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

GEI 2023-02-23

Renuvion® APR Handpiece

Applicant Apyx Medical Corporation

K-Number K223262

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IYE 2023-02-23

MOSAIQ® OIS (Oncology Information System)

Applicant Elekta Solutions AB

K-Number K223229

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KPR 2023-02-23

Jumong General

Applicant Sg Healthcare Co, Ltd.

K-Number K230241

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HQF 2023-02-23

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

Applicant Iridex Corporation

K-Number K230228

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NGX 2023-02-23

Neuro20 Pro System

Applicant Neuro20 Technologies

K-Number K223797

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GCJ 2023-02-23

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source

Applicant Schoelly Fiberoptic GmbH

K-Number K221591

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MNR 2023-02-23

Belun Sleep System BLS-100

Applicant Belun Technology Company Limited

K-Number K222579

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MSX 2023-02-23

Everion+ System

Applicant Biofourmis Singapore Pte., Ltd.

K-Number K213863

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GCJ 2023-02-23

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)

Applicant Stryker

K-Number K230216

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FYA 2023-02-23

Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3

Applicant Stringking

K-Number K221559

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OHS 2023-02-23

LED light therapy mask (FM-01, FM-02, FM-03)

Applicant Guangdong Newdermo Biotech Co., Ltd.

K-Number K223544

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GEX 2023-02-22

The Alma Soprano Titanium

Applicant Alma Lasers, Inc.

K-Number K230371

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