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
16513–16536 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 02, 1981
URE SIL EMBOLECTOMY/THROMBECTOMY CATH
K812640 · DXE
Uresil Corp.
Cardiovascular · 16d
Cleared Sep 25, 1981
CENTERAL MONITOR 360
K812144 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-3
K812145 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-5
K812146 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-7
K812147 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
DISPOSABLE ELECTRODE, #1610
K812276 · DRX
Andover Medical, Inc.
Cardiovascular · 43d
Cleared Sep 25, 1981
FLOW-DIRECTED THERMODILUTION CATHETER
K812324 · DYG
Sorensen Research
Cardiovascular · 39d
Cleared Sep 25, 1981
KONTRON PMS 7000
K812354 · DQK
Kontron Instruments, Inc.
Cardiovascular · 37d
Cleared Sep 25, 1981
2000 SERIES PORTABLE RESUSCITATION SYST.
K812519 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 23d
Cleared Sep 25, 1981
280/4 MINI-DEFIBRILLATOR
K812520 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 23d
Cleared Sep 25, 1981
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
K812563 · DYG
American Edwards Laboratories
Cardiovascular · 17d
Cleared Sep 23, 1981
CYBERLITH IX IMPLANTABLE PULSE GENERATOR
K801337 · DXY
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
TELEMETRY DECODER
K801339 · DXY
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY
K811464 · DXH
Intermedics, Inc.
Cardiovascular · 120d
Cleared Sep 23, 1981
MEDTRONIC MODEL 2409
K812580 · DXY
Medtronic Vascular
Cardiovascular · 13d
Cleared Sep 21, 1981
PORTAPULSE
K812131 · DRT
Gavon, Inc.
Cardiovascular · 55d
Cleared Sep 21, 1981
NIVP MONITOR
K812259 · DXN
Datascope Corp.
Cardiovascular · 40d
Cleared Sep 21, 1981
USCI TRANSTHORACIC TEMP. PACING ELECTROD
K812307 · LDF
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Sep 21, 1981
DEFIBRILLATOR/MONITOR
K812317 · LDD
Hewlett-Packard Co.
Cardiovascular · 35d
Cleared Sep 21, 1981
INTK-08 8 FRENCH INTRODUCER KIT W/SIDE
K812325 · DYB
Sorensen Research
Cardiovascular · 35d
Cleared Sep 16, 1981
CARDIACMONITORS
K811425 · DRT
Pulse Time Products, Ltd.
Cardiovascular · 117d
Cleared Sep 16, 1981
MANUFACTURING PROCESS CHANGE
K811441 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 117d
Cleared Sep 16, 1981
GORE-TEX CARDIOVASCULAR PATCH
K811841 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Sep 16, 1981
MEDTRONIC ENERTRAX MODEL 7100
K812096 · DXY
Medtronic Vascular
Cardiovascular · 54d