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
16489–16512 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 27, 1981
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · KRG
Intermedics, Inc.
Cardiovascular · 21d
Cleared Oct 23, 1981
SUCKER CARDIOTOMY RETURN, C.P. BYPASS
K812455 · DTN
Electromedics, Inc.
Cardiovascular · 56d
Cleared Oct 23, 1981
MEDTRONIC #4951
K812599 · DTB
Medtronic Vascular
Cardiovascular · 39d
Cleared Oct 23, 1981
MODEL 9408 A TELETRACE
K812703 · DXH
Medtronic Vascular
Cardiovascular · 31d
Cleared Oct 20, 1981
LYMPHA PRESS
K810338 · JOW
Mego Afek
Cardiovascular · 253d
Cleared Oct 20, 1981
PHYSIOLOGICAL PRESSURE TRANSDUCER
K812758 · DRS
Electromedics, Inc.
Cardiovascular · 19d
Cleared Oct 20, 1981
ECG MEDATAPE-601
K812763 · DSH
Hospital Equipment Service
Cardiovascular · 18d
Cleared Oct 20, 1981
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · KRB
Sorensen Research
Cardiovascular · 14d
Cleared Oct 13, 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J
K811593 · DTB
Telectronics, Inc.
Cardiovascular · 127d
Cleared Oct 13, 1981
KALOS-03
K812218 · DXY
Biotronik Sales, Inc.
Cardiovascular · 68d
Cleared Oct 13, 1981
DORROS-SPRING PRESSURIZER
K812304 · MAV
Cardiovascular Diagnostic Services
Cardiovascular · 56d
Cleared Oct 13, 1981
IMPLANTAID LEAD INTRODUCER #319-10 & 12
K812502 · DYB
Intermedics, Inc.
Cardiovascular · 42d
Cleared Oct 13, 1981
CARDIAC PACING ELECTRODES
K812517 · LDF
Medics Instrument Corp.
Cardiovascular · 41d
Cleared Oct 13, 1981
TRANSDUCER DOME
K812530 · DRS
Biomeal Corp.
Cardiovascular · 41d
Cleared Oct 13, 1981
PRE-BYPASS FILTER
K812539 · KRJ
Gelman Sciences, Inc.
Cardiovascular · 40d
Cleared Oct 13, 1981
INFANT CARIDAC MONITOR
K812674 · DRT
Electromed Intl., Ltd.
Cardiovascular · 21d
Cleared Oct 13, 1981
AMPLITONE-3
K812676 · LDE
Progressive Technology, Inc.
Cardiovascular · 21d
Cleared Oct 13, 1981
DISK
K812695
American Heartline, Inc.
Cardiovascular · 21d
Cleared Oct 06, 1981
INTERMEDICS POLY FLEX EPICARDIAL SUTURE
K812221 · DTB
Intermedics, Inc.
Cardiovascular · 60d
Cleared Oct 06, 1981
INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL
K812245 · DTB
Intermedics, Inc.
Cardiovascular · 56d
Cleared Oct 02, 1981
CARDIAC REVIEW STATION
K812515 · DXG
Diasonics, Inc.
Cardiovascular · 30d
Cleared Oct 02, 1981
VASCULAB #R12B
K812608 · DSF
Medasonics, Inc.
Cardiovascular · 17d
Cleared Oct 02, 1981
VASCULAB #VSC21
K812609 · JOM
Medasonics, Inc.
Cardiovascular · 17d
Cleared Oct 02, 1981
UNICUFF
K812639 · DXP
Frontier Products
Cardiovascular · 16d