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
4417–4440 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 14, 2013
CATALYST II AND III
K130124 · DXC
Cardiva Medical, Inc.
Cardiovascular · 56d
Cleared Mar 13, 2013
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K130520 · DTZ
Ashitaka Factory of Terumo Corp.
Cardiovascular · 13d
Cleared Mar 13, 2013
CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
K130493 · DTZ
Terumo Corporation
Cardiovascular · 15d
Cleared Mar 13, 2013
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR,...
K130359 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Mar 13, 2013
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
K130333 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 30d
Cleared Mar 13, 2013
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
K130280 · DTZ
Terumo Corporation
Cardiovascular · 36d
Cleared Mar 13, 2013
NUVON VITALS CHARTING SYSTEM
K130234 · MWI
Nuvon, Inc.
Cardiovascular · 42d
Cleared Mar 13, 2013
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING,...
K123370 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 132d
Cleared Mar 12, 2013
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
K130153 · MKJ
Philips Medical Systems
Cardiovascular · 49d
Cleared Mar 11, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
K123073 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 161d
Cleared Mar 11, 2013
CS-MAG II
K121825 · DPS
Biomagnetik-Park GmbH
Cardiovascular · 263d
Cleared Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
K122469 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION...
K122468 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 08, 2013
SYNOVIS COLLAGEN MATRIX (TBD)
K122306 · DXZ
Synovis Surgical Innovations
Cardiovascular · 219d
Cleared Mar 07, 2013
HERO GRAFT
K124039 · DSY
Hemoshpere, Inc., A Cryolife Company
Cardiovascular · 69d
Cleared Mar 07, 2013
SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE...
K124007 · DQX
Micro Therapeutics, Inc. D/B/A: Ev3,...
Cardiovascular · 71d
Cleared Mar 07, 2013
SAM JUNCTIONAL TOURNIQUET
K123694 · DXC
Sam Medical Products
Cardiovascular · 94d
Cleared Mar 05, 2013
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
K123837 · MTD
Biosense Webster, Inc.
Cardiovascular · 82d
Cleared Mar 05, 2013
CIMVA UNIVERSAL
K123472 · MHX
Therapeutic Monitoring Systems (Tms),...
Cardiovascular · 112d
Cleared Mar 04, 2013
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE...
K130307 · KRD
Celonova Biosciences, Inc.
Cardiovascular · 25d
Cleared Mar 04, 2013
URSA ANGIOGRAPHIC CATHETER
K123818 · DQO
Curative Medical Technology, Inc.
Cardiovascular · 82d
Cleared Mar 01, 2013
MUSE CARDIOLOGY INFORMATION SYSTEM
K130155 · DQK
Ge Medical Systems Information...
Cardiovascular · 38d
Cleared Mar 01, 2013
TRANSTEK BLOOD PRESSURE MONITOR
K123780 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 81d
Cleared Mar 01, 2013
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
K122590 · DQX
Terumo Medical Corporation
Cardiovascular · 189d