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

PCH 2025-01-08

QIAstat-Dx GI Panel 2 Mini B&V

Applicant QIAGEN GmbH

K-Number K243813

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LZA 2025-01-08

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K243818

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MNR 2025-01-08

DormoTech NLab

Applicant Dormotech Medical, Ltd.

K-Number K242290

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MQL 2025-01-08

Sperm Freezing Medium

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K-Number K242043

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MSX 2025-01-08

ANNE View, Central Hub

Applicant Sibel Health, Inc.

K-Number K242842

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FMI 2025-01-08

ACE Cannula

Applicant Ace Medical Industry Co., Ltd.

K-Number K242741

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JFB 2025-01-08

Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)

Applicant Ceragem Co., Ltd.

K-Number K243644

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DZE 2025-01-08

TRI-matrix® X-Force Implants

Applicant Tri Dental Implants Int. AG

K-Number K242661

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QOF 2025-01-08

Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel

Applicant Life Technologies Corporation

K-Number K241806

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INI 2025-01-08

Electrical Scooter, WT-T4SU

Applicant W'U'S Tech Co., Ltd.

K-Number K240590

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NHA 2025-01-08

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

Applicant Hiossen, Inc.

K-Number K241003

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LBH 2025-01-08

ReminGel

Applicant Inter-Med, Inc.

K-Number K241489

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