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

PCC 2021-06-17

Migraine Tens Digital Pain Reliever

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K-Number K210364

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HAW 2021-06-17

NaviNetics D1 Stereotactic System

Applicant Navinetics, Inc.

K-Number K210700

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EOQ 2021-06-17

aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8

Applicant Ambu A/S

K-Number K210883

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FLL 2021-06-17

Infrared Thermometer

Applicant Shenzhen Sonida Digital Technology Co., Ltd.

K-Number K202440

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DZE 2021-06-17

MIS Lance+ Conical Connection Dental Implant System

Applicant Dentsply Sirona

K-Number K210886

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KNF 2021-06-17

Sonata Transcervical Fibroid Ablation System 2.2

Applicant Gynesonics, Inc.

K-Number K211535

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OCW 2021-06-17

Su2ura Approximation Device

Applicant Anchora Medical, Ltd.

K-Number K201744

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IRP 2021-06-17

Fist Assist Devices Model FA-1

Applicant Fist Assist Devices, LLC

K-Number K210281

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JAK 2021-06-17

Precise Position

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K203514

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LRK 2021-06-16

Silent Nite Sleep Appliance with the Glidewell Hinge

Applicant Prismatik Dentalcraft, Inc.

K-Number K210694

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LZA 2021-06-16

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

Applicant Megine Industries Sdn Bhd

K-Number K211310

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LYZ 2021-06-16

Disposable Vinyl Examination Glove

Applicant Inner Mongolia Cureguard Medical Materials Co., Ltd.

K-Number K211336

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