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

FXX 2021-07-02

Disposable Surgical Mask

Applicant Xiamen Probtain Medical Techology Co., Ltd.

K-Number K202954

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MRX 2021-07-02

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

Applicant Hamilton Thorne, Inc.

K-Number K202241

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MUU 2021-07-02

SyntrFuge System

Applicant Syntr Health Technologies, Inc.

K-Number K203800

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LKM 2021-07-02

iQ200 System, iChemVELOCITY Automated Urine Chemistry System

Applicant Beckman Coulter, Inc.

K-Number K210127

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PDJ 2021-07-02

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K200256

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IRP 2021-07-02

LX9max

Applicant Daesung Maref Co., Ltd.

K-Number K203498

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EIH 2021-07-02

Estar-Z

Applicant Osstem Implant Co., Ltd.

K-Number K210097

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FXX 2021-07-02

Single-use Medical Face Mask

Applicant Conod Medical Co., Limited

K-Number K203591

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FYA 2021-07-02

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown

Applicant Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

K-Number K211422

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GEX 2021-07-02

The Alma Hybrid Laser System

Applicant Alma Lasers , Ltd.

K-Number K203441

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MEG 2021-07-02

Insulin Syringe, Insulin Syringe with Safety Retractable

Applicant Jiangsu Micsafe Medical Technology Co., Ltd.

K-Number K202570

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LOX 2021-07-02

Selethru(TM) NC PTCA Balloon Dilatation Catheter

Applicant Kossel Medtech (Suzhou) Co., Ltd.

K-Number K211393

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