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

GDW 2021-01-07

TissueTak device

Applicant Via Surgical , Ltd.

K-Number K203117

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LZA 2021-01-07

Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate

Applicant O&M Halyard, Inc.

K-Number K202622

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NGX 2021-01-06

BTL-703-2

Applicant Btl

K-Number K200382

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DXN 2021-01-06

InBody

Applicant Inbody Co., Ltd.

K-Number K200560

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DXQ 2021-01-06

Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D

Applicant Jkh USA, LLC

K-Number K203652

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KPR 2021-01-06

MULTIX Impact C

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203340

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LHQ 2021-01-06

Thermidas IR System (ThIR-A615)

Applicant Thermidas Americas, Inc.

K-Number K200999

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MAX 2021-01-06

SIRION Lateral Lumbar Interbody Fusion

Applicant Astura Medical, LLC

K-Number K202495

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FXX 2021-01-06

Medical Surgical Masks-Non Sterile

Applicant Shandong T&F Nonwoven Co., Ltd.

K-Number K202594

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FXX 2021-01-06

Disposable Surgical Face Mask

Applicant Jiangsu Newvalue Medical Products Co., Ltd.

K-Number K202491

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KTT 2021-01-06

AutoStrut G2

Applicant Orthospin, Ltd.

K-Number K202810

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HTY 2021-01-06

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design

Applicant OSSIO , Ltd.

K-Number K203465

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