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
8161–8184 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 09, 2003
LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
K023960 · DXG
Lidco, Ltd.
Cardiovascular · 41d
Cleared Jan 08, 2003
CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
K021694 · DTQ
Cardiovention, Inc.
Cardiovascular · 231d
Cleared Jan 08, 2003
MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
K022272 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 177d
Cleared Jan 08, 2003
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
K024069 · DWF
Medtronic Vascular
Cardiovascular · 29d
Cleared Jan 07, 2003
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K023427 · DRN
Cardiomedics, Inc.
Cardiovascular · 88d
Cleared Dec 31, 2002
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
K023334 · DSA
Baylis Medical Co., Inc.
Cardiovascular · 85d
Cleared Dec 30, 2002
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024032 · DQY
Medtronic Vascular
Cardiovascular · 24d
Cleared Dec 30, 2002
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024035 · DQY
Medtronic Vascular
Cardiovascular · 24d
Cleared Dec 30, 2002
MODIFICATION TO CARDEON AEGIS CATHETER
K024058 · DWF
Cardeon Corp.
Cardiovascular · 21d
Cleared Dec 24, 2002
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
K021509 · JOW
Hygia Health Services, Inc.
Cardiovascular · 229d
Cleared Dec 24, 2002
CHEETAH I.V.D.S., MODEL 2002P
K023370 · DQK
Cheetah Medical, Inc.
Cardiovascular · 77d
Cleared Dec 24, 2002
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · DXC
Radi Medical Systems AB
Cardiovascular · 11d
Cleared Dec 18, 2002
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
K024108 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 5d
Cleared Dec 17, 2002
PROSOLV CARDIVASCULAR VIEWER
K023112 · DQK
Problem Solving Concepts, Inc.
Cardiovascular · 89d
Cleared Dec 17, 2002
JOSTRA MECC SYSTEM
K023132 · KFM
Jostra AG
Cardiovascular · 88d
Cleared Dec 17, 2002
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
K023185 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 84d
Cleared Dec 16, 2002
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000,...
K022762 · DQX
Jomed, Inc.
Cardiovascular · 118d
Cleared Dec 13, 2002
INFANT/CHILD REDUCED ENERGY ELECTRODES
K022732 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 119d
Cleared Dec 13, 2002
MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
K023938 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 17d
Cleared Dec 12, 2002
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773,...
K021682 · DXN
Omron Healthcare, Inc.
Cardiovascular · 204d
Cleared Dec 12, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K023180 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 79d
Cleared Dec 11, 2002
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · DXC
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 349d
Cleared Dec 11, 2002
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
K023803 · DTB
Biotronik, Inc.
Cardiovascular · 27d
Cleared Dec 11, 2002
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
K023880 · DWF
Ethicon, Inc.
Cardiovascular · 20d