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
7345–7368 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 22, 2005
GS-128 GRADIENT COMPRESSION SYSTEM
K050584 · JOW
Medmark Technologies, LLC
Cardiovascular · 15d
Cleared Mar 22, 2005
PIVOT STEERABLE MICROCATHETER
K050630 · KRA
Boston Scientific - Precision Vascular
Cardiovascular · 11d
Cleared Mar 21, 2005
KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K042418 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 199d
Cleared Mar 21, 2005
CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8
K042999 · DQK
Biosense Webster, Inc.
Cardiovascular · 140d
Cleared Mar 17, 2005
V-BAG WITH GBS COATING
K050195 · DTN
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Mar 16, 2005
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
K033436 · OWQ
Alliance Medical Corp.
Cardiovascular · 505d
Cleared Mar 16, 2005
SPECTRANETICS LLD CS, MODEL 518-039
K043401 · DRB
Spectranetics Corp.
Cardiovascular · 96d
Cleared Mar 11, 2005
LYSUS INFUSION SYSTEM
K050472 · DRA
Ekos Corp.
Cardiovascular · 15d
Cleared Mar 10, 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K040751 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 351d
Cleared Mar 10, 2005
HYPERQ SYSTEM
K042981 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 132d
Cleared Mar 09, 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K042074 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 219d
Cleared Mar 09, 2005
DIASYS INTEGRA II
K042109 · DXN
Novacor France
Cardiovascular · 216d
Cleared Mar 08, 2005
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
K050111 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 49d
Cleared Mar 08, 2005
PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K050447 · DTZ
Dideco S.R.L.
Cardiovascular · 14d
Cleared Mar 07, 2005
DIVER C.E. CATHETER
K050276 · QEZ
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 28d
Cleared Mar 04, 2005
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050175 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 37d
Cleared Mar 04, 2005
BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH
K050205 · KRA
Flowmedica, Inc.
Cardiovascular · 35d
Cleared Mar 04, 2005
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600
K050413 · DXN
Amplife Corporation
Cardiovascular · 14d
Cleared Mar 03, 2005
A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR
K043217 · DXN
A&D Engineering, Inc.
Cardiovascular · 101d
Cleared Mar 02, 2005
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060
K041374 · QEW
Idev Technologies, Inc.
Cardiovascular · 282d
Cleared Mar 02, 2005
GALEO FOCUS GUIDE WIRE
K042373 · DQX
Biotronik, Inc.
Cardiovascular · 182d
Cleared Mar 01, 2005
TRIFIT 700
K033646 · DRT
Healthfirst Corp.
Cardiovascular · 467d
Cleared Mar 01, 2005
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
K043398 · DQX
Neometrics, Inc.
Cardiovascular · 81d
Cleared Mar 01, 2005
STERILEMED REPROCESSED IVUS IMAGING CATHETER
K043453 · OWQ
Sterilmed, Inc.
Cardiovascular · 76d