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
4873–4896 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 27, 2012
MODEL HBP-1300
K113185 · DXN
Omron Healthcare, Inc.
Cardiovascular · 91d
Cleared Jan 26, 2012
CALG-STR EXERCISE ECG ANALYSIS ALGORITHM
K112959 · DPS
Philips Health Care
Cardiovascular · 114d
Cleared Jan 26, 2012
FORE-SIGHT ABSOLUTE TISSUE OXIMETER
K112820 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 120d
Cleared Jan 25, 2012
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
K113845 · DTL
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jan 24, 2012
GENESIS TOUCH SYSTEM
K112858 · DRG
Honeywell Hommed, LLC
Cardiovascular · 116d
Cleared Jan 20, 2012
GPSCATH BALLON DILATATION CATHETER
K113769 · LIT
Hotspur Technologies
Cardiovascular · 29d
Cleared Jan 20, 2012
DISPOSABLE HEMOSTATIC Y-CONNECTORS
K113132 · DTL
Coeur, Inc.
Cardiovascular · 88d
Cleared Jan 20, 2012
MICROFRANCE(R) WORMALD VASCULAR CLAMP
K112662 · DXC
Medtronic Xomed, Inc.
Cardiovascular · 129d
Cleared Jan 19, 2012
CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
K120010 · DSA
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 16d
Cleared Jan 19, 2012
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR
K113083 · DXN
Truly Instrument Co., Ltd.
Cardiovascular · 93d
Cleared Jan 18, 2012
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
K113773 · KRA
St Jude Medical
Cardiovascular · 27d
Cleared Jan 18, 2012
AVITA ARM TYPE BLOOD PRESSURE MONITOR
K112825 · DXN
Avita Corporation
Cardiovascular · 112d
Cleared Jan 17, 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · DSY
Boston Scientific Corporation
Cardiovascular · 90d
Cleared Jan 13, 2012
SCEPTER XC OCCLUSION BALLOON CATHETER
K113698 · MJN
MicroVention, Inc.
Cardiovascular · 28d
Cleared Jan 13, 2012
THE VENOUS ASSIST SYSTEM
K112677 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 121d
Cleared Jan 12, 2012
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
K113667 · DTL
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Jan 12, 2012
TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
K113085 · DXN
Truly Instrument Co., Ltd.
Cardiovascular · 86d
Cleared Jan 12, 2012
FUNNEL GUIDE CATHETER MODEL G1020608
K102439 · DQY
Lazarus Effect, Inc.
Cardiovascular · 504d
Cleared Jan 11, 2012
GLADIATOR PTA BALLOON DILATION CATHETER
K113681 · LIT
Boston Scientific
Cardiovascular · 27d
Cleared Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651 · KRD
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jan 05, 2012
NMI 2.8 MICROCATHETER
K113638 · DQO
Navilyst Medical, Inc.
Cardiovascular · 27d
Cleared Jan 05, 2012
VALET MICRO CATHETER
K112035 · DQY
Volcano Corporation
Cardiovascular · 174d
Cleared Jan 04, 2012
BIGBOSS CATHETER
K113589 · DQY
Bridgepoint Medical
Cardiovascular · 30d
Cleared Jan 04, 2012
AVIVO MOBILE PATIENT MANAGEMENT
K113187 · MHX
Corventis, Inc.
Cardiovascular · 65d