical
Cardiovascular · 179d
Cleared Aug 25, 1989
PULSE TIME PRODUCTS LIMITED, PM-2
K892794 · DRT
Pulse Time Products, Ltd.
Cardiovascular · 130d
Cleared Aug 25, 1989
PULSE TIME PRODUCTS LIMITED, PM-3
K892795 · DRT
Pulse Time Products, Ltd.
Cardiovascular · 130d
Cleared Aug 25, 1989
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.
K893561 · DSF
Edentec Corp.
Cardiovascular · 108d
Cleared Aug 25, 1989
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
K894055 · DXY
Medtronic Vascular
Cardiovascular · 79d
Cleared Aug 24, 1989
ELECTRONIC BLOOD PRESSURE MONITORS
K894062 · DXN
Hanson Scale Co.
Cardiovascular · 77d
Cleared Aug 17, 1989
USCI PROBING CATHETER
K890152 · DQY
C.R. Bard, Inc.
Cardiovascular · 216d
Cleared Aug 17, 1989
USCI PROBE LINX EXTENSION WIRE
K890404 · DQX
C.R. Bard, Inc.
Cardiovascular · 205d
Cleared Aug 17, 1989
USCI PTA BALLOON DILATATION CATHETER
K890405 · LIT
C.R. Bard, Inc.
Cardiovascular · 205d
Cleared Aug 17, 1989
TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE
K894084 · DQY
Target Therapeutics
Cardiovascular · 70d
Cleared Aug 17, 1989
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
K894185 · DXY
Telectronics Pacing Systems, Inc.
Cardiovascular · 62d
Cleared Aug 17, 1989
C.A.B. RING
K894268 · MAB
Medi-Sharp, Inc.
Cardiovascular · 56d