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
15313–15336 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 04, 1984
BALLOON DILATION CATHETER
K843501 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 28d
Cleared Oct 02, 1984
MODELS 78551A 78552A
K841256 · DXG
Hewlett-Packard Co.
Cardiovascular · 214d
Cleared Oct 02, 1984
HEART RATE/RESPIRATION SIMULATOR 8310
K841363 · DRT
Aequitron Medical, Inc.
Cardiovascular · 183d
Cleared Oct 01, 1984
GORE-TEX VASCULAR GRAFT, FEP-RINGED
K842144 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 124d
Cleared Sep 27, 1984
PROGRAMMABLE STIMULATOR 5326
K843718 · JOQ
Medtronic Vascular
Cardiovascular · 3d
Cleared Sep 24, 1984
ELECTRODE PACEMAKER, PERM & TEMP
K840668 · DTB
Vitatron Medical BV
Cardiovascular · 237d
Cleared Sep 24, 1984
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K842364 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 98d
Cleared Sep 24, 1984
LIFELINE TLE 476-04
K843393 · DTB
Intermedics, Inc.
Cardiovascular · 26d
Cleared Sep 24, 1984
LIFELINE TLE 484-02
K843394 · DTB
Intermedics, Inc.
Cardiovascular · 26d
Cleared Sep 21, 1984
12SSL-SC
K842308 · LOS
Marquette Electronics, Inc.
Cardiovascular · 101d
Cleared Sep 20, 1984
SERVOMED MEDIVISION SCOPE SMV-235
K840209 · DXJ
Litton Medical Electronics
Cardiovascular · 245d
Cleared Sep 20, 1984
SERVOMED OXCARDIORE SPIROGRAPH 324/111
K840832 · DRT
Litton Medical Electronics
Cardiovascular · 209d
Cleared Sep 20, 1984
SENTRA
K843060 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Sep 20, 1984
ARROW-JOHANS ECG ADAPTOR
K843263 · DQY
Arrow Intl., Inc.
Cardiovascular · 31d
Cleared Sep 11, 1984
FUKUDA DENSHI FX-302 AUTO/THREE CHAN
K833594 · DRT
Brentwood Instruments, Inc.
Cardiovascular · 335d
Cleared Sep 11, 1984
HOLTER SCREENING MONITOR HS-221
K842462 · DRT
Advantage Medical Systems, Inc.
Cardiovascular · 81d
Cleared Sep 11, 1984
ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD
K843261 · DRE
Angiosystems, Inc.
Cardiovascular · 22d
Cleared Sep 06, 1984
MONITORING KIT
K833171 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 356d
Cleared Sep 04, 1984
TELECTRONICS MODEL 2401
K831697 · DTC
Seamed Corp.
Cardiovascular · 468d
Cleared Sep 04, 1984
CARDIONOSTICS HOLTER DURA-LITE RECORDE
K842954 · DSH
Cardionostics, Inc.
Cardiovascular · 39d
Cleared Sep 04, 1984
CRITIKON HEPARIN-COATED CARDIOVASCULAR
K843141 · LDF
Critikon Company, LLC
Cardiovascular · 26d
Cleared Sep 04, 1984
ND. YAG LASER FOR ENDOBRONCHIAL OBSTRUC
K843228
Endo Lase, Inc.
Cardiovascular · 19d
Cleared Aug 29, 1984
MEDTRONIC 8437/8438
K843089 · DXY
Medtronic Vascular
Cardiovascular · 23d
Cleared Aug 28, 1984
LIFESCOPE II
K841499 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 140d