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

OWB 2023-06-01

ANT-X System

Applicant Ndr Medical Technology Pte. , Ltd.

K-Number K230185

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MMK 2023-06-01

Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)

Applicant Ningbo Maxcon Medical Technology Co., Ltd.

K-Number K222905

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GEI 2023-05-31

BTL-785X

Applicant BTL Industries, Inc.

K-Number K222556

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QNQ 2023-05-31

FEELject LDV (Low dead volume) syringe

Applicant Feeltech Co., Ltd.

K-Number K213010

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NLH 2023-05-31

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K221067

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MAI 2023-05-31

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)

Applicant Osteonic Co., Ltd.

K-Number K231326

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LZA 2023-05-31

Disposable Nitrile Gloves (ABC-DG01)

Applicant Huizhou Anboson Technology Co., Ltd.

K-Number K230542

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KIF 2023-05-31

iRoot SP Plus

Applicant Innovative Bioceramix, Inc.

K-Number K231259

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CBK 2023-05-31

Nihon Kohden NKV-440 Ventilator System

Applicant Nihon Kohden Orangemed, Inc.

K-Number K222644

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FTL 2023-05-31

Pitch PaSoft Tissue Reinforcement Device

Applicant Xiros, Ltd.

K-Number K230671

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LPL 2023-05-31

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

Applicant Pegavision Corporation

K-Number K222885

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CAW 2023-05-31

Oxus Sieve Beds

Applicant Oxus, Inc.

K-Number K211056

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