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
8929–8952 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 18, 2001
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING
K003492 · DQK
Cambridge Heart, Inc.
Cardiovascular · 66d
Cleared Jan 18, 2001
TRAK BACK II
K003938 · DQO
Jomed, Inc.
Cardiovascular · 29d
Cleared Jan 17, 2001
PHLEBOPUMP, MODEL 1000
K003284 · JOW
Prevent Products, Inc.
Cardiovascular · 90d
Cleared Jan 17, 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901 · DQO
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared Jan 12, 2001
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
K001775 · DRT
Zoe Medical, Inc.
Cardiovascular · 214d
Cleared Jan 11, 2001
OUTBACK CATHETER
K001577 · DQY
Lumend, Inc.
Cardiovascular · 234d
Cleared Jan 11, 2001
RADIANALYZER, MODEL 12710
K002067 · DSK
Radi Medical Systems AB
Cardiovascular · 188d
Cleared Jan 11, 2001
CARE PROVIDER STATION ADDITION OF WEIGHT SCALE
K003485 · DQD
Cybercare Technologies, Inc.
Cardiovascular · 85d
Cleared Jan 11, 2001
MULTITRACK ANGIOGRAPHIC CATHETER
K003902 · DQO
NuMED, Inc.
Cardiovascular · 23d
Cleared Jan 11, 2001
NUMED GHOST II PTA CATHETERS
K003972 · LIT
NuMED, Inc.
Cardiovascular · 20d
Cleared Jan 09, 2001
VENODYNE DVT ADVANTAGE MODEL 610
K001802 · JOW
Microtek Medical, Inc.
Cardiovascular · 209d
Cleared Jan 09, 2001
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072 · DTB
Biotronik, Inc.
Cardiovascular · 98d
Cleared Jan 08, 2001
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS
K001896 · DPS
Suzuken Co., Ltd.
Cardiovascular · 201d
Cleared Jan 08, 2001
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
K002603 · LDF
Zcv ,Inc.
Cardiovascular · 139d
Cleared Jan 08, 2001
FLEXIBLE OCCLUSION SYSTEM
K002915 · DXC
Applied Medical
Cardiovascular · 112d
Cleared Jan 08, 2001
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
K003925 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 19d
Cleared Jan 08, 2001
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND...
K990800 · DSY
Intervascular, Inc.
Cardiovascular · 670d
Cleared Jan 05, 2001
2010 PLUS HOLTER FOR WINDOWS
K003763 · MLO
Agilent Technologies
Cardiovascular · 30d
Cleared Jan 03, 2001
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
K003415 · DXQ
Wang & Li, Inc.
Cardiovascular · 62d
Cleared Jan 03, 2001
ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER...
K003729 · DYB
St Jude Medical
Cardiovascular · 30d
Cleared Dec 27, 2000
SURGISIS PERIPHERAL VASCULAR PATCH
K001785 · DXZ
Cook Biotech, Inc.
Cardiovascular · 197d
Cleared Dec 27, 2000
CARTOUCH
K002197 · DPS
Cardionics, Inc.
Cardiovascular · 160d
Cleared Dec 27, 2000
NUMED Z-MED PTV CATHERERS
K003643 · DQY
NuMED, Inc.
Cardiovascular · 30d
Cleared Dec 22, 2000
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER,...
K002976 · DRF
St Jude Medical
Cardiovascular · 88d