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

NXC 2021-01-05

ClearPath Aligner

Applicant Clearpath Orthodontics, Ltd.

K-Number K202857

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FLL 2021-01-05

iHealth Clinical Digital Thermometer

Applicant Andon Health Co, Ltd.

K-Number K202791

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MMX 2021-01-05

Halo Single-Loop Microsnare Kit

Applicant Argon Medical Devices, Inc.

K-Number K200963

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GEI 2021-01-04

J-Plasma Precise FLEX Handpiece

Applicant Apyx Medical Corporation (Formerly Bovie Medical Corporation

K-Number K202880

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FXX 2021-01-04

Disposable Medical Face Masks

Applicant Jiangxi Sanxin Medtec Co., Ltd.

K-Number K202719

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OLO 2021-01-04

ChoiceSpine Navigation System

Applicant Choice Spine, LLC

K-Number K203561

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PZR 2021-01-02

Sparrow Therapy System

Applicant Spark Biomedical, Inc.

K-Number K201873

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JCT 2020-12-31

HANAROSTENT Trachea/Bronchium (CCC)

Applicant M.I.Tech Co., Ltd.

K-Number K201342

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PZO 2020-12-31

Sim&Size

Applicant Sim&Cure

K-Number K202322

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FXX 2020-12-31

Nordiwell Medical Face Mask

Applicant Changzhou Combat Protective Equipment Co., Ltd.

K-Number K202615

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KXK 2020-12-31

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

Applicant Isoray Medical, Inc.

K-Number K202267

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FMI 2020-12-31

Promisemed Covered Safety Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K202681

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