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
4081–4104 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 23, 2014
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
K132928 · DXT
Medrad, Inc. / Bayer Medical Care, Inc.
Cardiovascular · 127d
Cleared Jan 22, 2014
ZOE FLUID STATUS MONITOR
K133301 · DSB
Noninvasive Medical Technologies, Inc.
Cardiovascular · 89d
Cleared Jan 17, 2014
PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY...
K132682 · MCW
Atheromed, Inc.
Cardiovascular · 142d
Cleared Jan 17, 2014
SMARTDOP XT
K131623 · JOP
Koven Technology, Inc.
Cardiovascular · 227d
Cleared Jan 17, 2014
OREGON SCINTIFIC
K131245 · DXN
Idt Technology Limited
Cardiovascular · 261d
Cleared Jan 16, 2014
HEM-7311
K133379 · DXN
Omron Healthcare, Inc.
Cardiovascular · 73d
Cleared Jan 16, 2014
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
K132528 · DXG
GE Healthcare Finland Oy
Cardiovascular · 157d
Cleared Jan 09, 2014
MEDOS HILITE 7000 & 7000 LT OXYGENATOR
K133261 · DTZ
Medos Medizintechnik AG
Cardiovascular · 78d
Cleared Jan 08, 2014
V-PATCH SYSTEM
K131000 · DSI
Intelesens Limited
Cardiovascular · 273d
Cleared Jan 08, 2014
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
K130843 · DRC
Oscor, Inc.
Cardiovascular · 287d
Cleared Jan 03, 2014
SIREN EPCR SUITE
K131272 · DXJ
Medusa Medical Technologies, Inc.
Cardiovascular · 245d
Cleared Dec 31, 2013
UNBALLOON NON-OCCLUSION MODELING CATHETER
K133026 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 96d
Cleared Dec 24, 2013
MOZEC - RX PTCA BALLOON DILATATION CATHETER
K131169 · LOX
Meril Life Sciences Private Limited
Cardiovascular · 244d
Cleared Dec 24, 2013
ARM AUTOMATIC BLOOD PRESSURE MONITOR
K130325 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 319d
Cleared Dec 20, 2013
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K133626 · KRD
MicroVention, Inc.
Cardiovascular · 24d
Cleared Dec 20, 2013
PRESSUREWIRE AERIS AGILE TIP
K133587 · DRG
St. Jude Medical Systems AB
Cardiovascular · 29d
Cleared Dec 20, 2013
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM,...
K133569 · OZT
Bard Peripheral Vascular, Inc.
Cardiovascular · 30d
Cleared Dec 20, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · MCW
Boston Scientific Corp
Cardiovascular · 30d
Cleared Dec 20, 2013
VIA MICROCATHETER, VIA PLUS MICROCATHETER
K132652 · DQY
Sequent Medical, Inc.
Cardiovascular · 116d
Cleared Dec 20, 2013
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K131765 · DSB
Conmed Corporation
Cardiovascular · 186d
Cleared Dec 20, 2013
BERNOULLI ENTERPRISE SOFTWARE
K130208 · MHX
Cardiopulmonary Corp.
Cardiovascular · 326d
Cleared Dec 19, 2013
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
K132623 · DQX
Medtronic
Cardiovascular · 119d
Cleared Dec 18, 2013
VISI MOBILE MONITIORING SYSTEM
K133586 · MWI
Sotera Wireless, Inc.
Cardiovascular · 27d
Cleared Dec 17, 2013
OPTION ELITE VENA CAVA FILTER SYSTEM
K133243 · DTK
Rex Medical, L.P.
Cardiovascular · 56d