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
4369–4392 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 24, 2013
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM
K122826 · DQY
Volcano Corporation
Cardiovascular · 222d
Cleared Apr 23, 2013
PASSEO-35
K130161 · LIT
Biotronik, Inc.
Cardiovascular · 90d
Cleared Apr 22, 2013
STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
K123539 · DXN
Stayhealthy, Inc.
Cardiovascular · 157d
Cleared Apr 22, 2013
NEXFIN MODEL 2
K122381 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 259d
Cleared Apr 22, 2013
NEXXIS OR
K122167 · DXJ
Barco N.V.
Cardiovascular · 273d
Cleared Apr 22, 2013
XHIBIT CENTRAL STATION, MODEL 96102
K122146 · MHX
Spacelabs Healthcare
Cardiovascular · 277d
Cleared Apr 18, 2013
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
K124049 · DPT
Spectralmd, Inc.
Cardiovascular · 108d
Cleared Apr 18, 2013
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
K123900 · MHX
Philips Medical Systems
Cardiovascular · 121d
Cleared Apr 18, 2013
RHYTHMIA MAPPING CATHETER
K122461 · DRF
Rhythmia Medical, Inc.
Cardiovascular · 248d
Cleared Apr 17, 2013
TRUECPR COACHING DEVICE
K123597 · LIX
Physio-Control, Inc.
Cardiovascular · 147d
Cleared Apr 17, 2013
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
K123083 · DWJ
Covidien
Cardiovascular · 198d
Cleared Apr 15, 2013
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
K123621 · OBJ
Boston Scientific Corp
Cardiovascular · 143d
Cleared Apr 15, 2013
PERSONAL HEALTH CENTER (PHC)
K122076 · DXN
Adflow Health Networks, Inc.
Cardiovascular · 273d
Cleared Apr 12, 2013
APTUS HELI-FX AORTIC SECUREMENT SYSTEM
K130677 · OTD
Aptus Endosystems, Inc.
Cardiovascular · 30d
Cleared Apr 12, 2013
MICROSLIDER TEARAWAY INTRODUCER SET
K123430 · DYB
Galt Medical Corp.
Cardiovascular · 156d
Cleared Apr 11, 2013
INFINITY CENTRALSTATION WITH INFINITY M300
K130711 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 27d
Cleared Apr 11, 2013
PATIENT MONITOR
K130056 · MWI
Ld Technology, LLC
Cardiovascular · 92d
Cleared Apr 11, 2013
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K123700 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 129d
Cleared Apr 10, 2013
JETSTREAM XC 2.4/3.4 SYSTEM
K130637 · MCW
Medrad, Inc.
Cardiovascular · 30d
Cleared Apr 09, 2013
DEVON CIRONA 6100 DVT
K130571 · JOW
Devon Medical, Inc.
Cardiovascular · 36d
Cleared Apr 09, 2013
GORE ACUSEAL VASCULAR GRAFT
K130215 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 70d
Cleared Apr 09, 2013
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
K123996 · DXQ
Ge Medical Systems Information...
Cardiovascular · 104d
Cleared Apr 09, 2013
PSA SERIES
K123916 · DTE
Osypka Medical, Inc.
Cardiovascular · 111d
Cleared Apr 09, 2013
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE...
K123153 · DQY
Medtronic, Ireland
Cardiovascular · 182d