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
15577–15600 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 04, 1984
VERTEX PERCUTANEOUS CATHETER INTRODUC
K840017 · DRE
Professional Medical Services
Cardiovascular · 31d
Cleared Feb 04, 1984
HEART CATHETERIZATION TRAY SET
K840022 · DRE
Medi-Plast Intl., Inc.
Cardiovascular · 30d
Cleared Feb 04, 1984
LIFEPAK 7D
K840047 · DRO
Physio-Control Corp.
Cardiovascular · 29d
Cleared Feb 04, 1984
ELECATH HEPARIN COATED TEMP. PACING
K840109 · LDF
Electro-Catheter Corp.
Cardiovascular · 25d
Cleared Feb 04, 1984
PORTABLE DEFIBRILLATOR
K840167 · LDD
Honeywell, Inc.
Cardiovascular · 19d
Cleared Jan 30, 1984
LIFEPAK 7P
K832876 · DRO
Physio-Control Corp.
Cardiovascular · 157d
Cleared Jan 30, 1984
PROGRAMMABLE STIMULATOR 2352
K833421 · JOQ
Medtronic Vascular
Cardiovascular · 119d
Cleared Jan 30, 1984
PULSE GENERATOR MODEL 688
K833519 · DXY
Burditt & Calkins-Siemens-Elema
Cardiovascular · 111d
Cleared Jan 30, 1984
HEPARIN-COATED BALLOON THERMODILUT
K833572 · DYG
Critikon Company, LLC
Cardiovascular · 110d
Cleared Jan 30, 1984
VERIFORM II
K833583 · DXN
American Medical Systems, Inc.
Cardiovascular · 110d
Cleared Jan 30, 1984
VITAL SIGNS MONITOR 3
K833584 · DPS
Physio-Control Corp.
Cardiovascular · 110d
Cleared Jan 30, 1984
AC ADAPTERS FOR BLOOD PRESSURE METERS
K833753 · DXN
Philips Park
Cardiovascular · 83d
Cleared Jan 30, 1984
INFUSION PORT BALLOON THERMODILUTION
K833918 · DYG
Critikon Company, LLC
Cardiovascular · 77d
Cleared Jan 30, 1984
CARDIOTOMY RESERVOIR SC3500F
K834041 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Jan 30, 1984
CARDIODATA PACE RECORDER
K834257 · DSH
Cardio Data
Cardiovascular · 54d
Cleared Jan 30, 1984
ELECTRODE LEAD CONSTRUCTION
K834533 · DTB
Telectronics, Inc.
Cardiovascular · 39d
Cleared Jan 27, 1984
MAX I
K831763 · DQD
Trade Max, Inc.
Cardiovascular · 240d
Cleared Jan 27, 1984
HOLTA-MED INFORMER PLAYBACK
K832354 · DSI
Holta-Med
Cardiovascular · 193d
Cleared Jan 27, 1984
ALPHA CARDIAC OUTPUT CARDULE #1899
K832644 · DXG
Spacelabs, Inc.
Cardiovascular · 175d
Cleared Jan 27, 1984
ALPHA NON-INVASIVE BP CARDULE
K832764 · DXN
Spacelabs, Inc.
Cardiovascular · 164d
Cleared Jan 27, 1984
HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000
K833078 · DTZ
Cordis Corp.
Cardiovascular · 140d
Cleared Jan 27, 1984
TREND PROCESSOR OPTION FOR #515 NEONAT
K833552 · DRT
Ge Medical Systems Information...
Cardiovascular · 105d
Cleared Jan 27, 1984
CONDUCTANCE METER
K833619 · KRC
Circadian, Inc.
Cardiovascular · 105d
Cleared Jan 27, 1984
ADULT MONITORING ELECTOR@@RODE 9431-300
K833695 · DRX
Marquette Electronics, Inc.
Cardiovascular · 101d