Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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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FJK 2023-05-31

CombiSet Hemodialysis Blood Tubing Set

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K213992

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LNH 2023-05-30

Sonic DL

Applicant Ge Medical Systems,Llc (Ge Healthcare)

K-Number K223523

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DSA 2023-05-30

RFP-100A Connector Cable (Single Use)

Applicant Baylis Medical Technologies, Inc.

K-Number K230571

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QQI 2023-05-30

PrecisionTAVI (v1.1)

Applicant Dasi Simulations

K-Number K223809

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LLZ 2023-05-30

Quicktome Software Suite

Applicant Omniscient Neurotechnology Pty Ltd (O8t)

K-Number K222359

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HRS 2023-05-30

Smith & Nephew ACCORD™ Cable System

Applicant Smith & Nephew

K-Number K223762

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