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
14737–14760 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 17, 1985
GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX
K851486 · DRS
Gould, Inc.
Cardiovascular · 185d
Cleared Oct 17, 1985
SARNS EVACUPLEGE CATHETER
K853128 · DWF
3M Health Care, Sarns
Cardiovascular · 83d
Cleared Oct 16, 1985
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO
K853251 · DTZ
Johnson & Johnson Professionals, Inc.
Cardiovascular · 79d
Cleared Oct 11, 1985
IPG-300
K852238 · DSB
Thornton Associates, Inc.
Cardiovascular · 141d
Cleared Oct 11, 1985
ANGIOMEDICS SOFTIP CATHETER
K852872 · DQO
Angiomedics, Inc.
Cardiovascular · 95d
Cleared Oct 11, 1985
PACEPAC
K852958 · DRO
Medical Data Electronics
Cardiovascular · 91d
Cleared Oct 11, 1985
SHILEY CSD EXTENSION LINE WITH FILTER
K852984 · DWF
Shiley, Inc.
Cardiovascular · 88d
Cleared Oct 11, 1985
WILLIAM HARVEY HYBID OXYGENATOR H-1700
K853080 · DTZ
C.R. Bard, Inc.
Cardiovascular · 80d
Cleared Oct 11, 1985
BIO PACK MODEL 200
K853126 · DWA
Bio Medicus, Inc.
Cardiovascular · 78d
Cleared Oct 11, 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 144d
Cleared Oct 11, 1985
CARDIO DATA PACERECORDER PR3
K853262 · DSH
Cardio Data
Cardiovascular · 67d
Cleared Oct 11, 1985
MEDIC 4
K853354 · LDD
Kone Instruments, Inc.
Cardiovascular · 60d
Cleared Oct 11, 1985
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
K853410 · DTR
Intermedics, Inc.
Cardiovascular · 59d
Cleared Oct 11, 1985
MODEL 43130A DEFIBRILLATOR
K853439 · LDD
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Oct 11, 1985
LIFEPAK 200
K853564 · MKJ
Physio-Control Corp.
Cardiovascular · 46d
Cleared Oct 11, 1985
MEDTRONIC MODEL 6405
K853818 · LDF
Medtronic Vascular
Cardiovascular · 29d
Cleared Oct 09, 1985
ELECTROCARDIOGRAPH
K852181 · DPS
Armstrong Ind., Inc.
Cardiovascular · 142d
Cleared Oct 09, 1985
SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER
K852281 · DPS
Armstrong Ind., Inc.
Cardiovascular · 133d
Cleared Oct 09, 1985
SCHILLER MINISCOPE MS-2 EKG SCOPE
K852282 · DPS
Armstrong Ind., Inc.
Cardiovascular · 133d
Cleared Oct 08, 1985
LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD
K853520 · DTB
Intermedics, Inc.
Cardiovascular · 47d
Cleared Oct 02, 1985
CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO
K851517 · DSI
Circadian, Inc.
Cardiovascular · 170d
Cleared Oct 01, 1985
IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A
K852708 · DTB
Telectronics, Inc.
Cardiovascular · 97d
Cleared Oct 01, 1985
MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD
K853411 · DTB
Intermedics, Inc.
Cardiovascular · 49d
Cleared Sep 30, 1985
BIO MEDICUS BIO PUMP MODEL BP-80
K852698 · KFM
Bio Medicus, Inc.
Cardiovascular · 96d