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
6721–6744 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 29, 2006
MODIFICATION TO HEALTH BUDDY APPLIANCE
K063612 · DRG
Health Hero Network, Inc.
Cardiovascular · 25d
Cleared Dec 22, 2006
PATIENT DATA HANDLER & DEVICES (PDH&D)
K063484 · DRG
Intermed Advisors, Inc.
Cardiovascular · 35d
Cleared Dec 22, 2006
LIFEPAK 20 DEFIBRILLATOR/ MONITOR
K063119 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 71d
Cleared Dec 21, 2006
AUTOPULSE RESUSCITATION SYSTEM MODEL100
K063602 · DRM
Zoll Circulation
Cardiovascular · 17d
Cleared Dec 21, 2006
CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM
K063547 · MWI
Witt Biomedical Corp
Cardiovascular · 27d
Cleared Dec 21, 2006
ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX
K063182 · DYB
Enpath Medical, Inc.
Cardiovascular · 63d
Cleared Dec 21, 2006
VS-800 VITAL SIGNS MONITOR
K063055 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 77d
Cleared Dec 20, 2006
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619 · KRD
Cook, Inc.
Cardiovascular · 15d
Cleared Dec 15, 2006
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
K062577 · DSA
Tz Medical, Inc.
Cardiovascular · 106d
Cleared Dec 15, 2006
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
K061680 · DQY
Atrium Medical Corp.
Cardiovascular · 183d
Cleared Dec 14, 2006
PRONTO V3 EXTRACTION CATHETER, MODEL 5003
K063371 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 36d
Cleared Dec 14, 2006
SUPRACOR BALLOON CATHETER
K062582 · DSP
Abiomed, Inc.
Cardiovascular · 105d
Cleared Dec 13, 2006
ZOLL E SERIES WITH REAL CPR HELP
K062177 · MKJ
ZOLL Medical Corporation
Cardiovascular · 135d
Cleared Dec 12, 2006
VASCUTRAK PTA DILATION CATHETER
K063657 · PNO
Ymed, Inc.
Cardiovascular · 4d
Cleared Dec 12, 2006
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS...
K052465 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 460d
Cleared Dec 11, 2006
MODIFICATION TO MODEL 750 SERIES MONITOR
K063087 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 62d
Cleared Dec 11, 2006
ORI F6T DRY ECG MONITORING ELECTRODE
K062760 · DRX
Orbital Research, Inc.
Cardiovascular · 87d
Cleared Dec 08, 2006
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
K061902 · DWJ
Inditherm Medical
Cardiovascular · 156d
Cleared Dec 07, 2006
PRN THERMALCARE, MODEL 3000
K062794 · DWJ
American Healthcare Products, Inc.
Cardiovascular · 80d
Cleared Dec 07, 2006
MERCATOR MICROSYRINGE II INFUSION CATHETER
K062752 · KRA
Mercator Medsystems, Inc.
Cardiovascular · 84d
Cleared Dec 07, 2006
MODIFICATION TO: SMITHWICK CAROTID SHUNT
K061484 · DXC
Mcpherson Enterprises, Inc.
Cardiovascular · 191d
Cleared Dec 06, 2006
I-SCOPE 200
K062364 · DQD
Dongjin Medical Co., Ltd.
Cardiovascular · 114d
Cleared Dec 06, 2006
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV,...
K062324 · MHX
Ge Healthcare
Cardiovascular · 119d
Cleared Dec 06, 2006
BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM
K051817 · DXC
Cardiva Medical, Inc.
Cardiovascular · 519d