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
14473–14496 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 30, 1986
ETP 180 CARDIAC PACEMAKER (EXTERNAL)
K860551 · DRO
Biotronics Corp.
Cardiovascular · 76d
Cleared Apr 30, 1986
HEARTSTART 2000
K860676 · MKJ
First Medical Devices Corp.
Cardiovascular · 64d
Cleared Apr 29, 1986
BARD PARKER PERFUSION CATHETER
K855201 · DQY
Bd Becton Dickinson Vacutainer...
Cardiovascular · 123d
Cleared Apr 29, 1986
CARDIO-COOL
K860523 · DTR
Bio-Vascular, Inc.
Cardiovascular · 76d
Cleared Apr 29, 1986
SARNS OXYGENATOR SYSTEM
K860539 · DTZ
3M Health Care, Sarns
Cardiovascular · 76d
Cleared Apr 29, 1986
SPACELABS MEDICAL WORKSTATION
K860834 · DSI
Spacelabs, Inc.
Cardiovascular · 55d
Cleared Apr 29, 1986
SUBCLAVIAN INTRODUCER SET
K860898 · DYB
Infusaid Corp.
Cardiovascular · 50d
Cleared Apr 29, 1986
PERCUTANEOUS CATHETERS
K861008 · DQY
Micor, Inc.
Cardiovascular · 42d
Cleared Apr 29, 1986
MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER
K861176 · DTB
Intermedics, Inc.
Cardiovascular · 29d
Cleared Apr 28, 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · DXN
Nihon Kohden America, Inc.
Cardiovascular · 181d
Cleared Apr 28, 1986
PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3
K860287 · DXN
Healthcheck Corp.
Cardiovascular · 90d
Cleared Apr 28, 1986
GUIDE WIRE INTRODUCER
K860841 · DQX
Target Therapeutics
Cardiovascular · 55d
Cleared Apr 23, 1986
5000 SERIES ECG ELECTRODES
K854757 · DRX
Alternative Design Systems, Inc.
Cardiovascular · 147d
Cleared Apr 23, 1986
MODIFIED CHERNE CAD DETECTOR
K860015 · DXG
Cherne Industries, Inc.
Cardiovascular · 110d
Cleared Apr 23, 1986
MEADOX SURGIMED GUIDE CATHETER
K860429 · DQO
Meadox Surgimed, Inc.
Cardiovascular · 78d
Cleared Apr 23, 1986
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
K860546 · KRG
Pacesetter Systems
Cardiovascular · 69d
Cleared Apr 23, 1986
MODEL E 600 ELECTROCARDIOGRAPH
K860767 · DSI
Kone Instruments, Inc.
Cardiovascular · 51d
Cleared Apr 23, 1986
GUIDED WIRE TORQUER
K860840 · DQX
Target Therapeutics
Cardiovascular · 50d
Cleared Apr 23, 1986
ANGIOJECT
K860842 · DXT
Target Therapeutics
Cardiovascular · 50d
Cleared Apr 23, 1986
CATHETER INTRODUCER
K860958 · DYB
Target Therapeutics
Cardiovascular · 41d
Cleared Apr 23, 1986
BIPOLAR CARDIAC PACEMAKER, MODEL 110
K861009 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 36d
Cleared Apr 23, 1986
MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER
K861110 · DTB
Intermedics, Inc.
Cardiovascular · 29d
Cleared Apr 17, 1986
EM ELECTRODE
K853774 · DRX
Electromed Intl., Ltd.
Cardiovascular · 219d
Cleared Apr 17, 1986
OMRON DIGITAL BP MONITOR HEM-700CP
K854201 · DXN
Omron Tateisi Electronics Co.
Cardiovascular · 184d