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

JXI 2024-06-21

Mochida Nerve Cuff

Applicant Mochida Pharmaceutical Co., Ltd.

K-Number K233322

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EIH 2024-06-21

rainbow Paste Stain SE

Applicant Genoss Co., Ltd.

K-Number K233885

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HQC 2024-06-21

UNITY VCS (8065000296); UNITY CS (8065000297)

Applicant Alcon Laboratories, Inc.

K-Number K233876

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ONB 2024-06-21

ToxiSeal Vial Adaptor with External Flip Balloon

Applicant Epic Medical Pte. , Ltd.

K-Number K241476

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QYT 2024-06-21

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test

Applicant CorDx, Inc.

K-Number K240728

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FRG 2024-06-21

Medicom Sterilization Wrap

Applicant Medicom Group, Inc.

K-Number K240862

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FAJ 2024-06-21

Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K240663

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DQA 2024-06-21

Pulse Oximeter (MD300C228)

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K232975

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QIH 2024-06-21

Medihub Prostate

Applicant JLK, Inc.

K-Number K233196

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SBQ 2024-06-21

Tempus ECG-AF

Applicant Tempus AI, Inc.

K-Number K233549

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DQX 2024-06-21

MINAMO blue; MINAMO viola

Applicant Asahi Intecc Co., Ltd.

K-Number K240387

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EWO 2024-06-21

OtoNova/OtoNova Pro

Applicant Otodynamics

K-Number K234095

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