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

KWS 2023-06-23

AltiVate® Anatomic Shoulder AG e+ with Markers

Applicant Encore Medical L.P.

K-Number K222592

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PHR 2023-06-23

Black Diamond

Applicant Elevate Oral Care, LLC

K-Number K222323

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FOZ 2023-06-23

Mais Central Venous Catheter

Applicant Saudi Mais Co. For Medical Products

K-Number K221827

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LEL 2023-06-23

ActiGraph LEAP activity monitor (ActiGraph LEAP)

Applicant Actigraph, LLC

K-Number K231532

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PML 2023-06-23

PERLA® TL System; TEKTONA® HV US Bone Cement

Applicant Spineart

K-Number K230774

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HDR 2023-06-23

FERTI-LILY Conception Cup

Applicant Rosesta Medical BV

K-Number K222969

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OAP 2023-06-23

Neuhat Hair Growth System; ibeauty.com Laser Cap

Applicant Nature, Inc.redible, Inc.

K-Number K231153

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LFL 2023-06-23

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, LLC, A Bioventus Company

K-Number K231117

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QLU 2023-06-23

HemosIL Liquid Anti-Xa

Applicant Instrumentation Laboratory CO

K-Number K223187

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DSY 2023-06-23

GORE® ACUSEAL Vascular Graft

Applicant W. L. Gore & Associates, Inc.

K-Number K231505

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CAF 2023-06-23

Hudson RCI Variable concentration Large Volume Nebulizer (1770)

Applicant Medline Industires, Inc.

K-Number K220955

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IYE 2023-06-23

Radixact Treatment Delivery System

Applicant Accuray Incorporated

K-Number K223159

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