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
7081–7104 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 09, 2006
CG-7000DX-BT ECG RECORDER/TRANSMITTER
K052556 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 115d
Cleared Jan 06, 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED...
K052964 · DSY
Boston Scientific Corp
Cardiovascular · 77d
Cleared Jan 05, 2006
TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM
K053209 · DXN
Suntech Medical, Inc.
Cardiovascular · 50d
Cleared Jan 05, 2006
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
K051847 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 182d
Cleared Jan 04, 2006
ECHELON MICRO CATHETER
K051990 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 166d
Cleared Jan 04, 2006
RIO ASPIRATION CATHETER
K051880 · QEZ
Boston Scientific Corp
Cardiovascular · 177d
Cleared Jan 03, 2006
POWERHEART ECD
K052316 · MKJ
Cardiac Science, Inc.
Cardiovascular · 131d
Cleared Jan 03, 2006
TESLAGUARD, MODEL EFT G04
K052119 · MWI
Mammendorfer Institute For Physics &...
Cardiovascular · 152d
Cleared Dec 30, 2005
AMPLATZER SIZING BALLOON II
K053440 · MJN
Aga Medical Corp.
Cardiovascular · 21d
Cleared Dec 30, 2005
EKOS MICRO-INFUSION SYSTEM
K053432 · QEY
Ekos Corp.
Cardiovascular · 21d
Cleared Dec 30, 2005
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
K053304 · DXN
Cardiocom, LLC
Cardiovascular · 32d
Cleared Dec 30, 2005
CARDIOCOM COMMANDER III
K053303 · DXN
Cardiocom, LLC
Cardiovascular · 32d
Cleared Dec 30, 2005
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
K053016 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 65d
Cleared Dec 29, 2005
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
K052972 · MSX
Ge Healthcare
Cardiovascular · 66d
Cleared Dec 27, 2005
FETALGARD LITE-NIBP, MODEL FGL-NIBP
K051903 · DXN
Analogic Corporation
Cardiovascular · 167d
Cleared Dec 23, 2005
BP PRO BLOOD PRESSURE MONITOR
K053395 · DXN
Card Guard Scientific Survival , Ltd.
Cardiovascular · 17d
Cleared Dec 23, 2005
HEART STG SYSTEM AND SOFTWARE
K052283 · DQD
Stethographics, Inc.
Cardiovascular · 123d
Cleared Dec 22, 2005
MEDILOG DARWIN HOLTER ANALYSIS
K053369 · DQK
Huntleigh Healthcare
Cardiovascular · 17d
Cleared Dec 22, 2005
HOSPIRA CATH LAB CONVENIENCE KITS
K052865 · DQO
Icu Medical, Inc.
Cardiovascular · 72d
Cleared Dec 22, 2005
LIFEPAK, MODEL 1000
K042404 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 475d
Cleared Dec 20, 2005
VITALOGIK
K052288 · DSI
Mennen Medical , Ltd.
Cardiovascular · 119d
Cleared Dec 16, 2005
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
K053118 · DQY
Boston Scientific Corp
Cardiovascular · 39d
Cleared Dec 16, 2005
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
K053116 · DQY
Boston Scientific Corp
Cardiovascular · 39d
Cleared Dec 16, 2005
C2000 AUTOMATED MANIFOLD KIT
K052744 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 77d