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
3697–3720 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 15, 2015
CareEvent
K142935 · MSX
Philips Medical Systems
Cardiovascular · 98d
Cleared Jan 15, 2015
SUPER SHEATH
K141070 · DRE
Togo Medikit Co., Ltd.
Cardiovascular · 265d
Cleared Jan 14, 2015
ADROIT Guiding Catheter
K143412 · DQY
Cordis Corporation
Cardiovascular · 47d
Cleared Jan 12, 2015
Surefire Infusion System 021
K143588 · DQO
Surefire Medical, Inc.
Cardiovascular · 25d
Cleared Jan 12, 2015
Presto Inflation Device
K143522 · MAV
C.R. Bard, Inc.
Cardiovascular · 31d
Cleared Jan 09, 2015
CARDIOGARD EMBOLI PROTECTION CANNULA
K141465 · DWF
Cardiogard Medical, Ltd.
Cardiovascular · 220d
Cleared Jan 09, 2015
MENNTOR X7
K141441 · DSI
Mennen Medical , Ltd.
Cardiovascular · 221d
Cleared Jan 09, 2015
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
K133130 · DQO
Cook, Inc.
Cardiovascular · 466d
Cleared Jan 08, 2015
IntellaMap Orion High Resolution Mapping Catheter
K143481 · DRF
Rhythmia Medical, Inc.
Cardiovascular · 31d
Cleared Jan 07, 2015
DLP Vein Graft Cannula
K143107 · DWF
Medtronic, Inc.
Cardiovascular · 70d
Cleared Jan 07, 2015
Unity Network ID
K142840 · MWI
Ge Healthcare
Cardiovascular · 99d
Cleared Jan 07, 2015
PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
K142447 · DXZ
Synovis Life Technologies, Inc.
Cardiovascular · 127d
Cleared Jan 07, 2015
ENDOPHYS BLOOD PRESSURE MONITOR
K141615 · DSK
Endophys, Inc.
Cardiovascular · 205d
Cleared Jan 07, 2015
ENDOPHYS PRESSURE SENSING SHEATH KIT
K141275 · DYB
Endophys, Inc.
Cardiovascular · 236d
Cleared Dec 22, 2014
Passage Hemostasis Valve
K143429 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 21d
Cleared Dec 22, 2014
Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)
K143195 · MHX
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 46d
Cleared Dec 22, 2014
Carnation Ambulatory Monitor
K143067 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 59d
Cleared Dec 19, 2014
1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix...
K143328 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 29d
Cleared Dec 19, 2014
Full Automatic (NIBP) Blood Pressure Monitor
K142968 · DXN
Health & Life Co., Ltd.
Cardiovascular · 66d
Cleared Dec 19, 2014
RhythmView Workstation
K142901 · DQK
Topera, Inc.
Cardiovascular · 66d
Cleared Dec 19, 2014
LIFEPAK 15 monitor/defibrillator
K142430 · MKJ
Physio-Control, Inc.
Cardiovascular · 112d
Cleared Dec 19, 2014
Hi-Torque JET Guide Wire Family
K142415 · DQX
Abbott Vascular, Inc.
Cardiovascular · 113d
Cleared Dec 19, 2014
Connex Spot Monitor,901058 Vital Signs Monitor Core
K142356 · MWI
Welch Allyn, Inc.
Cardiovascular · 116d
Cleared Dec 19, 2014
FIRSTSTIC N INTRODUCER
K141969 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 151d