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
16369–16392 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 22, 1982
CONPHAR, WALL ANEROID SPHYGMOMANOMETER
K813303 · DXQ
Conphar, Inc.
Cardiovascular · 60d
Cleared Jan 22, 1982
COMMAND P5
K813534 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 36d
Cleared Jan 22, 1982
MOD. 587 BLOOD PRESSURE & PULSE MONITOR
K813556 · DXN
Bio Mega Diagnostic, Inc.
Cardiovascular · 31d
Cleared Jan 22, 1982
SIEMENS-ELEMA PULSE GENERATOR 659
K813576 · DXY
Siemens Elema AB
Cardiovascular · 30d
Cleared Jan 22, 1982
INDEFLATOR
K813622 · DQO
Advanced Catheter Systems
Cardiovascular · 24d
Cleared Jan 22, 1982
SIMPSON-ROBERT CORONARY GUIDING CATHET
K813623 · DQO
Advanced Catheter Systems
Cardiovascular · 24d
Cleared Jan 22, 1982
ADVANCED CATHETER SYSTEMS CORONARY GUID
K813624 · DQO
Advanced Catheter Systems
Cardiovascular · 24d
Cleared Jan 22, 1982
ARROW JUGULAR PUNCTURE KIT 16 GA.
K820009 · DQY
Arrow Intl., Inc.
Cardiovascular · 17d
Cleared Jan 22, 1982
CARDIOSTRESS
K820011 · DPS
Instruments For Cardiac Research
Cardiovascular · 17d
Cleared Jan 22, 1982
CARDIOVUE ACCESSORY CART
K820033 · DSF
Diasonics, Inc.
Cardiovascular · 16d
Cleared Jan 18, 1982
P.E.T.
K812793 · DXH
Hospital Equipment Service
Cardiovascular · 104d
Cleared Jan 18, 1982
APC IMPLANTABLE PACING LEADS
K812807 · DTB
American Pacemaker Corp.
Cardiovascular · 104d
Cleared Jan 18, 1982
APC IMPLANTABLE PACING LEAD
K812830 · DTB
American Pacemaker Corp.
Cardiovascular · 102d
Cleared Jan 18, 1982
LPM/50 MEMBRANE OXYGENATOR
K813255 · DTZ
Travenol Laboratories, S.A.
Cardiovascular · 60d
Cleared Jan 18, 1982
PACE *AID
K813553 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 27d
Cleared Jan 18, 1982
HEMOSTATIC SIDE-ARM ADAPTER
K813578 · DYG
Advanced Catheter Systems
Cardiovascular · 26d
Cleared Jan 12, 1982
CARDIOSONIC ACOUSTIC AMPLIFIER
K813510 · LDE
Srs Co.
Cardiovascular · 28d
Cleared Jan 12, 1982
IMPLANT AID SPLICING CRIMP & SLEEVE
K813518 · KFJ
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jan 12, 1982
DINAMAP ADULT/PED./NEONATAL VITAL SIGNS
K813527 · DXN
Critikon Company, LLC
Cardiovascular · 27d
Cleared Jan 12, 1982
CONTINUOUS FLUSH DEVICE
K813549 · DRS
Namic
Cardiovascular · 22d
Cleared Jan 07, 1982
DISPOSABLE TRANSDUCER
K813464 · DRS
Sorensen Research
Cardiovascular · 27d
Cleared Jan 07, 1982
MEDIFIX
K813498 · KRK
Burron Medical Products, Inc.
Cardiovascular · 24d
Cleared Dec 29, 1981
KANTRON 504 HEARTSTATION
K812586 · LDD
Kantron Cardiovascular, Inc.
Cardiovascular · 109d
Cleared Dec 29, 1981
VITALOG PMS-8 MONITOR
K812739 · DQK
Vitalog Corp.
Cardiovascular · 91d