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
5761–5784 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 30, 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
K092161 · DXN
Health & Life Co., Ltd.
Cardiovascular · 76d
Cleared Sep 25, 2009
DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
K092683 · DXN
Shanghai Little Doctor Co. Limited
Cardiovascular · 24d
Cleared Sep 25, 2009
HI-TORQUE PROGRESS GUIDE WIRE FAMILY
K091825 · DQX
Abbott Vascular, Inc.
Cardiovascular · 98d
Cleared Sep 25, 2009
CONDUCTOR CORONARY GUIDEWIRE
K090193 · DQX
Concert Medical, LLC
Cardiovascular · 241d
Cleared Sep 24, 2009
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000
K090932 · QEW
Nexgen Medical Systems, Inc.
Cardiovascular · 175d
Cleared Sep 23, 2009
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING...
K092680 · MHX
GE Healthcare Finland Oy
Cardiovascular · 22d
Cleared Sep 23, 2009
MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
K091972 · DQD
Stethoscope Technologies, Inc.
Cardiovascular · 84d
Cleared Sep 23, 2009
ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
K090989 · MKJ
Zoll Medical Corp
Cardiovascular · 169d
Cleared Sep 22, 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315
K092495 · MJN
Ev3 Neurovascular
Cardiovascular · 39d
Cleared Sep 21, 2009
BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER...
K091553 · DXN
Ningbo Diaier Electronic Co., Ltd.
Cardiovascular · 117d
Cleared Sep 21, 2009
HEALTHANYWHERE SYSTEM
K091220 · DRG
Healthanywhere, an Igeacare System...
Cardiovascular · 147d
Cleared Sep 18, 2009
DIGITAL BLOOD PRESSURE MONITOR
K092719 · DXN
Shanghai Little Doctor Electronic...
Cardiovascular · 15d
Cleared Sep 18, 2009
MARKSMANN CATHETER
K091559 · KRA
Chestnut Medical Technologies, Inc.
Cardiovascular · 113d
Cleared Sep 18, 2009
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
K091268 · DQE
Hospira, Inc.
Cardiovascular · 141d
Cleared Sep 18, 2009
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
K090450 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 210d
Cleared Sep 18, 2009
MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
K090449 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 210d
Cleared Sep 15, 2009
BELTBEAT WF-400
K083715 · DPS
Bonus Communicaciones Srl
Cardiovascular · 274d
Cleared Sep 11, 2009
HEARTRAIL III GUIDING CATHETER
K092372 · DQO
Terumo Corp.
Cardiovascular · 37d
Cleared Sep 10, 2009
ALCATEL-LUCENT TELEHEATH MANAGER
K092635 · DRG
Alcatel-Lucent Canada, Inc.
Cardiovascular · 14d
Cleared Sep 10, 2009
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
K091943 · MKJ
Cardiac Science Corporation
Cardiovascular · 72d
Cleared Sep 10, 2009
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
K091808 · DXX
Hansen Medical, Inc.
Cardiovascular · 84d
Cleared Sep 04, 2009
GEM HEART ONE/ONE+
K092576 · DPS
Gem-Med S.L.
Cardiovascular · 14d
Cleared Sep 04, 2009
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
K092455 · LIT
Boston Scientific Corporation
Cardiovascular · 25d
Cleared Sep 04, 2009
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
K092396 · DQY
Spectranetics Corp.
Cardiovascular · 30d