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
8041–8064 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 09, 2003
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A
K030561 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 77d
Cleared May 09, 2003
C3 PATIENT MONITOR
K030931 · MHX
Analogic Corp.
Cardiovascular · 45d
Cleared May 06, 2003
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
K023759 · DQD
Sonomedica
Cardiovascular · 179d
Cleared May 06, 2003
EK-PRO ARRHYTHMIA DETECTION ALGORITHM
K031320 · MHX
Ge Medical Systems Information...
Cardiovascular · 11d
Cleared May 02, 2003
CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION
K023286 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 212d
Cleared May 02, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030026 · NLH
Alliance Medical Corp.
Cardiovascular · 119d
Cleared May 02, 2003
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
K031223 · DTZ
Dideco S.P.A.
Cardiovascular · 14d
Cleared Apr 29, 2003
CARBODISSECTING ENDOSCOPE
K020925 · DWX
Endo Surgical Devices, Inc.
Cardiovascular · 404d
Cleared Apr 29, 2003
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
K021174 · DSB
Imagyn Surgical
Cardiovascular · 382d
Cleared Apr 24, 2003
ELOX P 45-BP
K023205 · DTB
Biotronik, Inc.
Cardiovascular · 211d
Cleared Apr 24, 2003
HL888JF
K030541 · DXN
Health & Life Co., Ltd.
Cardiovascular · 63d
Cleared Apr 24, 2003
SAFFRON NM GUIDING CATHETER
K030715 · DQY
Neich Medical (Shenzhen) Company Limited
Cardiovascular · 48d
Cleared Apr 24, 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
K030779 · DQY
Medtronic Vascular
Cardiovascular · 44d
Cleared Apr 24, 2003
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14,...
K030984 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 27d
Cleared Apr 24, 2003
EDWARDS INTRODUCER SHEATH
K031087 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 17d
Cleared Apr 23, 2003
VTI 20 MHZ GATED DOPPLER
K031091 · DPW
Vascular Technology Incorporated
Cardiovascular · 16d
Cleared Apr 22, 2003
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K030129 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 98d
Cleared Apr 22, 2003
STEELEX ELECTRODE SET
K030556 · LDF
Aesculap, Inc.
Cardiovascular · 60d
Cleared Apr 18, 2003
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
K021421 · DRF
Tz Medical, Inc.
Cardiovascular · 350d
Cleared Apr 18, 2003
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
K030231 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Apr 17, 2003
HL888HM
K030499 · DXN
Health & Life Co., Ltd.
Cardiovascular · 57d
Cleared Apr 17, 2003
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
K030613 · MHX
Criticare Systems, Inc.
Cardiovascular · 50d
Cleared Apr 11, 2003
GOLDWAY PATIENT MONITOR, MODEL # UT4000F
K021154 · MWI
Goldway Us, Inc.
Cardiovascular · 366d
Cleared Apr 11, 2003
HL888HA
K030498 · DXN
Health & Life Co., Ltd.
Cardiovascular · 51d