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
15121–15144 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 14, 1985
PTCA BALLOON CATHETERS & ACCESSORIES
K843944 · LOX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 128d
Cleared Feb 14, 1985
PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD
K844857 · DTD
Pacesetter Systems
Cardiovascular · 62d
Cleared Feb 14, 1985
SPACELABS MODEL 90201 HOLTER RECORDER
K844940 · DSH
Spacelabs, Inc.
Cardiovascular · 56d
Cleared Feb 14, 1985
HEART AID MODEL 97
K850170 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 29d
Cleared Feb 13, 1985
COPAL DIGITAL SPHYGMOMANOMETER UA-510
K842388 · DXN
Takeda Medical, Inc.
Cardiovascular · 240d
Cleared Feb 13, 1985
COMPUTER
K844665 · DXG
Burdick Corp.
Cardiovascular · 75d
Cleared Feb 13, 1985
LIFESOUND - ELECTRONIC STETHOSCOPE
K844804 · DQD
Biomedical Concepts, Inc.
Cardiovascular · 64d
Cleared Feb 12, 1985
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740 · LDD
Hewlett-Packard Co.
Cardiovascular · 69d
Cleared Feb 12, 1985
SIREDOC, PAPER CHART RECORDER
K850146 · DSF
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Feb 08, 1985
IABP #90 SYSTEM
K831235 · DSP
Datascope Corp.
Cardiovascular · 665d
Cleared Feb 08, 1985
PERCOR 9.5 FR IAB ON DATASCOPE CO2
K833828 · DSP
Datascope Corp.
Cardiovascular · 464d
Cleared Feb 08, 1985
BIOPATCH BOVINE PERICARDIAL PATCH
K840756 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 351d
Cleared Feb 08, 1985
MDE ESCORT 1000 & MDE ESCOR 2000
K842716 · DXH
Medical Data Electronics
Cardiovascular · 210d
Cleared Feb 08, 1985
COPAL DIGITAL SPHYGMOMANOMETER UA-540
K844284 · DXN
Takeda Medical, Inc.
Cardiovascular · 95d
Cleared Feb 08, 1985
SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR
K844793 · DXY
Intermedics, Inc.
Cardiovascular · 60d
Cleared Feb 08, 1985
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR
K844957 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Feb 08, 1985
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE
K844958 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Feb 08, 1985
CARDIOBEEPER PROFILE MONITOR
K844966 · DXH
Survival Technology, Inc.
Cardiovascular · 46d
Cleared Feb 08, 1985
ELECTROCARDIOGRAPH-ECG CALIPER
K850021 · DPS
Devcom, Inc.
Cardiovascular · 36d
Cleared Feb 08, 1985
CARDIOGUARD STRESS TEST MONITOR 4002
K850043 · DRT
Del Mar Avionics
Cardiovascular · 32d
Cleared Feb 08, 1985
C/PES 9103, ECG STRESS TESTING SYSTEM
K850113 · DRT
Gould, Inc.
Cardiovascular · 25d
Cleared Feb 07, 1985
QUIKPAGE ARRHYTHMIA REPORT GENERATOR
K841083 · DSI
Agilent Technologies
Cardiovascular · 331d
Cleared Feb 07, 1985
BIOTRONIK DNP UNIPOLAR
K841450 · DTD
Biotronik Sales, Inc.
Cardiovascular · 304d
Cleared Feb 07, 1985
BIOTRONIK DY-UNIPOLAR
K841451 · DTD
Biotronik Sales, Inc.
Cardiovascular · 304d