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
5065–5088 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 26, 2011
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
K111388 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 70d
Cleared Jul 26, 2011
PATCH, PLEDGET AND INTRACARDIAC
K111187 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Jul 25, 2011
CXI TRIFORCE
K111263 · KRA
Cook Incorporated
Cardiovascular · 82d
Cleared Jul 22, 2011
CARDIAC TRIGGER MONITOR
K110987 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 105d
Cleared Jul 21, 2011
EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K111750 · DQY
Angioslide, Ltd.
Cardiovascular · 29d
Cleared Jul 20, 2011
PATIENT MONITOR
K110922 · MHX
Edan Instruments, Inc.
Cardiovascular · 110d
Cleared Jul 19, 2011
NEURON MAX SYSTEM
K111380 · DQY
Penumbra, Inc.
Cardiovascular · 64d
Cleared Jul 19, 2011
MEDLINE VESSEL CANNULA
K111147 · DWF
Medline Industries, Inc.
Cardiovascular · 85d
Cleared Jul 15, 2011
THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
K111417 · DYB
Access Scientific, Inc.
Cardiovascular · 56d
Cleared Jul 15, 2011
ACG-8511 PORTABLE ECG MONITOR
K110328 · DPS
Andon Health Co, Ltd.
Cardiovascular · 162d
Cleared Jul 14, 2011
PERCUPRO MESSENGER BALLOON CATHETER
K094048 · DYG
Cardiosolutions, Inc.
Cardiovascular · 560d
Cleared Jul 13, 2011
VACCESS PTA DILATATION CATHETER
K111850 · DQY
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Jul 13, 2011
MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR
K111652 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 30d
Cleared Jul 13, 2011
ECG PEN
K103077 · DPS
Meridian Dynamics Biomedical, Inc.
Cardiovascular · 268d
Cleared Jul 12, 2011
ENDOLOGIX AFX INTRODUCER SYSTEM
K111747 · DYB
Endologix, Inc.
Cardiovascular · 20d
Cleared Jul 08, 2011
HERO
K111601 · DPS
Medical Predictive Science Corp.
Cardiovascular · 30d
Cleared Jul 07, 2011
FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM
K110044 · DXN
Foracare, Inc.
Cardiovascular · 182d
Cleared Jul 06, 2011
MODIFIED CONCENTRIC MICROCATHETER
K111619 · DQO
Concentric Medical, Inc.
Cardiovascular · 26d
Cleared Jul 05, 2011
ASCOM MOBILE MONITORING GATEWAY (MMG)
K111215 · MSX
Ascom (Sweden) AB
Cardiovascular · 64d
Cleared Jul 05, 2011
WIRELESS MONITORING SYSTEM
K110809 · DRG
Carefusion 303, Inc.
Cardiovascular · 104d
Cleared Jul 01, 2011
MERIT MARQUIS FLOW SWITCH
K110643 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 119d
Cleared Jul 01, 2011
ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
K102648 · MAV
Shenzhen Ant Hi-Tech Industrial Co.,...
Cardiovascular · 290d
Cleared Jun 30, 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
K111498 · DQX
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 30, 2011
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
K111488 · DQX
Bridgepoint Medical
Cardiovascular · 30d