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
14305–14328 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 06, 1986
NEOGUARD ECG ELECTRODES
K861364 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 117d
Cleared Aug 06, 1986
MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS
K861375 · DXN
Sharp Electronics Corp.
Cardiovascular · 191d
Cleared Aug 06, 1986
GOULD XCALIBER
K862344 · DRS
Bio-Tek Instruments, Inc.
Cardiovascular · 47d
Cleared Aug 06, 1986
KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH
K862544 · DPS
Suzuken Co., Ltd.
Cardiovascular · 34d
Cleared Aug 06, 1986
SIGNA II RESTING ECG ELECTRODE
K862655 · DRX
Kone Instruments, Inc.
Cardiovascular · 23d
Cleared Aug 06, 1986
EM DIAGNOSTIC ECG ELECTRODE
K862746 · DRX
Electromed Intl., Ltd.
Cardiovascular · 16d
Cleared Aug 06, 1986
PREGELLED INFANT DISPOSABLE ECG ELECTRODE
K862756 · DXN
Labeltape Meditect, Inc.
Cardiovascular · 15d
Cleared Aug 06, 1986
EUROMED S-601
K862765 · DRX
Lectec Corp.
Cardiovascular · 15d
Cleared Aug 05, 1986
CORDIS ANCOR ACTIVE FIXATION LEAD
K832422 · DTB
Cordis Corp.
Cardiovascular · 1110d
Cleared Aug 05, 1986
CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR
K851064 · DTB
Cordis Corp.
Cardiovascular · 508d
Cleared Aug 05, 1986
UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO
K861984 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 75d
Cleared Aug 04, 1986
MIKROS, MIKROS VS-1, PULSE GENERATOR
K860922 · DXY
Biotronik Sales, Inc.
Cardiovascular · 146d
Cleared Aug 04, 1986
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
K861368 · JOQ
Medtronic Vascular
Cardiovascular · 115d
Cleared Aug 01, 1986
MICROCOR E.C.G. MONITOR WITH A.C. ADAPTER
K861281 · DPS
Microcor, Inc.
Cardiovascular · 116d
Cleared Jul 30, 1986
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689 · DSK
Spacelabs, Inc.
Cardiovascular · 155d
Cleared Jul 30, 1986
ACUSON L558 TRANSDUCER
K861579 · JOP
Acuson Computed Sonography
Cardiovascular · 93d
Cleared Jul 30, 1986
ACUSON S519 TRANSDUCER
K861596 · JOP
Acuson Computed Sonography
Cardiovascular · 92d
Cleared Jul 30, 1986
PACEMAKER LEAD ADAPTER
K862656 · DTD
Cordis Corp.
Cardiovascular · 16d
Cleared Jul 29, 1986
MILLAR PULSED DOPPLER VELOCIMETER
K860766 · DPW
Millar Instruments, Inc.
Cardiovascular · 148d
Cleared Jul 24, 1986
MERIDIAN IMAGING SYSTEM
K861737 · JOP
Johnson & Johnson Professionals, Inc.
Cardiovascular · 79d
Cleared Jul 24, 1986
ACUSON S319 TRANSDUCER
K862159 · JOP
Acuson Computed Sonography
Cardiovascular · 48d
Cleared Jul 21, 1986
RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT
K861790 · DWF
Research Medical, Inc.
Cardiovascular · 73d
Cleared Jul 18, 1986
THE NAVIGATOR STEERABLE GUIDE WIRE
K860430 · DQX
Meadox Surgimed, Inc.
Cardiovascular · 164d
Cleared Jul 18, 1986
MICRON, MICROVASCULAR DOPPLER
K860651 · DPW
Diagnostic Electronics Corp.
Cardiovascular · 147d