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
7777–7800 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 18, 2003
MODIFICATION TO UNITY NETWORK ID
K033672 · MWI
Ge Medical Systems Information...
Cardiovascular · 24d
Cleared Dec 16, 2003
THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
K032920 · DXT
Coeur Medical
Cardiovascular · 85d
Cleared Dec 16, 2003
CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
K033793 · MCW
Rex Medical
Cardiovascular · 11d
Cleared Dec 12, 2003
PROGREAT
K033583 · DQO
Terumo Medical Corp.
Cardiovascular · 29d
Cleared Dec 11, 2003
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER,...
K033424 · DPW
Transonic Systems, Inc.
Cardiovascular · 49d
Cleared Dec 11, 2003
INFINITY GAMMAXL
K033600 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 27d
Cleared Dec 11, 2003
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 21d
Cleared Dec 11, 2003
M2376A PHILIPS DEVICE LINK SYSTEM
K033680 · MWI
Philips Medical Systems
Cardiovascular · 17d
Cleared Dec 11, 2003
GLIDESHEATH
K033681 · DYB
Terumo Corp.
Cardiovascular · 17d
Cleared Dec 11, 2003
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K033708 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 15d
Cleared Dec 11, 2003
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE...
K033714 · DTN
Dideco S.P.A.
Cardiovascular · 15d
Cleared Dec 10, 2003
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
K031949 · DXF
Baylis Medical Co., Inc.
Cardiovascular · 169d
Cleared Dec 10, 2003
MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
K032841 · DPT
Moor Instruments, Ltd.
Cardiovascular · 90d
Cleared Dec 10, 2003
TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700
K033025 · DXN
Tytan Medical Corp.
Cardiovascular · 75d
Cleared Dec 09, 2003
CD LEYCOM PRESSURE/VOLUME CATHETERS
K031599 · DQO
Cd Leycom BV
Cardiovascular · 202d
Cleared Dec 08, 2003
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K033613 · DTA
Biotronik, Inc.
Cardiovascular · 21d
Cleared Dec 05, 2003
MIDA ALGORITHM REV. B
K023414 · DYC
Ortivus AB
Cardiovascular · 420d
Cleared Dec 05, 2003
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B),...
K032810 · KRH
Medtronic Heart Valves
Cardiovascular · 87d
Cleared Dec 05, 2003
HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
K032821 · NPP
Hygia Health Services, Inc.
Cardiovascular · 91d
Cleared Dec 05, 2003
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
K033542 · DQX
Galt Medical Corp.
Cardiovascular · 25d
Cleared Dec 04, 2003
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
K031124 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 240d
Cleared Dec 04, 2003
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED...
K032900 · DSY
Edwards Lifesciences, LLC
Cardiovascular · 78d
Cleared Nov 26, 2003
RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
K032230 · DQD
Thinklabs, Inc.
Cardiovascular · 128d
Cleared Nov 26, 2003
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
K033281 · MSX
Datex-Ohmeda
Cardiovascular · 43d