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
4609–4632 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 06, 2012
IMPELLA 2.5 PLUS CATHETER
K112892 · PBL
Abiomed, Inc.
Cardiovascular · 342d
Cleared Sep 05, 2012
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON...
K122379 · LIT
Ostial Corporation
Cardiovascular · 30d
Cleared Sep 05, 2012
MOLLRING MULTITASC
K121415 · DWX
LeMaitre Vascular, Inc.
Cardiovascular · 117d
Cleared Aug 31, 2012
TYSHAK NUCLEUS
K121859 · DQY
NuMED, Inc.
Cardiovascular · 66d
Cleared Aug 31, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K121196 · LOX
Boston Scientific Corp
Cardiovascular · 134d
Cleared Aug 31, 2012
PINTLER PATIENT WARMING SYSTEM
K113705 · DWJ
Pintler Medical
Cardiovascular · 259d
Cleared Aug 30, 2012
RUBICON 18 SUPPORT CATHETER
K122394 · DQY
Boston Scientific Corp
Cardiovascular · 23d
Cleared Aug 29, 2012
INTELLIVUE PATIENT MONITOR
K122439 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 19d
Cleared Aug 29, 2012
AZUR DETACHABLE 35
K122316 · KRD
MicroVention, Inc.
Cardiovascular · 28d
Cleared Aug 29, 2012
PADNET 2.0
K122281 · JOM
Biomedix, Inc.
Cardiovascular · 30d
Cleared Aug 29, 2012
ARTISAN EXTEND CONTROL CATHETER
K122275 · DRA
Hansen Medical
Cardiovascular · 30d
Cleared Aug 29, 2012
INTRODUCER SET, MODEL ADELANTE-S SERIES
K122084 · DYB
Oscor, Inc.
Cardiovascular · 44d
Cleared Aug 29, 2012
HEM-7200-Z (BP742)
K121932 · DXN
Omron Healthcare, Inc.
Cardiovascular · 58d
Cleared Aug 24, 2012
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
K122254 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Aug 23, 2012
AMPLATZER TORQVUE FX
K121611 · DQY
Aga Medical Corporation
Cardiovascular · 83d
Cleared Aug 23, 2012
LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
K111603 · DYB
Ep Dynamics, Inc.
Cardiovascular · 442d
Cleared Aug 22, 2012
INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
K121536 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 90d
Cleared Aug 22, 2012
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
K121185 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 126d
Cleared Aug 20, 2012
VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE)
K122179 · JOW
Compression Therapy Concepts
Cardiovascular · 28d
Cleared Aug 20, 2012
WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
K121720 · DWJ
Welkins, LLC
Cardiovascular · 69d
Cleared Aug 17, 2012
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 24d
Cleared Aug 17, 2012
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · DSY
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Aug 17, 2012
A-V FOOT PUMP
K121718 · JOW
Dalian Labtek Science & Development...
Cardiovascular · 67d
Cleared Aug 17, 2012
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH...
K121025 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 135d