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 2023-04-27

ArtiSential Laparoscopic Instruments-Electrodes

Applicant Livsmed, Inc.

K-Number K230539

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ELW 2023-04-27

DentMix VPS Impression Material

Applicant Innovative Product Brands, Inc.

K-Number K223892

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GEI 2023-04-27

Renuvion® APR Handpiece

Applicant Apyx Medical Corporation

K-Number K230272

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MYE 2023-04-27

Gastric Alimetry System

Applicant Alimetry , Ltd.

K-Number K223398

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FET 2023-04-26

EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100

Applicant Olympus Medical Systems Corporation

K-Number K222584

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NUH 2023-04-26

TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K-Number K230829

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MAX 2023-04-26

PYXIS 3D Titanium Cage System

Applicant GS Medical Co., Ltd.

K-Number K223868

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GEI 2023-04-26

ArtiSential Laparoscopic Instruments-Electrodes

Applicant Livsmed, Inc.

K-Number K230499

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PTF 2023-04-26

Access PCT

Applicant Beckman Coulter, Inc.

K-Number K222996

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GEI 2023-04-26

SafeAir combi (SFR-combi-US)

Applicant Lina Medical Aps

K-Number K223932

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LLZ 2023-04-26

MR DWI/FLAIR Measurement V1.0

Applicant Olea Medical

K-Number K230552

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MXD 2023-04-26

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application

Applicant Medtronic, Inc.

K-Number K230553

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