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
7633–7656 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 21, 2004
ZOLL AED PLUS
K033474 · MKJ
Zoll Medical Corp
Cardiovascular · 200d
Cleared May 21, 2004
RINSPIRATION SYSTEM
K041291 · DQO
Kerberos Proximal Solutions, Inc.
Cardiovascular · 7d
Cleared May 20, 2004
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
K040829 · DSY
Vascutek, Ltd.
Cardiovascular · 50d
Cleared May 19, 2004
A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR
K040371 · DXN
A&D Engineering, Inc.
Cardiovascular · 92d
Cleared May 18, 2004
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION...
K031357 · MJN
Possis Medical, Inc.
Cardiovascular · 384d
Cleared May 18, 2004
ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT
K040013 · QEZ
Possis Medical, Inc.
Cardiovascular · 134d
Cleared May 17, 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
K040825 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 48d
Cleared May 17, 2004
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200
K041228 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 7d
Cleared May 14, 2004
ENERTRON CPR JACK
K024215 · DRM
Enertron Engineering Co.
Cardiovascular · 511d
Cleared May 14, 2004
INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA...
K033957 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 144d
Cleared May 12, 2004
VERICOR
K031327 · DXN
Cvp Diagnostics, Inc.
Cardiovascular · 383d
Cleared May 12, 2004
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL...
K040165 · DRA
St Jude Medical
Cardiovascular · 107d
Cleared May 12, 2004
MODIFICATION TO INFINITY EXPLORER
K040945 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 30d
Cleared May 12, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE...
K040955 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 29d
Cleared May 12, 2004
INFINITY GAMMA
K041087 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 16d
Cleared May 11, 2004
FOX PLUS PTA CATHETER
K040954 · LIT
Abbott Laboratories, Inc.
Cardiovascular · 28d
Cleared May 07, 2004
FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR
K032927 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 228d
Cleared May 06, 2004
INTRA-AORTIC BALLOON (IAB)
K040801 · DSP
Arrow Intl., Inc.
Cardiovascular · 38d
Cleared May 06, 2004
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
K041061 · DTM
Dideco S.P.A.
Cardiovascular · 13d
Cleared May 06, 2004
NUMED MULLINS X PTA CATHETER
K041093 · DQY
NuMED, Inc.
Cardiovascular · 9d
Cleared May 05, 2004
GORE TRI-LOBE BALLOON CATHETER
K033670 · DQY
W.L. Gore & Associates, Inc.
Cardiovascular · 163d
Cleared May 05, 2004
GREENLIGHT 300
K040410 · DXN
A C Cossor & Son (Surgical) Limited
Cardiovascular · 77d
Cleared May 04, 2004
BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR
K033216 · DXN
The Buzz Group, LLC
Cardiovascular · 214d
Cleared May 04, 2004
HEARTSTART MRX, MODEL M3535A
K040404 · MKJ
Philips Medical Systems, Inc.
Cardiovascular · 77d