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

OAP 2021-04-16

Hair Growth Device

Applicant Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd.

K-Number K210169

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LZA 2021-04-16

Disposable Nitrile Gloves

Applicant Fujian Ercon Medical Management Co., Ltd.

K-Number K210276

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QFM 2021-04-16

Saige-Q

Applicant DeepHealth, Inc.

K-Number K203517

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NEU 2021-04-16

MOLLI

Applicant Molli Surgical, Inc.

K-Number K210600

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LZO 2021-04-16

Fusion Taper System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K201047

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FLL 2021-04-16

Infrared Thermometer Models: DT-8806S, DT-8807S

Applicant Shenzhen Everbest Machinery Industry Co., Ltd.

K-Number K203170

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LZA 2021-04-16

BIOTECH Nitrile Examination Gloves

Applicant Tk Hitech Technology Co., Ltd.

K-Number K202419

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OAS 2021-04-16

rainbow MCT

Applicant Dentium Co., Ltd (Ict Branch)

K-Number K200270

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QMD 2021-04-16

Brainsway Deep (DTMS) System

Applicant Brainsway , Ltd.

K-Number K203616

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OAS 2021-04-16

rainbow CT

Applicant Dentium Co., Ltd (Ict Branch)

K-Number K200271

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DZE 2021-04-15

Locator Overdenture Implant System

Applicant Ivory Super Holdco Inc. / Zest Anchors, LLC

K-Number K203701

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NKB 2021-04-15

CoreLink Midline Fixation System

Applicant Corelink, LLC

K-Number K210539

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