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

JKA 2023-06-01

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)

Applicant Sb-Kawasumi Laboratories, Inc.

K-Number K230408

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GEX 2023-06-01

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)

Applicant Candela Corporation

K-Number K230990

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JTN 2023-06-01

HardyDisk AST Rezafungin 5µg (RZF5)

Applicant Hardy Diagnostics

K-Number K230827

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JAK 2023-06-01

OmniTom Elite

Applicant Neurologica Corporation, A Subsidiary of Samsung

K-Number K223447

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LLZ 2023-06-01

Brainomix 360 e-CTP

Applicant Brainomix Limited

K-Number K223555

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MBI 2023-06-01

FiberTak® Suture Anchor

Applicant Arthrex, Inc.

K-Number K231330

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DQO 2023-06-01

Drakon and Sequre® Microcatheters

Applicant Accurate Medical Therapeutics

K-Number K231293

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MHX 2023-06-01

Radius VSM and Accessories

Applicant Masimo Corporation

K-Number K223498

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QQX 2023-06-01

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

Applicant Roche Molecular Systems, Inc.

K-Number K231306

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EOQ 2023-06-01

Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance

Applicant Ambu A/S

K-Number K223299

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FXX 2023-06-01

Surgical Face Mask (L 175*95mm)

Applicant Henan Chaoya Medical Equipment Co., Ltd.

K-Number K230617

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QEW 2023-06-01

Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)

Applicant Innova Vascular, Inc.

K-Number K223929

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