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
2473–2496 of 18,110
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