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

NXC 2025-01-16

Pearl Clear Aligner

Applicant Pearl Digital, Inc.

K-Number K242715

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DPS 2025-01-16

CloudHRV System (100-01-001)

Applicant Inmedix, Inc.

K-Number K241217

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NBC 2025-01-16

Alere NT-proBNP for Alinity i Reagent Kit

Applicant Axis-Shield Diagnostics, Ltd.

K-Number K241176

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EOQ 2025-01-16

Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K242416

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QEP 2025-01-16

cobas® liat CT/NG/MG nucleic acid test

Applicant Roche Molecular Systems, Inc.

K-Number K240197

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NGX 2025-01-16

Pepper EMS Training System

Applicant Pepper Interactive, Inc.

K-Number K233770

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QGL 2025-01-16

ADDNOX (BPSPM1)

Applicant Nu Eyne Co., Ltd.

K-Number K243289

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SCA 2025-01-16

WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest

Applicant Wondfo USA Co, Ltd.

K-Number K243256

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MYN 2025-01-16

Second Opinion CC

Applicant Pearl, Inc.

K-Number K242522

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KCT 2025-01-16

System 9 Sterile Battery Container

Applicant Stryker Instruments

K-Number K242834

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PCH 2025-01-16

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

Applicant Biofire Diagnostics, LLC

K-Number K243885

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MUE 2025-01-16

VIVIX-M

Applicant Vieworks Co., Ltd.

K-Number K241113

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