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
12553–12576 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 31, 1990
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
K896807 · DTR
Gish Biomedical, Inc.
Cardiovascular · 239d
Cleared Jul 31, 1990
ZAP-GUARD
K896985 · DRL
Guardian Angel Products, Inc.
Cardiovascular · 230d
Cleared Jul 31, 1990
EPICARDIA 4000
K900207 · DST
Medicomp, Inc.
Cardiovascular · 196d
Cleared Jul 31, 1990
APPLICARD (EKG)
K900459 · DRY
Medi-Globe Corp.
Cardiovascular · 182d
Cleared Jul 31, 1990
PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE
K900682 · DRY
Contour Electrodes, Inc.
Cardiovascular · 168d
Cleared Jul 31, 1990
TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
K901247 · DYG
Intec Medical, Inc.
Cardiovascular · 138d
Cleared Jul 31, 1990
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS
K901252 · DXQ
Hewlett-Packard Co.
Cardiovascular · 137d
Cleared Jul 31, 1990
MOVABLE CORE GUIDEWIRE
K902152 · DQX
Guidewire Technologies, Inc.
Cardiovascular · 77d
Cleared Jul 31, 1990
TEFLON COATED GUIDEWIRE
K902153 · DQX
Guidewire Technologies, Inc.
Cardiovascular · 76d
Cleared Jul 31, 1990
SUBCLAVIAN INTRODUCER SET
K902251 · DYB
Infusaid Corp.
Cardiovascular · 76d
Cleared Jul 31, 1990
NF-50-E DISPOSABLE ECG ELECTRODE
K902407 · DRX
Medicotest, Inc.
Cardiovascular · 61d
Cleared Jul 27, 1990
ESCORT MODEL 400T TELEMETRY ECG MONITOR
K902254 · DXH
Medical Data Electronics
Cardiovascular · 67d
Cleared Jul 26, 1990
EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER
K902042 · DSB
Em-Scan, Inc.
Cardiovascular · 83d
Cleared Jul 19, 1990
ISOFLO(TM) HIGH PRESSURE INJECTION LINES
K901382 · DXT
Healthdyne Cardiovascular, Inc.
Cardiovascular · 119d
Cleared Jul 19, 1990
MODELS 4201, 4231 & 4235 EXTENSION CABLES
K902679 · DTE
Pace Medical
Cardiovascular · 30d
Cleared Jul 18, 1990
CWD/PPG MODULE
K896500 · JOM
Life Sciences Manufacturing, Inc.
Cardiovascular · 246d
Cleared Jul 18, 1990
PAG MICROPROCESSOR-CONTROLLED MODULE
K900365 · DQC
Life Sciences Manufacturing, Inc.
Cardiovascular · 174d
Cleared Jul 18, 1990
VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE
K900451 · DRT
Pace Tech, Inc.
Cardiovascular · 169d
Cleared Jul 18, 1990
DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES
K900664 · DRC
Sterimed, Inc.
Cardiovascular · 155d
Cleared Jul 18, 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · DRX
Medtronic Vascular
Cardiovascular · 106d
Cleared Jul 18, 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · DRX
3M Company
Cardiovascular · 71d
Cleared Jul 18, 1990
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590 · LDD
Marquette Electronics, Inc.
Cardiovascular · 36d
Cleared Jul 17, 1990
PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A
K895520 · LOS
Hewlett-Packard Co.
Cardiovascular · 308d
Cleared Jul 17, 1990
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742 · DTB
Ela Medical, Inc.
Cardiovascular · 229d