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

BWF 2019-10-24

Acapella Choice Blue Vibratory PEP Device

Applicant Smiths Medical

K-Number K181660

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PKL 2019-10-24

Padlock Clip defect closure system, Padlock Pro-Select defect closure device

Applicant STERIS Corporation

K-Number K192722

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IYE 2019-10-24

MU2net

Applicant Dosisoft

K-Number K191944

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LZU 2019-10-24

Tear Pool Dissolvable Punctum Plugs

Applicant Alphamed, Inc.

K-Number K190210

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KGO 2019-10-24

Latex Surgeons 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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