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
5089–5112 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 30, 2011
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
K111485 · DQX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jun 30, 2011
SIROCCO THERMAL REGULATING SYSTEM
K102856 · DWJ
Galmaz Biotech S.L.
Cardiovascular · 274d
Cleared Jun 28, 2011
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
K111658 · KFM
Medtronic, Inc.
Cardiovascular · 14d
Cleared Jun 28, 2011
VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304,...
K111180 · DSH
Vasomedical, Inc.
Cardiovascular · 62d
Cleared Jun 28, 2011
PATIENT MONITOR
K101692 · MHX
Contec Medical System Co., Ltd.
Cardiovascular · 377d
Cleared Jun 24, 2011
VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE...
K111096 · DSH
Vasomedical, Inc.
Cardiovascular · 65d
Cleared Jun 24, 2011
SENSI
K110704 · DQD
Diacoustic Medical Devices (Pty) , Ltd.
Cardiovascular · 102d
Cleared Jun 24, 2011
SUREFIRE INFUSION CATHETER SYSTEM
K110459 · DQO
Surefire Medical, Inc.
Cardiovascular · 127d
Cleared Jun 24, 2011
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
K103520 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 206d
Cleared Jun 23, 2011
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657 · KFM
Medtronic, Inc.
Cardiovascular · 9d
Cleared Jun 22, 2011
THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
K111138 · DYB
Access Scientific, Inc.
Cardiovascular · 61d
Cleared Jun 20, 2011
CENTRIMAG DRAINAGE CANNULA KIT
K110983 · DWF
Levitronix, LLC
Cardiovascular · 74d
Cleared Jun 20, 2011
CENTRIMAG RETURN CANNULA KIT
K110980 · DWF
Levitronix, LLC
Cardiovascular · 74d
Cleared Jun 16, 2011
EURO DEFI PADS ADULT
K103783 · LDD
Fiab Spa
Cardiovascular · 171d
Cleared Jun 15, 2011
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
K111307 · KRD
MicroVention, Inc.
Cardiovascular · 36d
Cleared Jun 15, 2011
VISENSIA, VISENSIA WITH ALERT
K110953 · MHX
Obs Medical
Cardiovascular · 71d
Cleared Jun 14, 2011
EV1000 CLINICAL PLATFORM
K110597 · DXG
Edwards Lifesciences
Cardiovascular · 104d
Cleared Jun 14, 2011
SPACELABS PATHFINDER SL HOLTER ANALYZER
K110001 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 162d
Cleared Jun 13, 2011
MAX PULSE SYSTEM
K110374 · JOM
Medicore Co., Ltd.
Cardiovascular · 124d
Cleared Jun 13, 2011
AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
K102507 · DSI
Tz Medical, Inc.
Cardiovascular · 285d
Cleared Jun 10, 2011
EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
K110133 · LOX
Creganna-Tactx Medical
Cardiovascular · 143d
Cleared Jun 09, 2011
ENGAGE/ENGAGE TR INTRODUCERS
K111092 · DYB
St Jude Medical
Cardiovascular · 51d
Cleared Jun 09, 2011
POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED...
K102496 · MKJ
Cardiac Science Corporation
Cardiovascular · 282d
Cleared Jun 08, 2011
MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS
K111007 · NMD
Midwest Reprocessing Center, LLC
Cardiovascular · 58d