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

FXX 2022-02-24

ROKI Surgical Mask

Applicant Roki Co., Ltd.

K-Number K214094

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MEG 2022-02-24

Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use

Applicant Henan Nursecare Biotechnology Co., Ltd.

K-Number K212949

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NFO 2022-02-24

Luminice

Applicant Premier North America, Inc.

K-Number K214100

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MQC 2022-02-23

Glidewell Appliance Resin, Hard/Soft

Applicant Prismatik Dentalcraft, Inc.

K-Number K214102

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HIF 2022-02-23

LevaLap Laparoscopic Access Device

Applicant Core Access Surgical Technologies, Inc.

K-Number K212786

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HRS 2022-02-23

Arsenal Ankle Plating System

Applicant Trilliant Surgical

K-Number K212378

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FBK 2022-02-23

Sclerotherapy Needle

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K212668

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PLF 2022-02-23

Trigon HA Wedge Fixation System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K220197

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LLZ 2022-02-23

EzOrtho v1.3

Applicant Ewoosoft Co., Ltd.

K-Number K220003

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QRZ 2022-02-23

ONE Male Condom

Applicant Global Protection Corp.

K-Number DEN210034

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DZE 2022-02-23

SuperLine

Applicant Dentium Co., Ltd.

K-Number K213599

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NKG 2022-02-23

NuVasive Reline Cervical System

Applicant Nu Vasive, Incorporated

K-Number K213654

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