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
5737–5760 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 16, 2009
SJM ATTUNE ANNULOPLASTY RING
K092876 · KRH
St Jude Medical
Cardiovascular · 28d
Cleared Oct 16, 2009
GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
K091781 · DQK
Mediguide, Ltd.
Cardiovascular · 121d
Cleared Oct 16, 2009
GUIDED MEASUREMENT CATHETER (GMC)
K091780 · DQO
Mediguide, Ltd.
Cardiovascular · 121d
Cleared Oct 15, 2009
MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6
K092177 · NTE
Invatec S.P.A.
Cardiovascular · 86d
Cleared Oct 15, 2009
STENT GRAFT BALLOON CATHETER
K091624 · DQY
Via Biomedical, Inc.
Cardiovascular · 134d
Cleared Oct 15, 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM,...
K091458 · MJN
Ev3 Neurovascular
Cardiovascular · 150d
Cleared Oct 15, 2009
LIFEBRIDGE B2T, MODEL 7001
K090006 · DTQ
Lifebridge Medizintechnik AG
Cardiovascular · 286d
Cleared Oct 14, 2009
RHYTHM OF LIFE, MODEL R0901-05
K092408 · LIX
Rapid Response Solutions, LLC
Cardiovascular · 69d
Cleared Oct 14, 2009
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
K091703 · QEZ
Concentric Medical, Inc.
Cardiovascular · 126d
Cleared Oct 13, 2009
DISPOSAL ECG ELECTRODES, MODEL EASYRODE
K092389 · DRX
Suzuken Co., Ltd.
Cardiovascular · 69d
Cleared Oct 13, 2009
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
K090017 · DQK
Biosense Webster, Inc.
Cardiovascular · 284d
Cleared Oct 09, 2009
EP-WORKMATE SYSTEM, VERSION 4.2
K092810 · DQK
St Jude Medical
Cardiovascular · 28d
Cleared Oct 09, 2009
AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
K092806 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 28d
Cleared Oct 09, 2009
AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)
K092432 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 63d
Cleared Oct 09, 2009
RADIANALYZER XPRESS
K092105 · DQK
Radi Medical Systems AB
Cardiovascular · 87d
Cleared Oct 09, 2009
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
K091584 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 129d
Cleared Oct 08, 2009
MAXIFLO, TAPERFLO
K092863 · DSY
Vascutek, Ltd.
Cardiovascular · 21d
Cleared Oct 08, 2009
ENGAGE/ENGAGE TR
K092575 · DYB
St Jude Medical
Cardiovascular · 48d
Cleared Oct 08, 2009
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
K092509 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 52d
Cleared Oct 08, 2009
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
K092014 · DYB
Onset Medical Corporation
Cardiovascular · 94d
Cleared Oct 08, 2009
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
K090051 · KFM
Levitronix, LLC
Cardiovascular · 274d
Cleared Oct 02, 2009
LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
K092037 · DRT
Hoana Medical, Inc.
Cardiovascular · 88d
Cleared Oct 01, 2009
GUARDIAN II HEMOSTASIS VALVE
K092711 · DTL
Zerusa Limited
Cardiovascular · 28d
Cleared Oct 01, 2009
CARTO RMT EP NAVIGATION SYSTEM V8
K091789 · DQK
Biosense Webster, Inc.
Cardiovascular · 106d