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
6457–6480 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 09, 2007
CXI SUPPORT CATHETER
K072724 · KRA
Cook, Inc.
Cardiovascular · 44d
Cleared Nov 09, 2007
VIAPEEL PEELABLE INTRODUCER
K072248 · DYB
Enpath Medical, Inc.
Cardiovascular · 88d
Cleared Nov 09, 2007
OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER
K072156 · DQY
Usci Ireland
Cardiovascular · 98d
Cleared Nov 09, 2007
CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
K071918 · DWJ
Thermogear, Inc.
Cardiovascular · 120d
Cleared Nov 09, 2007
THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910
K071826 · QEZ
Fox Hollow Technologies
Cardiovascular · 129d
Cleared Nov 09, 2007
TESLA GUARD, MODEL EFT G04
K071802 · MWI
Mammendorfer Institut Fur Physik Und...
Cardiovascular · 130d
Cleared Nov 08, 2007
GUNTHER TULIP VENA CAVA FILTER
K072240 · DTK
Cook, Inc.
Cardiovascular · 87d
Cleared Nov 06, 2007
ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE
K072430 · MKJ
ZOLL Medical Corporation
Cardiovascular · 69d
Cleared Nov 06, 2007
AUSCO ES-3100
K070550 · DQD
Koratek Company, Ltd.
Cardiovascular · 252d
Cleared Nov 05, 2007
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
K072666 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 45d
Cleared Nov 02, 2007
VENDYS, MODEL 6000 B B/C
K072919 · DQK
Endothelix, Inc.
Cardiovascular · 18d
Cleared Nov 02, 2007
AMPLATZER TORQVUE DELIVERY SYSTEM
K072313 · DQY
Aga Medical Corp.
Cardiovascular · 77d
Cleared Nov 02, 2007
TEXTRONICS ECG ELECTRODE
K071576 · DRX
Textronics, Inc.
Cardiovascular · 147d
Cleared Oct 31, 2007
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
K072990 · NTE
Medtronic, Inc.
Cardiovascular · 7d
Cleared Oct 31, 2007
PTFE PEEL AWAY MICROINTRODUCER
K072130 · DYB
Intromed
Cardiovascular · 90d
Cleared Oct 31, 2007
GALTSTICK INTRODUCER SYSTEM
K071330 · DRE
Galt Medical Corp.
Cardiovascular · 173d
Cleared Oct 29, 2007
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL...
K072091 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 91d
Cleared Oct 26, 2007
STIMLAB
K072200 · JOQ
Micropace Pty, Ltd.
Cardiovascular · 79d
Cleared Oct 26, 2007
RNK ELECTRONIC STETHOSCOPE
K072026 · DQD
Rnk Products, Inc.
Cardiovascular · 94d
Cleared Oct 25, 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K072800 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 24d
Cleared Oct 24, 2007
ESTECH PERCUTANEOUS INSERTION DILATOR KIT
K070749 · DRE
Coombs Medical Device Consulting
Cardiovascular · 219d
Cleared Oct 23, 2007
FOX SV PTA CATHETER
K072824 · LIT
Abbott Laboratories
Cardiovascular · 21d
Cleared Oct 23, 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J
K072705 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Oct 23, 2007
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
K072655 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 33d