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
6049–6072 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 12, 2009
VITAL SIGNS MONITOR, MODEL: MD500B
K082787 · MWI
Beijing Choice Electronic Technololgy...
Cardiovascular · 111d
Cleared Jan 12, 2009
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
K082746 · DSP
Insightra Medical, Inc.
Cardiovascular · 115d
Cleared Jan 09, 2009
CONFIDANT, MODEL 2.6
K083331 · DRG
Confidant, Inc.
Cardiovascular · 58d
Cleared Jan 07, 2009
CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE
K081924 · DXN
Calhealth, Inc.
Cardiovascular · 184d
Cleared Jan 07, 2009
REFLEXION HD HIGH-DENSITY MAPPING CATHETER
K080179 · DRF
St Jude Medical
Cardiovascular · 349d
Cleared Jan 06, 2009
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
K081258 · DRF
Biosense Webster, Inc.
Cardiovascular · 249d
Cleared Dec 30, 2008
MERIT MICROCATHETER
K082613 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 113d
Cleared Dec 30, 2008
NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021
K082203 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 147d
Cleared Dec 29, 2008
MORTARA ELI 350 ELECTROCARDIOGRAPH
K082946 · DPS
Mortara Instrument, Inc.
Cardiovascular · 88d
Cleared Dec 29, 2008
VICOR PD2I ANALYZER, VERSION 2.1
K082709 · DPS
Vicor Technologies, Inc.
Cardiovascular · 104d
Cleared Dec 24, 2008
CONQUEST PTA BALLOON DILATATION CATHETER
K083657 · DQY
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Dec 24, 2008
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
K083347 · DRL
Fluke Biomedical
Cardiovascular · 41d
Cleared Dec 24, 2008
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001...
K083271 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 48d
Cleared Dec 24, 2008
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
K083091 · KRD
Biocompatibles UK Limited
Cardiovascular · 68d
Cleared Dec 19, 2008
VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
K082630 · DXQ
Zefon Intl.
Cardiovascular · 100d
Cleared Dec 18, 2008
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE...
K083301 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 38d
Cleared Dec 17, 2008
HEARTSUITE HEMODYNAMICS 7.10
K082421 · DQK
Emageon, Inc.
Cardiovascular · 117d
Cleared Dec 17, 2008
STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
K082344 · DWF
Sorin Group Deutschland GmbH
Cardiovascular · 124d
Cleared Dec 17, 2008
BARD PTFE (TEFLON) COATED GUIDE WIRES
K082094 · DQX
C.R. Bard Inc., Bard...
Cardiovascular · 146d
Cleared Dec 17, 2008
TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
K081498 · DXN
Biocomfort Diagnostics GmbH & Co. KG
Cardiovascular · 202d
Cleared Dec 15, 2008
HEARTRAK SMART ECAT
K083535 · DXH
Universal Medical, Inc.
Cardiovascular · 17d
Cleared Dec 15, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
K083402 · DYB
St Jude Medical
Cardiovascular · 27d
Cleared Dec 15, 2008
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
K083335 · QEY
Omnisonics Medical Technologies
Cardiovascular · 33d
Cleared Dec 15, 2008
CHEETAH RELIANT
K083093 · DSB
Cheetah Medical, Inc.
Cardiovascular · 59d