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
8497–8520 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 14, 2002
SMARTFLOW PULSE TRANSMISSION COEFFICIENT
K020127 · DQK
Florence Medical , Ltd.
Cardiovascular · 30d
Cleared Feb 13, 2002
FLOWGUARD DEVICE
K013803 · DPW
Biosonix , Ltd.
Cardiovascular · 90d
Cleared Feb 12, 2002
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452 · DPW
Koven Technology, Inc.
Cardiovascular · 362d
Cleared Feb 12, 2002
COBE REVOLUTION
K011835 · KFM
Cobe Cardiovascular, Inc.
Cardiovascular · 245d
Cleared Feb 12, 2002
REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
K012675 · JOW
Adven Medical
Cardiovascular · 182d
Cleared Feb 12, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
K014261 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 47d
Cleared Feb 11, 2002
INCLUDER CLAMP
K010694 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 340d
Cleared Feb 11, 2002
SOLAR 8000M SYSTEM
K012467 · DSI
General Electric Medical Systems...
Cardiovascular · 194d
Cleared Feb 11, 2002
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · JOW
Sterilmed, Inc.
Cardiovascular · 185d
Cleared Feb 11, 2002
LUMEND FRONTRUNNER CTO CORONARY CATHETER
K013284 · DQY
Lumend, Inc.
Cardiovascular · 132d
Cleared Feb 11, 2002
TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH)
K013635 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 98d
Cleared Feb 11, 2002
JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
K013944 · DWF
Jostra AG
Cardiovascular · 74d
Cleared Feb 11, 2002
MODIFICATION TO TRANSSEPTAL INTRODUCER SET
K020090 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 32d
Cleared Feb 11, 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · DQX
Boston Scientific Corp
Cardiovascular · 14d
Cleared Feb 07, 2002
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
K002604 · DSI
Invivo Research, Inc.
Cardiovascular · 534d
Cleared Feb 07, 2002
TASK FORCE MONITOR 3040
K014063 · DSB
Cnsystems Medizintechnik GmbH
Cardiovascular · 58d
Cleared Feb 06, 2002
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
K011540 · MHX
Datascope Corp.
Cardiovascular · 264d
Cleared Feb 06, 2002
CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW...
K012601 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH...
K012606 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE
K012612 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS
K012616 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
K012621 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
K013717 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 90d
Cleared Feb 06, 2002
FUKUDA DENSHI DYNASCOPE MODEL DS-5700
K020084 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 27d