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
10129–10152 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 15, 1997
P.H.D. - PERSONAL HEART DEVICE MODEL 5258
K963904 · DXH
Heart Alert, Inc.
Cardiovascular · 227d
Cleared May 15, 1997
HEWLETT-PACKARD CENTRALVUE SOFTWARE
K964832 · DSI
Hewlett-Packard Co.
Cardiovascular · 164d
Cleared May 15, 1997
700-SP SERIES DISPOSABLE STIMULATION ELECTRODES
K971148 · MKJ
Cardiotronics Systems, Inc.
Cardiovascular · 48d
Cleared May 14, 1997
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
K964518 · DYB
Daig Corp.
Cardiovascular · 201d
Cleared May 14, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)
K970784 · DXG
Alexander Mfg. Co.
Cardiovascular · 71d
Cleared May 14, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
K970787 · DPS
Alexander Mfg. Co.
Cardiovascular · 71d
Cleared May 13, 1997
CHASE LEFT VENT SAFETY VALVE
K964391 · DWF
Chase Medical, Inc.
Cardiovascular · 190d
Cleared May 13, 1997
CHASE AORTIC PERFUSION CANNULA
K970914 · DWF
Chase Medical, Inc.
Cardiovascular · 62d
Cleared May 13, 1997
CHASE CORONARY OSTIAL PERFUSION CANNULA
K971041 · DWF
Chase Medical, Inc.
Cardiovascular · 53d
Cleared May 09, 1997
HEARTPORT THORACIC TROCAR
K964302 · DRC
Heartport, Inc.
Cardiovascular · 192d
Cleared May 09, 1997
HANNIBAL GUIDEWIRE
K970494 · DQX
Schneider (Europe) GmbH
Cardiovascular · 88d
Cleared May 09, 1997
HEARTPORT MAZE SYSTEM: CRYOPROBE SET
K970496 · OCL
Heartport, Inc.
Cardiovascular · 88d
Cleared May 09, 1997
OPTI-PLAST XL 5.5 F PTA CATHETER
K970725 · LIT
Vas-Cath, Inc.
Cardiovascular · 70d
Cleared May 08, 1997
EVT ANGIOSCALE ANGIOGRAPHIC CATHETER
K970469 · DQO
Guidant Cardiac and Vascular Surgery
Cardiovascular · 90d
Cleared May 08, 1997
DASH 1000 PATIENT MONITOR
K970545 · DSI
Marquette Medical Systems, Inc.
Cardiovascular · 85d
Cleared May 07, 1997
VISTA BRITE TIP CATHETERS
K963962 · DQY
Cordis Corp.
Cardiovascular · 217d
Cleared May 07, 1997
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
K964814 · DYB
Bipore, Inc.
Cardiovascular · 159d
Cleared May 06, 1997
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
K955816 · DYG
Baxter Healthcare Corp
Cardiovascular · 497d
Cleared May 06, 1997
3F ANGIOPTIC ANGIOGRAPHIC CATHETER
K964033 · DQO
AngioDynamics, Inc.
Cardiovascular · 210d
Cleared May 06, 1997
TRANSJUGULAR ACCESS SET
K964034 · DYB
AngioDynamics, Inc.
Cardiovascular · 210d
Cleared May 06, 1997
HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT
K964188 · JOW
Healthcare Service and Supply
Cardiovascular · 197d
Cleared May 06, 1997
CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL...
K970463 · DTZ
Terumo Medical Corp.
Cardiovascular · 89d
Cleared May 06, 1997
CORDIS OPTA5 PTA BALLOON CATHETER
K970620 · LIT
Cordis Corp.
Cardiovascular · 77d
Cleared May 05, 1997
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
K964625 · DSY
Intervascular, Inc.
Cardiovascular · 171d