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

GEX 2018-11-14

New Era

Applicant Step UP Skin Laser, LLC

K-Number K182604

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NEW 2018-11-14

Miracu

Applicant Feeltech Co., Ltd.

K-Number K172602

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MSX 2018-11-14

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package

Applicant Snap40, Ltd.

K-Number K182543

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GEI 2018-11-14

Voyant Maryland Fusion Device

Applicant Applied Medical Resources Corp.

K-Number K182653

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NUC 2018-11-14

JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant

Applicant United Consortium

K-Number K182105

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CBI 2018-11-14

VivaSight-DL System

Applicant Etview , Ltd.

K-Number K181886

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NRY 2018-11-14

Riptide Aspiration System (React 71 Catheter)

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K182101

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KPI 2018-11-14

HPM-6000UF

Applicant BTL Industries, Inc.

K-Number K181497

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MAX 2018-11-14

ostaPek Interbody Fusion Cages

Applicant Coligne AG

K-Number K181963

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LPL 2018-11-13

Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia

Applicant Largan Medical Co., Ltd.

K-Number K182674

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NKG 2018-11-13

Saxxony Posterior Cervical Thoracic System

Applicant Nexxt Spine, LLC

K-Number K182508

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NKB 2018-11-13

VersaLink Fixation System

Applicant Premia Spine, Ltd.

K-Number K182598

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