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
2593–2616 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 08, 2018
Accutension Smartphone Auscultatory Blood
K180335 · DXQ
Shanghai Hulu Devices Co., Ltd.
Cardiovascular · 30d
Cleared Mar 08, 2018
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -...
K180105 · QEW
Penumbra, Inc.
Cardiovascular · 51d
Cleared Mar 06, 2018
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K173262 · OWQ
Innovative Health, LLC
Cardiovascular · 146d
Cleared Mar 02, 2018
Wrist Type Automatic Blood Pressure Monitor
K172972 · DXN
Shenzhen Jiacom Technology CO ., Ltd.
Cardiovascular · 157d
Cleared Mar 02, 2018
Type I, Type II, Type III, Type IV
K172331 · DYB
Lepu Medical Technology (Beijing)...
Cardiovascular · 212d
Cleared Mar 02, 2018
Flowtron DVT5 Small Calf Garment
K172103 · JOW
Getinge (Suzhou) Co., Ltd.
Cardiovascular · 233d
Cleared Mar 01, 2018
CorPath GRX System
K173806 · DXX
Corindus, Inc.
Cardiovascular · 76d
Cleared Mar 01, 2018
Sapphire II PRO
K173680 · LOX
Orbusneich Medical Trading, Inc.
Cardiovascular · 90d
Cleared Feb 28, 2018
EnsoETM
K180244 · PLA
Advanced Cooling Therapy, Inc. D/B/A...
Cardiovascular · 30d
Cleared Feb 28, 2018
HeRO Symphony, HeRO ES, HeRO solo/duet
K180242 · DPS
Medical Predictive Science Corporation
Cardiovascular · 30d
Cleared Feb 28, 2018
ECG Cable/Leadwires
K172797 · DSA
Shenzhen Coreray Technology, Ltd.
Cardiovascular · 166d
Cleared Feb 26, 2018
Bluetooth blood pressure monitor
K171668 · DXN
Visiomed Group SA
Cardiovascular · 266d
Cleared Feb 22, 2018
Nexxis OR
K173381 · DXJ
Barco N.V.
Cardiovascular · 115d
Cleared Feb 22, 2018
Sentry IVC Filter
K173236 · DTK
Novate Medical , Ltd.
Cardiovascular · 140d
Cleared Feb 21, 2018
TSN Transseptal Needle
K172950 · DRC
Pressure Products Medical Device...
Cardiovascular · 148d
Cleared Feb 21, 2018
PiCCO Catheter
K171620 · KRB
Pulsion Medical Systems SE
Cardiovascular · 264d
Cleared Feb 21, 2018
Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
K170866 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 335d
Cleared Feb 20, 2018
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry...
K172423 · DQE
Edwards Lifescience, LLC
Cardiovascular · 194d
Cleared Feb 16, 2018
Warrior 14 guidewire
K180128 · DQX
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Feb 16, 2018
Needle Free Transseptal Cannula
K172934 · DRC
Pressure Products Medical Device...
Cardiovascular · 144d
Cleared Feb 16, 2018
ACISTCVi® Contrast Delivery System
K171646 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 256d
Cleared Feb 15, 2018
Prelude IDeal Hydrophilic Sheath Introducer
K173750 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 69d
Cleared Feb 15, 2018
CorPath GRX System
K173288 · DXX
Corindus, Inc.
Cardiovascular · 122d
Cleared Feb 12, 2018
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro...
K171933 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 229d