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
15529–15552 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 12, 1984
3-DAY BIOINDICATOR RELEASE PROCESS FOR
K833830 · DWF
Shiley, Inc.
Cardiovascular · 157d
Cleared Apr 10, 1984
NORELCO ELECTRONIC DIGITAL BP METER
K841489
North American Philips Corp.
Cardiovascular
Cleared Apr 06, 1984
ABM ANESTHESIA & BRAIN MONITOR
K840232
Datex Division Instrumentarium Corp.
Cardiovascular · 87d
Cleared Apr 01, 1984
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445 · DRX
Graphic Controls Corp.
Cardiovascular · 107d
Cleared Mar 26, 1984
CSPI ROTARY SURGICAL ASPIRATOR
K841383
Custom Surgical Products, Inc.
Cardiovascular
Cleared Mar 23, 1984
CSPI PREMIUM SURGICAL ASPIRATOR
K841242
Custom Surgical Products, Inc.
Cardiovascular
Cleared Mar 22, 1984
SERVOMED COMPACT MONITOR SMK 155-7/101
K832025 · DRT
Litton Medical Electronics
Cardiovascular · 273d
Cleared Mar 22, 1984
SEVOMED COMPACT MONITOR SMK 154-
K832095 · DRT
Litton Medical Electronics
Cardiovascular · 268d
Cleared Mar 22, 1984
MODEL TTPM TIME TEMP. PRESSURE MONITOR
K832897 · DRS
Electromedics, Inc.
Cardiovascular · 213d
Cleared Mar 22, 1984
HEMODYNAMIC PLUG-IN MODULE 78551A
K833913 · DXG
Hewlett-Packard Co.
Cardiovascular · 129d
Cleared Mar 22, 1984
CARDIAC OUTPUT SIGNAL ACQUISTION
K833914 · DXG
Hewlett-Packard Co.
Cardiovascular · 129d
Cleared Mar 19, 1984
SURGICAL VESSEL DILATORS-CATHERIZA-
K833676 · DWP
Cimed Intl., Inc.
Cardiovascular · 157d
Cleared Mar 19, 1984
PERCUTANEOUS SHEATH INTRODUCER TRAY
K834074 · DYB
Packaging Technologies, Inc.
Cardiovascular · 115d
Cleared Mar 13, 1984
FCP-11ECG
K842169
Brentwood Instruments, Inc.
Cardiovascular
Cleared Mar 12, 1984
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831926 · DTG
Oscor, Inc.
Cardiovascular · 271d
Cleared Mar 12, 1984
VASCULAR RECORDER #301
K832369 · JOP
Imex Medical Systems, Inc.
Cardiovascular · 241d
Cleared Mar 12, 1984
MATERIAL ADDITION LEXAN & K-RESIN
K833554 · DQO
Procedure Products, Inc.
Cardiovascular · 159d
Cleared Mar 12, 1984
RIGHT CORONARY GUIDING CATHETER
K833801 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 132d
Cleared Mar 12, 1984
PACING ELECTRODE
K834431 · DTB
Pacesetter Systems
Cardiovascular · 87d
Cleared Mar 12, 1984
STEIGER TUNNELING INSTRUMENT 285
K840529 · DRC
Evermed, Inc.
Cardiovascular · 33d
Cleared Mar 12, 1984
CARDIAC CATHETERIZATION PACK
K840671 · DRE
Professional Medical Services
Cardiovascular · 20d
Cleared Mar 09, 1984
OMEGA 5000
K833978 · DXN
Invivo Research Labs, Inc.
Cardiovascular · 113d
Cleared Feb 28, 1984
FILTECH TECHNETIUM-99MM RADIOPHARMACEU
K833686
Summa Medical Corp.
Cardiovascular · 120d
Cleared Feb 27, 1984
PATIENT MONITOR 78534B
K840251 · DRT
Hewlett-Packard Co.
Cardiovascular · 54d