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
8761–8784 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 05, 2001
MOBILE-PATIENT VIEWER
K011436 · DPS
Data Critical Corporation
Cardiovascular · 56d
Cleared Jul 03, 2001
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX,...
K011734 · DRF
Mogul Enterprises
Cardiovascular · 28d
Cleared Jul 03, 2001
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766 · DRF
St Jude Medical
Cardiovascular · 26d
Cleared Jul 03, 2001
BIOZTECT SENSOR AND BIOZTECT CABLE
K011797 · DSB
Cardiodynamics International Corp.
Cardiovascular · 25d
Cleared Jul 02, 2001
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
K011824 · DSI
Agilent Technologies, Inc.
Cardiovascular · 21d
Cleared Jun 29, 2001
HOME HEALTH MONITORING SYSTEM
K010029 · DXN
Avid Care Corp.
Cardiovascular · 177d
Cleared Jun 29, 2001
TRAM 2001 MODULE
K011000 · MHX
General Electric Medical Systems...
Cardiovascular · 87d
Cleared Jun 28, 2001
HOMMED OBSERVER, MODEL I
K003180 · DXN
Hommed, LLC
Cardiovascular · 260d
Cleared Jun 28, 2001
AVIVA SYSTEM, MODEL SL 2020
K003999 · MWI
American Telecare, Inc.
Cardiovascular · 184d
Cleared Jun 21, 2001
FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003,...
K010838 · DQY
Jomed AG
Cardiovascular · 93d
Cleared Jun 21, 2001
6F MACH 1, MODEL 34356-XXX
K010874 · DQY
Boston Scientific Corp
Cardiovascular · 90d
Cleared Jun 20, 2001
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
K011656 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Jun 18, 2001
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE...
K010974 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 77d
Cleared Jun 15, 2001
CORDIS M3 PTA DILATATION CATHETER
K003920 · DQY
Cordis Corp.
Cardiovascular · 178d
Cleared Jun 15, 2001
CRYOCARE CARDIAC SURGICAL SYSTEM
K011040 · OCL
Endocare, Inc.
Cardiovascular · 71d
Cleared Jun 14, 2001
PULSECO HEMODYNAMIC MONITOR CM71
K010049 · DXG
Lidco, Ltd.
Cardiovascular · 160d
Cleared Jun 14, 2001
COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
K010055 · DRE
Cook Vascular, Inc.
Cardiovascular · 157d
Cleared Jun 14, 2001
PORTABLE INSTENSIVE CARE UNIT
K010207 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 142d
Cleared Jun 14, 2001
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138
K011523 · DXN
Rossmax International , Ltd.
Cardiovascular · 28d
Cleared Jun 14, 2001
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129,...
K011526 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 28d
Cleared Jun 13, 2001
AVIATOR PERIPHERAL DILATATION CATHETER
K010831 · DQY
Guidant Corp.
Cardiovascular · 85d
Cleared Jun 13, 2001
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL...
K011464 · DQY
Vascular Intervention
Cardiovascular · 30d
Cleared Jun 12, 2001
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K010770 · MWI
Bci, Inc.
Cardiovascular · 90d
Cleared Jun 12, 2001
HEARTCARD, MODEL 5258
K010945 · DXH
Instromedix
Cardiovascular · 75d