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
6553–6576 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 14, 2007
PTFE FLIXENE GRADUATED WALL GRAFT
K071923 · DSY
Atrium Medical Corp.
Cardiovascular · 33d
Cleared Aug 13, 2007
TESLA NIBP
K062974 · DXN
Mammendorfer Institut Fur Physik Und...
Cardiovascular · 318d
Cleared Aug 10, 2007
PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS
K072070 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 11d
Cleared Aug 10, 2007
ENDOWAVE INFUSION SYSTEM
K071933 · QEY
Ekos Corp.
Cardiovascular · 28d
Cleared Aug 10, 2007
XTRACT CATHETER SYSTEM
K071529 · QEZ
Lumen Biomedical, Inc.
Cardiovascular · 66d
Cleared Aug 10, 2007
MEMO 3D SEMIRIGID ANNULOPLASTY RING
K071327 · KRH
Sorin Biomedica Cardio S.R.L.
Cardiovascular · 91d
Cleared Aug 08, 2007
RTX3370
K071953 · DRG
Rtx Healthcare A/S
Cardiovascular · 23d
Cleared Aug 08, 2007
FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR
K070209 · DXN
Fego Precision Industrial Co;, Ltd.
Cardiovascular · 198d
Cleared Aug 06, 2007
EKOS MICRO-INFUSION SYSTEM
K063620 · QEY
Ekos Corp.
Cardiovascular · 244d
Cleared Aug 03, 2007
MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05
K071960 · DXN
Meditech Kft.
Cardiovascular · 18d
Cleared Aug 03, 2007
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
K071341 · DWJ
Medivance, Inc.
Cardiovascular · 81d
Cleared Aug 03, 2007
UNIRING - ANNULOPLASTY RING WITH SIZERS
K071281 · KRH
Peters Surgical
Cardiovascular · 88d
Cleared Jul 31, 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071514 · QEZ
Possis Medical, Inc.
Cardiovascular · 57d
Cleared Jul 31, 2007
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552,...
K071342 · QEZ
Possis Medical, Inc.
Cardiovascular · 78d
Cleared Jul 31, 2007
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
K071214 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 91d
Cleared Jul 26, 2007
NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
K071819 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 23d
Cleared Jul 24, 2007
DL900 SERIES HOLTER RECORDER
K071733 · MWJ
Braemar, Inc.
Cardiovascular · 28d
Cleared Jul 23, 2007
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
K071572 · DTZ
Terumo Corp.
Cardiovascular · 45d
Cleared Jul 18, 2007
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
K071665 · DQY
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jul 16, 2007
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
K071494 · DTZ
Terumo Corp.
Cardiovascular · 47d
Cleared Jul 16, 2007
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
K070500 · DSB
Ni Medical
Cardiovascular · 145d
Cleared Jul 13, 2007
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
K071721 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 18d
Cleared Jul 13, 2007
TRELLIS-6 PERIPHERAL INFUSION SYSTEM
K071664 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 25d
Cleared Jul 13, 2007
BLUE MAX BALLOON DILATATION CATHETER
K071309 · LIT
Boston Scientific Corp
Cardiovascular · 65d