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
4297–4320 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 03, 2013
IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
K123074 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 275d
Cleared Jul 02, 2013
VIDA PTV DILATATON CATHETER
K131002 · OMZ
C.R. Bard, Inc.
Cardiovascular · 83d
Cleared Jul 02, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
K123803 · KRD
Reverse Medical Corporation
Cardiovascular · 204d
Cleared Jul 01, 2013
CIRONA DVT FOOT GARMENT
K131743 · JOW
Devon Medical, Inc.
Cardiovascular · 18d
Cleared Jul 01, 2013
HEATER-COOLER UNIT HCU 40
K130300 · DWC
Maquet Cardiopulmonary, AG
Cardiovascular · 144d
Cleared Jun 28, 2013
ZOE FLUID STATUS MONITOR
K131509 · DSB
Noninvasive Medical Technologies, Inc.
Cardiovascular · 35d
Cleared Jun 28, 2013
CODA BALLOON CATHETER
K122917 · DQY
Cook, Inc.
Cardiovascular · 276d
Cleared Jun 26, 2013
MONITOR B40
K130584 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 113d
Cleared Jun 25, 2013
PRIMI AND SECONDI SUPPORT CATHETERS
K130850 · DQY
Thermopeutix, Inc.
Cardiovascular · 90d
Cleared Jun 25, 2013
EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
K121628 · DXH
Epi Mobile Health Solutions (S) Pte,...
Cardiovascular · 386d
Cleared Jun 24, 2013
CARDIOSLEEVE
K131287 · DQD
Rijuven Corp
Cardiovascular · 49d
Cleared Jun 24, 2013
STEALTH 360 ORBITAL PAD SYSTEM
K131092 · MCW
Cardio Systems, Inc.
Cardiovascular · 67d
Cleared Jun 24, 2013
LAWMAX DILATOR
K123842 · DRE
Lifetech Scientific (Shenzhen) Co., Ltd.
Cardiovascular · 193d
Cleared Jun 21, 2013
VERRATA PRESSURE GUIDE WIRE
K131288 · DQX
Volcano Corporation
Cardiovascular · 46d
Cleared Jun 21, 2013
BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)
K124038 · MWI
Bedside Clinical Systems, Inc.
Cardiovascular · 175d
Cleared Jun 21, 2013
MFM-CMS CENTRAL MONITORING SYSTEM
K120727 · MHX
Edan Instruments, Inc.
Cardiovascular · 469d
Cleared Jun 20, 2013
AIRCAST VENAFLOW ELITE SYSTEM
K130722 · JOW
Djo, LLC
Cardiovascular · 94d
Cleared Jun 20, 2013
ARROW GPSCATH BALLOON DILATATION CATHETER
K130397 · LIT
Hotspur Technologies
Cardiovascular · 121d
Cleared Jun 20, 2013
PHYSIOLOGICAL DATA PROCESSOR
K122763 · DRG
Zephyr Technology Corporation
Cardiovascular · 283d
Cleared Jun 19, 2013
TRANSTEK BLOOD PRESSURE MONITOR
K131395 · DXN
Guangdong Transtek Medical...
Cardiovascular · 35d
Cleared Jun 19, 2013
BASIXTOUCH
K130566 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 107d
Cleared Jun 19, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K130564 · DXN
Health & Life Co., Ltd.
Cardiovascular · 107d
Cleared Jun 18, 2013
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
K131193 · JOW
Tactile Systems Technology, Inc.
Cardiovascular · 53d
Cleared Jun 18, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K130563 · DXN
Health & Life Co., Ltd.
Cardiovascular · 106d