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

JDB 2022-10-26

TEMA Elbow system - Line extension

Applicant Lima Corporate S.P.A.

K-Number K222807

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KPR 2022-10-26

DigiX FDX

Applicant Allengers Medical Systems Limited

K-Number K223060

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FRO 2022-10-26

Silverlon Wound Contact, Burn Contact Dressings

Applicant Argentum Medical, Inc.

K-Number K221218

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IWB 2022-10-26

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)

Applicant Elekta Solutions AB

K-Number K222047

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LYY 2022-10-26

Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)

Applicant Hebei Titans Hongsen Medical Technology Co., Ltd.

K-Number K221374

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DQX 2022-10-26

VASSALLO GT EXT

Applicant Filmecc Co., Ltd.

K-Number K222631

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QDJ 2022-10-26

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

Applicant 23AndMe, Inc.

K-Number K221885

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NHA 2022-10-26

Preat Abutments

Applicant Preat Corporation

K-Number K220823

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GEI 2022-10-26

NEUROMARK System

Applicant Neurent Medical

K-Number K222032

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EHD 2022-10-26

EzRay Air 2 Wall (Model: VEX-S350W)

Applicant VATECH Co., Ltd.

K-Number K223058

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EOX 2022-10-26

EsoCheck Cell Collection Device

Applicant Lucid Diagnostics, Inc.

K-Number K222366

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JKA 2022-10-26

Eclipse Blood Collection Set

Applicant Eclipse Medcorp, LLC

K-Number K213690

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