Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,182 results
2545–2568 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 20, 2018
WATCHMAN TruSeal Access System
K180864 · DQY
Boston Scientific
Cardiovascular · 109d
Cleared Jul 19, 2018
Clarifi Imaging System
K181623 · MUD
Modulated Imaging, Inc.
Cardiovascular · 29d
Cleared Jul 18, 2018
ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES
K180784 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 114d
Cleared Jul 18, 2018
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
K173762 · DQO
AngioDynamics, Inc.
Cardiovascular · 219d
Cleared Jul 16, 2018
Philips IntelliVue GuardianSoftware
K180534 · DXJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 138d
Cleared Jul 16, 2018
MC3 Jugular Dual Lumen Catheter
K180151 · PZS
Mc3 Incorporated
Cardiovascular · 178d
Cleared Jul 11, 2018
Medicalgorithmics Unified Cardiac Rehabilitation System
K173969 · DSI
Medicalgorithmics S.A.
Cardiovascular · 194d
Cleared Jul 06, 2018
Sterile Disposable Syringes
K172694 · DXT
Shenyang Mastech Medical Device Co.,...
Cardiovascular · 302d
Cleared Jul 05, 2018
ASAHI PTCA Guide Wire ASAHI SION black
K173277 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 265d
Cleared Jul 05, 2018
CheckMyHeart Plus
K172778 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 294d
Cleared Jul 04, 2018
React 68 Catheter
K180715 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Cardiovascular · 107d
Cleared Jun 29, 2018
Venera 508 Deep Vein Thrombosis (DVT) Prevention System
K180389 · JOW
Suzhou Minhua Medical Apparatus...
Cardiovascular · 136d
Cleared Jun 28, 2018
ArtiClip LAA Exclusion System
K181474 · PZX
AtriCure, Inc.
Cardiovascular · 24d
Cleared Jun 28, 2018
Sapphire II PRO Balloon Dilatation Catheter
K180921 · LOX
Orbusneich Medical Trading, Inc.
Cardiovascular · 80d
Cleared Jun 28, 2018
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
K172457 · DPW
Deltex Medical Limited
Cardiovascular · 318d
Cleared Jun 27, 2018
Shockwave Medical Intravascular Lithotripsy (IVL) System
K180454 · PPN
Shockwave Medical, Inc.
Cardiovascular · 127d
Cleared Jun 22, 2018
IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE...
K181051 · KRD
Shape Memory Medical
Cardiovascular · 63d
Cleared Jun 22, 2018
Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo...
K180950 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 72d
Cleared Jun 22, 2018
iSLEEVE Introducer Set
K180785 · DYB
Boston Scientific Corporation
Cardiovascular · 88d
Cleared Jun 22, 2018
AIROS 8 Sequential Compression Device
K172779 · JOW
Airos Medical, Inc.
Cardiovascular · 281d
Cleared Jun 22, 2018
AIROS 6 Sequential Compression Device
K172770 · JOW
Airos Medical, Inc.
Cardiovascular · 281d
Cleared Jun 22, 2018
Vios Monitoring System™ Model 2050
K172586 · DRT
Vios Medical, Inc.
Cardiovascular · 298d
Not Cleared Jun 22, 2018
Ellipsys Vascular Access System
DEN170004 · PQK
Avenu Medical, Inc.
Cardiovascular · 528d
Not Cleared Jun 22, 2018
everlinQ endoAVF System
DEN160006 · PQK
Tva Medical, Inc.
Cardiovascular · 870d