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
5329–5352 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 19, 2010
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
K103057 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 35d
Cleared Nov 19, 2010
CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
K102147 · DWC
Cardioquip Llp
Cardiovascular · 112d
Cleared Nov 18, 2010
MOORVMS-PRES PRESSURE CUFF CONTROLLER
K102433 · DPW
Moor Instruments, Ltd.
Cardiovascular · 84d
Cleared Nov 18, 2010
CRITICOOL PRO
K102112 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 113d
Cleared Nov 17, 2010
CONCENTRIC BALLOON GUIDE CATHETER
K102657 · DQY
Concentric Medical, Inc.
Cardiovascular · 63d
Cleared Nov 16, 2010
PTFE PORTABLE INTRODUCER
K102540 · DYB
Great Batch Medical
Cardiovascular · 74d
Cleared Nov 16, 2010
MINIATURIZE CHEST COMPRESSOR (MCC)
K102068 · DRM
Resuscitation International
Cardiovascular · 116d
Cleared Nov 16, 2010
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL...
K100565 · MKJ
Bio-Detek, Inc.
Cardiovascular · 260d
Cleared Nov 12, 2010
WELCH ALLYN 1500 PATIENT MONITOR
K101619 · MHX
Schiller AG
Cardiovascular · 156d
Cleared Nov 12, 2010
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS...
K101174 · OCL
AtriCure, Inc.
Cardiovascular · 199d
Cleared Nov 09, 2010
ELECTRONIC BLOOD PRESURE MONITOR
K102988 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 34d
Cleared Nov 09, 2010
SEQURE SNARE SYSTEM
K102484 · MMX
Lifetech Scientific (Shenzhen) Co., Ltd.
Cardiovascular · 71d
Cleared Nov 09, 2010
ATRAUMATIC VASCULAR CLAMPS
K102048 · DXC
Geomed Medizin-Technik GmbH & Co. KG
Cardiovascular · 111d
Cleared Nov 05, 2010
LIFENET SYSTEM
K102757 · MSX
Physio-Control, Inc.
Cardiovascular · 43d
Cleared Nov 04, 2010
KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102631 · DXN
Andon Health Co, Ltd.
Cardiovascular · 52d
Cleared Nov 03, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102930 · DXN
Andon Health Co, Ltd.
Cardiovascular · 30d
Cleared Oct 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102906 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Oct 29, 2010
GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)
K102905 · DQK
Mediguide, Ltd.
Cardiovascular · 29d
Cleared Oct 29, 2010
WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F,...
K101035 · JOW
Wmi Enterprises, LLC
Cardiovascular · 198d
Cleared Oct 29, 2010
REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS
K092896 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 403d
Cleared Oct 28, 2010
NEXFIN MODEL 2
K101123 · DXN
Bmeye B.V.
Cardiovascular · 189d
Cleared Oct 26, 2010
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC...
K102420 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 62d
Cleared Oct 26, 2010
XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
K101571 · MWI
Witt Biomedical Corp
Cardiovascular · 144d
Cleared Oct 26, 2010
AUGEASE VASCULAR AUGMENTATION DEVICE
K101355 · JOW
Augdvt, LLC
Cardiovascular · 165d