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
4681–4704 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 18, 2012
ST80I STRESS TEST SYSTEM
K121638 · DQK
Philips Health Care
Cardiovascular · 44d
Cleared Jul 18, 2012
WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K121355 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 75d
Cleared Jul 18, 2012
ZIO PATCH
K121319 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 77d
Cleared Jul 18, 2012
INTELLIVUE PATIENT MONITOR
K120366 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 163d
Cleared Jul 18, 2012
CONNECTED CARE MOBILE APPLICATION
K120325 · DRG
Watermark Medical
Cardiovascular · 167d
Cleared Jul 17, 2012
NMI MICROCATHETER
K121954 · DQO
Navilyst Medical, Inc.
Cardiovascular · 14d
Cleared Jul 16, 2012
ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
K120253 · DRG
Elcam Medical Acal
Cardiovascular · 171d
Cleared Jul 16, 2012
VIGNET TELEHEALTH MANAGER
K113446 · DRG
Vignet, Inc.
Cardiovascular · 238d
Cleared Jul 16, 2012
HEARTRAIL III GUIDING CATHETER
K113335 · DQO
Terumo Corporation
Cardiovascular · 245d
Cleared Jul 16, 2012
CARDIO 7
K113306 · DPS
Bionet Co., Ltd.
Cardiovascular · 250d
Cleared Jul 13, 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · OCL
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jul 13, 2012
MANTARAY GUIDEWIRES
K121745 · DQX
Bridgepoint Medical
Cardiovascular · 29d
Cleared Jul 13, 2012
CRUX VENA CAVA FILTER SYSTEM
K120402 · DTK
Crux Biomedical
Cardiovascular · 156d
Cleared Jul 11, 2012
ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
K121856 · LIT
C.R. Bard, Inc.
Cardiovascular · 15d
Cleared Jul 11, 2012
MONGOOSE ANGIOGRAPHIC CATHETER
K113819 · DQO
Pediacath, Inc.
Cardiovascular · 197d
Cleared Jul 06, 2012
NAVIS TORQUER
K112674 · DQX
Navis Medical,Inc
Cardiovascular · 296d
Cleared Jul 03, 2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K121871 · MWI
Airstrip Technologies, LP
Cardiovascular · 6d
Cleared Jul 03, 2012
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
K121669 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 27d
Cleared Jul 03, 2012
COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT...
K121629 · DTK
William Cook Europe Aps
Cardiovascular · 29d
Cleared Jul 03, 2012
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
K120941 · DRG
Constant Care, LLC
Cardiovascular · 96d
Cleared Jul 03, 2012
PERICAM PSI
K120884 · DPT
Perimed AB
Cardiovascular · 102d
Cleared Jul 03, 2012
U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
K120634 · DXN
Taidoc Technology Corporation
Cardiovascular · 124d
Cleared Jun 29, 2012
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
K121175 · LIT
Ostial Corporation
Cardiovascular · 72d
Cleared Jun 29, 2012
INTELLISPACE ECG
K120855 · DQK
Philips Health Care
Cardiovascular · 100d