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

EBZ 2020-01-10

Cybird LED Curing Light

Applicant Dxm Co., Ltd.

K-Number K191221

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PHX 2020-01-10

Univers Revers Modular Glenoid System (Augemented baseplates)

Applicant Arthrex, Inc.

K-Number K193372

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NKB 2020-01-10

CD Horizon™ Fenestrated Screw Set

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K193011

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DPW 2020-01-10

FlowMet

Applicant Laser Associated Sciences, Inc.

K-Number K192966

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KWL 2020-01-10

OsteoRemedies Hip Spacer System

Applicant Osteoremedies, LLC

K-Number K192995

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CBK 2020-01-10

Nihon Kohden NKV-550 Series Ventilator System

Applicant Nihon Kohden Orangemed, Inc.

K-Number K192307

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NKB 2020-01-10

CorticaLINK Spinal Fusion Platform

Applicant Spine Smith Holdings, LLC

K-Number K193465

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MAX 2020-01-09

TrellOss™-L MPF

Applicant Nexxt Spine, LLC

K-Number K192687

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MQV 2020-01-09

Altapore

Applicant Baxter Healthcare Corporation

K-Number K192363

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MJN 2020-01-09

ER-REBOA PLUS Catheter

Applicant Prytime Medical Devices, Inc.

K-Number K193440

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NUC 2020-01-09

HyaloGYN Vaginal Moisturizing Suppositories

Applicant Fidia Farmaceutici S.P.A.

K-Number K191052

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HWC 2020-01-09

Tyber Medical Trauma Screws

Applicant Tyber Medical, LLC

K-Number K192975

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