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
6313–6336 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 08, 2008
ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER
K080360 · DQY
Endologix, Inc.
Cardiovascular · 57d
Cleared Apr 04, 2008
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
K080806 · QEZ
Possis Medical, Inc.
Cardiovascular · 14d
Cleared Apr 04, 2008
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30,...
K072583 · DTR
Maquet Cardiopulmonary, AG
Cardiovascular · 204d
Cleared Apr 03, 2008
BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202
K080789 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 14d
Cleared Apr 03, 2008
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
K080192 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 69d
Cleared Apr 02, 2008
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
K073445 · DXN
Taidoc Technology Corporation
Cardiovascular · 117d
Cleared Apr 01, 2008
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
K073434 · DYB
Bipore, Inc.
Cardiovascular · 117d
Cleared Mar 28, 2008
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
K073550 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 101d
Cleared Mar 28, 2008
QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
K073519 · QEZ
Kensey Nash Corp.
Cardiovascular · 105d
Cleared Mar 26, 2008
MODIFICATION TO: FOX PLUS PTA CATHETER
K080264 · LIT
Abbott Vascular-Vascular Solutions
Cardiovascular · 54d
Cleared Mar 25, 2008
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
K072329 · DQY
Biotronik, Inc.
Cardiovascular · 218d
Cleared Mar 24, 2008
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
K080495 · MHX
Philips Medical Systems
Cardiovascular · 31d
Cleared Mar 24, 2008
DASH 2500 PATIENT MONITOR
K080157 · MHX
Ge Medical Systems Information...
Cardiovascular · 61d
Cleared Mar 20, 2008
RUNTHROUGH NS EXTENSION WIRE
K080563 · DQX
Terumo Medical Corp.
Cardiovascular · 21d
Cleared Mar 20, 2008
ACUITY UNIVERSAL CUTTER
K080154 · DQY
Cardiac Pacemakers, Inc.
Cardiovascular · 57d
Cleared Mar 20, 2008
CLARIVEIN CATHETER
K071468 · KRA
Vascular Insights, LLC
Cardiovascular · 296d
Cleared Mar 19, 2008
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K072527 · DRM
Zoll Circulation
Cardiovascular · 194d
Cleared Mar 13, 2008
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9,...
K080500 · DYB
Acumen Medical, Inc.
Cardiovascular · 17d
Cleared Mar 13, 2008
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
K080461 · MLD
Philips Medical Systems
Cardiovascular · 22d
Cleared Mar 13, 2008
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K073324 · KRH
Medtronic, Inc.
Cardiovascular · 107d
Cleared Mar 13, 2008
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
K073260 · DTL
Device Partners International
Cardiovascular · 114d
Cleared Mar 13, 2008
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
K072864 · DRB
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 160d
Cleared Mar 11, 2008
ATRICURE COOLRAIL LINEAR PEN
K073605 · OCL
AtriCure, Inc.
Cardiovascular · 81d
Cleared Mar 07, 2008
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K080415 · DYB
Terumo Medical Corp.
Cardiovascular · 22d