Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

LRK 2018-06-26

Express 4 Sleep appliance/CPAP Sidekick appliance

Applicant Moses Appliances, LLC

K-Number K173856

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OLO 2018-06-25

Navigation Instruments

Applicant Globus Medical, Inc.

K-Number K180690

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ODP 2018-06-25

EVOL® ha-C Cervical Interbody Fusion System

Applicant Cutting Edge Spine, LLC

K-Number K180674

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LLL 2018-06-25

QUANTA Flash HMGCR Reagents

Applicant Inova Diagnostics, Inc.

K-Number K180975

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IYN 2018-06-25

Vscan Extend

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K180995

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MAX 2018-06-25

SPIRA Open Matrix LLIF

Applicant Camber Spine Technologies, LLC

K-Number K180724

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GAP 2018-06-25

SafePath Suturing System

Applicant Safepath Medical, Inc.

K-Number K180701

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LPL 2018-06-25

Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA

Applicant Largan Medical Co., Ltd.

K-Number K181230

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ODP 2018-06-25

MONET™ Anterior Cervical Interbody Fusion Cage System

Applicant Ctl Medical Corporation

K-Number K172788

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MSV 2018-06-25

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

Applicant Phadia AB

K-Number K181329

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OVB 2018-06-25

SpaceOAR System

Applicant Augmenix, Inc.

K-Number K181465

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NUH 2018-06-22

Wireless Pain Relieve Device

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K-Number K180331

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