FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
6697–6720 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 08, 2007
INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0
K062894 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 134d
Cleared Feb 06, 2007
XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5,...
K063840 · MWI
Witt Biomedical Corp
Cardiovascular · 42d
Cleared Feb 06, 2007
STARCLOSE HEX-HUB DILATOR
K062554 · DRE
Abbott Vascular, Inc.
Cardiovascular · 160d
Cleared Feb 05, 2007
KODEA, MODELS XJ-2001AC
K062893 · DXN
Shanghai Kodea Economic and Trade...
Cardiovascular · 131d
Cleared Feb 05, 2007
SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
K062098 · MHX
Datascope Corp.
Cardiovascular · 196d
Cleared Feb 01, 2007
FINOMETER MODEL-2 WITH ACCESSORIES
K063111 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 113d
Cleared Jan 26, 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC
K063819 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
Cleared Jan 26, 2007
LIFEPAK 12 DEFIBRILLATOR/MONITOR
K063510 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 67d
Cleared Jan 25, 2007
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
K063586 · DPT
Moor Instruments, Ltd.
Cardiovascular · 55d
Cleared Jan 25, 2007
SENTINEL
K062397 · DXH
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 162d
Cleared Jan 25, 2007
PHASE 3, MODEL DT-1
K062099 · DRL
Datrend Systems, Inc.
Cardiovascular · 185d
Cleared Jan 19, 2007
SPIDERFX EMBOLIC PROTECTION DEVICE
K063785 · NFA
Ev3, Inc.
Cardiovascular · 29d
Cleared Jan 19, 2007
MOORLDLS LASER DOPPLER LINE SCANNER
K063561 · DPT
Moor Instruments, Ltd.
Cardiovascular · 53d
Cleared Jan 19, 2007
RADIFOCUS GLIDEWIRE ADVANTAGE
K063372 · DQX
Terumo Medical Corp.
Cardiovascular · 72d
Cleared Jan 19, 2007
THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02
K062868 · DQY
Flowcardia, Inc.
Cardiovascular · 116d
Cleared Jan 19, 2007
A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
K062027 · DXN
A&D Engineering, Inc.
Cardiovascular · 185d
Cleared Jan 19, 2007
LUNDERQUIST WIRE GUIDE
K061670 · DQX
William Cook Europe Aps
Cardiovascular · 219d
Cleared Jan 18, 2007
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
K062877 · DQO
Vascular Solutions, Inc.
Cardiovascular · 114d
Cleared Jan 12, 2007
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
K063217 · DTK
B.Braun Medical, Inc.
Cardiovascular · 80d
Cleared Jan 12, 2007
PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20,...
K061678 · DRF
Prorhythm
Cardiovascular · 211d
Cleared Jan 11, 2007
HEARTSTART MRX, MODELS M3535A OR M3536A
K063375 · MKJ
Philips Medical Systems
Cardiovascular · 64d
Cleared Jan 11, 2007
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN...
K063255 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 76d
Cleared Jan 05, 2007
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300...
K063525 · DSP
Datascope Corp.
Cardiovascular · 44d
Cleared Jan 05, 2007
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
K062627 · DQO
Vascular Solutions, Inc.
Cardiovascular · 122d