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

LZU 2019-10-24

Tear Pool Dissolvable Punctum Plugs

Applicant Alphamed, Inc.

K-Number K190210

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KGO 2019-10-24

Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein

Applicant Lenora Glove Pvt , Ltd.

K-Number K190632

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KWQ 2019-10-24

Genesys Spine Binary® Lumbar Plate System

Applicant Genesys Spine

K-Number K192678

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LNH 2019-10-24

Upgrade Kit MR GUI PRO, MrJ 3300 Plus

Applicant Asg Superconductors S.P.A.

K-Number K192690

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JAK 2019-10-24

Revolution Maxima, Revolution Ace

Applicant Ge Hangwei Medical Systems Co., Ltd.

K-Number K192686

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PLR 2019-10-24

ALTA Anterior Cervical Corpectomy System

Applicant Astura Medical, LLC

K-Number K190426

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MQP 2019-10-24

MediExpand TL Expandable VBR System

Applicant Cmf Medicon Surgical, Inc.

K-Number K190349

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ODP 2019-10-24

ADI Cervical Interbody Fusion Device

Applicant Additive Device, Inc. (Adi) D/B/A Restor3D

K-Number K191812

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LZC 2019-10-23

Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs

Applicant Encompass Industries Sdn. Bhd.

K-Number K183562

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ONB 2019-10-23

Diana ChemoClave Transfer Set

Applicant Icu Medical

K-Number K190157

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FMI 2019-10-23

Intraosseous infusion device

Applicant Einstein Works, LLC

K-Number K191258

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NWA 2019-10-23

Patient-Specific Airway Stent

Applicant New Cos, Inc.

K-Number K182743

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