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

SCV 2024-10-11

Versius Surgical System

Applicant Cmr Surgical Limited

K-Number DEN230078

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JSM 2024-10-11

UriSponge

Applicant Copan Italia Spa

K-Number K232565

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NLH 2024-10-11

Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter

Applicant Sterilmed, Inc.

K-Number K240826

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FDS 2024-10-11

Hood (DH-083ST)

Applicant Fujifilm Corporation

K-Number K242779

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LCX 2024-10-11

HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

Applicant Anhui Deepblue Medical Technology Co., Ltd.

K-Number K240242

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DQA 2024-10-11

Belun Ring BLR-200 (BLR-200)

Applicant Belun Technology Company Limited

K-Number K234110

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JOW 2024-10-11

ARTAIRA Arterial Compression Device (AACD01)

Applicant Airos Medical, Inc.

K-Number K240499

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OMC 2024-10-11

QUEX ED; QUEX S

Applicant Qx World, Ltd.

K-Number K232779

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GEX 2024-10-11

Accure Laser System

Applicant Accure Acne, Inc.

K-Number K242035

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QBD 2024-10-11

PPH Saliva Collection Kit

Applicant Permantis Public Health

K-Number K240797

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OAP 2024-10-11

PBM Hair Therapy Cap

Applicant Dongguan Tutamen Metalwork Co., Ltd.

K-Number K240472

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IYN 2024-10-11

HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K241971

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