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

KGN 2021-01-07

MatriDerm

Applicant Medskin Solutions Dr. Suwelack AG

K-Number K201577

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FMF 2021-01-07

Instylla Delivery Kit

Applicant Instylla, Inc.

K-Number K202544

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KPR 2021-01-07

MULTIX Impact

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203345

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FTL 2021-01-07

SurgiWrap FROST

Applicant Mast Biosurgery

K-Number K200918

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MHX 2021-01-07

BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K202405

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ODP 2021-01-07

ZSFab Cervical Interbody System

Applicant Zsfab, Inc.

K-Number K202488

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LLZ 2021-01-07

BrainInsight

Applicant Hyperfine Research, Inc.

K-Number K202414

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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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