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
6241–6264 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 01, 2008
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K080813 · DXO
Radi Medical Systems AB
Cardiovascular · 102d
Cleared Jun 30, 2008
SENSEI CATHETER CONTROL SYSTEM
K073225 · DXX
Hansen Medical, Inc.
Cardiovascular · 228d
Cleared Jun 27, 2008
MEDTRONIC EXPORT AP CATHETER
K081573 · DXE
Medtronic Vascular
Cardiovascular · 22d
Cleared Jun 27, 2008
HERO, VERSION 2.0
K081473 · DPS
Medical Predictive Science Corp.
Cardiovascular · 31d
Cleared Jun 27, 2008
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
K081049 · DRA
Cryocath Technologies, Inc.
Cardiovascular · 74d
Cleared Jun 27, 2008
INTEL HEALTH GUIDE, MODEL: PHS6000
K080798 · DRG
Intel Corp.
Cardiovascular · 99d
Cleared Jun 27, 2008
ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
K073631 · KFM
Orqis Medical Corporation
Cardiovascular · 184d
Cleared Jun 26, 2008
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K081467 · QEY
Ekos Corp.
Cardiovascular · 30d
Cleared Jun 24, 2008
ECARD AND CCARD
K081471 · DXH
iRhythm Technologies, Inc.
Cardiovascular · 28d
Cleared Jun 23, 2008
BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5
K073280 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 215d
Cleared Jun 20, 2008
HORIZON XVU
K081484 · DQK
Mennen Medical , Ltd.
Cardiovascular · 23d
Cleared Jun 20, 2008
CROSSER LP SYSTEM
K080765 · DQX
Flowcardia, Inc.
Cardiovascular · 94d
Cleared Jun 20, 2008
APEXPRO TELEMETRY SYSTEMS
K080251 · MHX
Ge Medical Systems Information...
Cardiovascular · 141d
Cleared Jun 20, 2008
PATIENT CABLE
K080112 · DSA
Med-Dyne
Cardiovascular · 156d
Cleared Jun 19, 2008
YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R,...
K081590 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 13d
Cleared Jun 19, 2008
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
K081221 · DWA
Levitronix, LLC
Cardiovascular · 50d
Cleared Jun 18, 2008
OCCLUSION BALLOON CATHETER, MODEL VENOS
K081052 · DYG
Oscor, Inc.
Cardiovascular · 65d
Cleared Jun 17, 2008
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
K080034 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 162d
Cleared Jun 13, 2008
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
K081454 · MJN
Possis Medical, Inc.
Cardiovascular · 21d
Cleared Jun 09, 2008
DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
K080366 · DXQ
Zefon Intl.
Cardiovascular · 118d
Cleared Jun 06, 2008
TR-USB TELEPHONIC STETHOSCOPE
K081032 · DQD
Rnk Products, Inc.
Cardiovascular · 56d
Cleared Jun 06, 2008
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
K073712 · DWJ
Adroit Medical Systems, Inc.
Cardiovascular · 158d
Cleared Jun 04, 2008
FOXCROSS PTA CATHETER
K081417 · LIT
Abbott Vascular, Inc.
Cardiovascular · 15d
Cleared May 30, 2008
AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND...
K081035 · DSB
Osypka Medical, Inc.
Cardiovascular · 49d