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
4825–4848 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 12, 2012
WILDCAT CATHETER
K113838 · PDU
Avinger, Inc.
Cardiovascular · 75d
Cleared Mar 09, 2012
MODIFIED CONCENTIRC MICROCATHETER
K113260 · DQO
Concentric Medical, Inc.
Cardiovascular · 126d
Cleared Mar 07, 2012
NUVANT, MOBILC CARDIAC TELEMETRY
K113372 · QYX
Corventis, Inc.
Cardiovascular · 112d
Cleared Mar 06, 2012
NC TREK OTW CORONARY DILATATION CATHETER
K113464 · LOX
Abbott Vascular
Cardiovascular · 105d
Cleared Mar 02, 2012
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584 · DXO
St Jude Medical
Cardiovascular · 88d
Cleared Mar 02, 2012
ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
K113264 · DXN
Ld Technology, LLC
Cardiovascular · 119d
Cleared Mar 02, 2012
GLIDER PTCA BALLOON CATHETER
K111544 · LOX
Trireme Medical, Inc.
Cardiovascular · 273d
Cleared Mar 01, 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR
K113238 · DXN
Health & Life Co., Ltd.
Cardiovascular · 120d
Cleared Feb 28, 2012
E-PASS
K113148 · DTL
Synexmed(Shenzhen)Company Limited
Cardiovascular · 127d
Cleared Feb 24, 2012
Q50 PLUS STENT GRAFT BALLOON CATHETER
K120381 · DQY
Qxmedical, LLC
Cardiovascular · 17d
Cleared Feb 24, 2012
CONNEX WORKSTATION
K120343 · MWI
Welch Allyn, Inc.
Cardiovascular · 21d
Cleared Feb 24, 2012
MEDIGUIDE TECHNOLOGY
K120301 · DQK
St. Jude Medical, Mediguide...
Cardiovascular · 24d
Cleared Feb 24, 2012
JETSTREAM NAVITUS L SYSTEM
K120242 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 28d
Cleared Feb 24, 2012
ENVOY DISTAL ACCESS GUIDING CATHETER
K120229 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 30d
Cleared Feb 24, 2012
14 WIRE STANDARD, 14 WIRE LS
K113454 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 95d
Cleared Feb 24, 2012
BLOOD PRESSURE MONITOR
K112691 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 162d
Cleared Feb 24, 2012
BLOOD PRESSURE MONITOR
K112690 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 162d
Cleared Feb 23, 2012
SUREFIRE GUIDE SHEATH
K113737 · DQO
Surefire Medical, Inc.
Cardiovascular · 65d
Cleared Feb 23, 2012
UPSTREAM SUPPORT CATHETER
K112886 · DQY
Upstream Peripheral Technologies
Cardiovascular · 146d
Cleared Feb 22, 2012
ASPIRE MAX ASPIRATION CATHETER
K113757 · QEZ
Control Medical Technology, LLC
Cardiovascular · 63d
Cleared Feb 22, 2012
SMARTHEART
K113514 · DXH
Shl Telemedicine International , Ltd.
Cardiovascular · 86d
Cleared Feb 21, 2012
BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR
K111141 · DXN
Wenzhou Bokang Instruments Co., Ltd.
Cardiovascular · 305d
Cleared Feb 17, 2012
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
K120081 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 37d
Cleared Feb 17, 2012
EQUIVITAL
K113054 · MHX
Hidalgo Limited
Cardiovascular · 127d