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

HSB 2022-11-14

Smith & Nephew Intramedullary Nail Systems

Applicant Smith & Nephew, Inc.

K-Number K210980

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FXX 2022-11-14

Surgical Face Mask

Applicant Xiantao Rayxin Medical Products Co., Ltd.

K-Number K222529

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FXX 2022-11-14

High Fluid-Resistant Surgical and Procedure Mask

Applicant America’S Supply Chains

K-Number K222749

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OVE 2022-11-14

Hexanium ACIF

Applicant Spinevision, S.A.S.

K-Number K221578

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HRX 2022-11-14

HBL Blade Assembly

Applicant Hand Biomechanics Lab, Inc.

K-Number K222490

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EIH 2022-11-14

Zirconia Block

Applicant Yilink (Tianjin) Biotechnology Co., Ltd.

K-Number K222520

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PKL 2022-11-14

Disposable hemoclip

Applicant Beijing Zksk Technology Co., Ltd.

K-Number K213217

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FYA 2022-11-14

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K-Number K222480

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DYB 2022-11-14

Multiflex Steerable Sheath

Applicant Vizaramed, Inc.

K-Number K221655

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LZA 2022-11-12

Nitrile Examination Gloves

Applicant Emerald Glove Manufacturing Sdn Bhd

K-Number K213981

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LZA 2022-11-11

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K222225

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IYN 2022-11-11

ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System

Applicant Imsonic Medical China, Inc.

K-Number K220983

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