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
3793–3816 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 06, 2014
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial...
K142640 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 50d
Cleared Nov 06, 2014
ZOLL E SERIES ALS
K140502 · LDD
ZOLL Medical Corporation
Cardiovascular · 252d
Cleared Nov 05, 2014
SPEX SUPPORT CATHETER
K141649 · DQY
Reflow Medical
Cardiovascular · 138d
Cleared Nov 04, 2014
Unimed Disposable ECG lead wires
K142489 · DSA
Unimed Medical Supplies, Inc.
Cardiovascular · 61d
Cleared Oct 31, 2014
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
K142088 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 91d
Cleared Oct 30, 2014
VC150 VITAL SIGNS MONITOR
K133810 · MWI
Innokas Yhtyma
Cardiovascular · 318d
Cleared Oct 29, 2014
EpiAccess System
K142245 · DYB
Epiep, Inc.
Cardiovascular · 77d
Cleared Oct 29, 2014
Ascendra Balloon Aortic Valvaloplasty Catheter
K142199 · OZT
Edwards Lifesciences
Cardiovascular · 79d
Cleared Oct 28, 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · LIT
Covidien, LLC
Cardiovascular · 40d
Cleared Oct 28, 2014
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K142084 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 89d
Cleared Oct 28, 2014
EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING...
K141686 · DWJ
Smith Medical Asd, Inc.
Cardiovascular · 127d
Cleared Oct 28, 2014
HYPERQ ACS-100 SYSTEM
K140020 · DPS
Bsp-Biiological Signal Processing, Ltd.
Cardiovascular · 298d
Cleared Oct 27, 2014
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
K141809 · DRM
Defibtech, LLC
Cardiovascular · 112d
Cleared Oct 24, 2014
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
K142784 · DTZ
Medtronic, Inc.
Cardiovascular · 28d
Cleared Oct 24, 2014
RENOVOCATH RC120
K141175 · MJN
Renovorx, Inc.
Cardiovascular · 171d
Cleared Oct 23, 2014
Vasc Band hemostat
K142359 · DXC
Lepu Medical Technology (Beijing)...
Cardiovascular · 59d
Cleared Oct 23, 2014
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
K141339 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 155d
Cleared Oct 23, 2014
TRI-OPTIC MEASUREMENT CELL
K133157 · DRY
Medtronic, Inc.
Cardiovascular · 371d
Cleared Oct 17, 2014
Antegrade LeMills Valvulotome
K142660 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 29d
Cleared Oct 16, 2014
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · MCW
Covidien, LLC
Cardiovascular · 105d
Cleared Oct 16, 2014
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
K140543 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 226d
Cleared Oct 10, 2014
SOFIA DISTAL ACCESS CATHETER
K142014 · DQY
MicroVention, Inc.
Cardiovascular · 78d
Cleared Oct 10, 2014
ONESTEP CPR II MULTI-FUNCTION ELECTRODE
K133441 · MKJ
Bio-Detek, Inc.
Cardiovascular · 332d
Cleared Oct 09, 2014
BLOOD PRESSURE MONITOR
K141416 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 133d