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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
10873–10896 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 21, 1995
BRAUN MANIFOLD
K942391 · DTL
B.Braun Medical, Inc.
Cardiovascular · 398d
Cleared Jun 21, 1995
COWBOY X
K944567 · JOW
Kinetic Concepts, Inc.
Cardiovascular · 275d
Cleared Jun 21, 1995
EVOLUTION(TM) MICROCATHETER
K945666 · KRA
Boston Scientific Corp
Cardiovascular · 216d
Cleared Jun 21, 1995
LEMAITRE VALVULOTOME II
K946352 · MGZ
Vascutech, Inc.
Cardiovascular · 173d
Cleared Jun 21, 1995
FOCUS BALLOON DILATATION CATHETER
K952064 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 50d
Cleared Jun 20, 1995
SCHOLAR PATIENT MONITOR
K944860 · MHX
Criticare Systems, Inc.
Cardiovascular · 260d
Cleared Jun 20, 1995
1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES
K945836 · DRX
Conmed Andover Medical, Inc.
Cardiovascular · 203d
Cleared Jun 20, 1995
CARBOMEDICS EXENDED MITRAL ROTATOR
K951368 · MOP
Carbomedics, Inc.
Cardiovascular · 85d
Cleared Jun 16, 1995
DINAMAP PLUS VITAL SIGNS MONOITOR
K943709 · DPS
Critikon Company, LLC
Cardiovascular · 319d
Cleared Jun 16, 1995
PULSE*SPRAY INFUSION SYSTEM
K951509 · QEY
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 74d
Cleared Jun 15, 1995
STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY
K912035 · DTK
Boston Scientific Corp
Cardiovascular · 1498d
Cleared Jun 15, 1995
MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
K934086 · DXT
Medrad, Inc.
Cardiovascular · 660d
Cleared Jun 14, 1995
QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS
K951088 · DWF
Quest Medical, Inc.
Cardiovascular · 97d
Cleared Jun 14, 1995
PULSE*SPRAY INFUSION SYSTEM
K951602 · KRA
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 92d
Cleared Jun 08, 1995
C-THRU CORONARY GUIDE WIRE
K951109 · DQX
Schneider (Europe) GmbH
Cardiovascular · 90d
Cleared Jun 07, 1995
SONICAID MODEL MR-63 AMBULATORY ECG RECORDER
K943862 · DSH
Oxford Instruments Medical Systems
Cardiovascular · 303d
Cleared Jun 05, 1995
HEARTRAC ECG MONITORING SYSTEM
K934913 · QYW
Cardiac Telecom Corp.
Cardiovascular · 598d
Cleared Jun 05, 1995
PROTECTIVE SHORTS
K943948 · DXC
Y. Daneshvar, M.D.
Cardiovascular · 291d
Cleared Jun 05, 1995
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
K945379 · DQX
Boston Scientific Corp
Cardiovascular · 215d
Cleared Jun 05, 1995
DPD DEFIBRILLATOR
K952085 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 33d
Cleared Jun 02, 1995
NAVIGUIDE HYDROPHILIC GUIDE WIRE
K943358 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 325d
Cleared Jun 02, 1995
AORTIC ARCH CANNULAS
K943934 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 294d
Cleared Jun 02, 1995
MODEL 3200 VASCULAR MINI-LAB
K944495 · MHX
Parks Medical Electronics, Inc.
Cardiovascular · 262d
Cleared Jun 02, 1995
NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER
K945909 · KRA
Navarre Biomedical , Ltd.
Cardiovascular · 182d