Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DQX 2019-12-13

CrossTorq 14 Guidewire

Applicant Scientia Cardio Access, LLC

K-Number K193194

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MWP 2019-12-13

CoreLite X-Ray Specimen Cabinet

Applicant Cirdan Imaging Limited

K-Number K193317

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FDT 2019-12-13

EXALT Model D Single-Use Duodenoscope, EXALT Controller

Applicant Boston Scientific Corporation

K-Number K193202

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OLO 2019-12-13

Corelink Navigation Instruments

Applicant Corelink, LLC

K-Number K182731

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PHX 2019-12-13

MyShoulder Placement Guides

Applicant Medacta International S.A.

K-Number K190738

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MHX 2019-12-13

C50 and C80 Multi-parameter Patient Monitor

Applicant Shenzhen Comen Medical Instruments Co.,Ltd

K-Number K191106

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MAX 2019-12-13

Neo Cage System

Applicant Neo Medical SA

K-Number K191796

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LLZ 2019-12-13

QyScore Software

Applicant Qynapse

K-Number K192531

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OCL 2019-12-13

EPi-Sense Guided Coagulation System with VisiTrax

Applicant AtriCure, Inc.

K-Number K193162

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KPJ 2019-12-13

EPIFLO-28

Applicant Neogenix, LLC Dba Ogenix

K-Number K190742

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DXT 2019-12-13

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

Applicant Bayer Medical Care, Inc.

K-Number K192370

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LLZ 2019-12-13

Icobrain

Applicant Icometrix NV

K-Number K192130

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