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

EIH 2023-06-09

BruxZir™ TintEFX Coloring Liquid

Applicant Prismatik Dentalcraft, Inc.

K-Number K231347

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MAI 2023-06-09

Fixone Biocomposite Anchor

Applicant Aju Pharm Co., Ltd.

K-Number K230892

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JWH 2023-06-09

MyKnee UNI-ST

Applicant Medacta International S.A.

K-Number K231037

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NGX 2023-06-09

Bemer Therapy System Evo

Applicant Bemer Int AG

K-Number K231368

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IYN 2023-06-09

M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K230768

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MAX 2023-06-09

RODIN™ Expandable Lumbar Cage System

Applicant Ctl Medical Corporation

K-Number K231359

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GEI 2023-06-09

Renuvion® Micro Handpiece

Applicant Apyx Medical Corporation

K-Number K230586

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PLH 2023-06-09

OrthoPulse 2.0E (OPi2E-100)

Applicant Biolux Technology GmbH

K-Number K230905

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HGX 2023-06-09

Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)

Applicant Shenzhen Lutejiacheng Technology Co., Ltd.

K-Number K230776

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OMB 2023-06-09

LVIS NeuroMatch

Applicant LVIS Corporation

K-Number K222450

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OAS 2023-06-09

Orthopantomograph™ OP 3D LX

Applicant Palodex Group OY

K-Number K230505

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LZA 2023-06-09

Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Shanxi Hongjin Plastic Technology Co., Ltd.

K-Number K230779

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