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
4849–4872 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 16, 2012
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS...
K110825 · MKJ
Philips Medical Systems
Cardiovascular · 330d
Cleared Feb 14, 2012
VITAL SIGNS MONITOR
K120144 · DXN
Edan Instruments, Inc.
Cardiovascular · 27d
Cleared Feb 14, 2012
VICTORY GUIDEWIRE (32 MODELS)
K120137 · DQX
Brivant, Ltd.
Cardiovascular · 28d
Cleared Feb 14, 2012
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
K120132 · DXN
Philips Medical Systems
Cardiovascular · 28d
Cleared Feb 10, 2012
KINGYIELD WRIST BLOOD PRESSURE MONITOR
K112042 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 207d
Cleared Feb 09, 2012
AFX INTRODUCER SYSTEM
K120212 · DYB
Endologix, Inc.
Cardiovascular · 16d
Cleared Feb 09, 2012
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
K113183 · MWI
Shanghai 3f Electronics Co, Ltd.
Cardiovascular · 104d
Cleared Feb 09, 2012
SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
K112407 · DYB
Smiths Medical MD, Inc.
Cardiovascular · 171d
Cleared Feb 08, 2012
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K120178 · DQY
Reflow Medical
Cardiovascular · 19d
Cleared Feb 08, 2012
IM BAND
K113600 · DXC
Synexmed(Shenzhen)Company Limited
Cardiovascular · 65d
Cleared Feb 07, 2012
TLINK DATA MANAGEMENT SYSTEM (DMS)
K113214 · DXJ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 99d
Cleared Feb 07, 2012
Z FLEX-270TM STEERABLE SHEATH
K112541 · DRA
Great Batch Medical
Cardiovascular · 159d
Cleared Feb 06, 2012
ZIO PATCH
K113862 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 38d
Cleared Feb 06, 2012
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
K113716 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 49d
Cleared Feb 06, 2012
PATIENT MONITOR
K113653 · MHX
Edan Instruments, Inc.
Cardiovascular · 56d
Cleared Feb 06, 2012
VASCULAR SONO
K113196 · DYB
PAJUNK GmbH Medizintechnologie
Cardiovascular · 98d
Cleared Feb 03, 2012
MANTARAY CATHETER
K120129 · DQY
Bridgepoint Medical
Cardiovascular · 17d
Cleared Feb 02, 2012
HERO GRAFT
K120006 · DSY
Hemosphere, Inc.
Cardiovascular · 30d
Cleared Feb 02, 2012
MINI-MEDIC
K113165 · MWI
Athena Gtx
Cardiovascular · 99d
Cleared Feb 02, 2012
RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
K110051 · DYB
Great Batch Medical
Cardiovascular · 391d
Cleared Feb 01, 2012
PATIENT MONITOR
K113623 · MHX
Edan Instruments, Inc.
Cardiovascular · 58d
Cleared Feb 01, 2012
CONNEXALL SUITE OF SOFTWARE PRODUCTS
K112650 · MSX
Connexall USA, Inc.
Cardiovascular · 142d
Cleared Jan 31, 2012
TRANSTEK BLOOD PRESSURE MONITOR
K120058 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 22d
Cleared Jan 31, 2012
ACTIVECARE DVT ACTIVECARE+SFT
K113525 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 63d