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

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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QNL 2024-06-21

eCARTv5 Clinical Deterioration Suite (“eCART”)

Applicant Agilemd, Inc.

K-Number K233253

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FXX 2024-06-21

Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)

Applicant Owens & Minor (O&M) Halyard, Inc.

K-Number K232807

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ODE 2024-06-21

GERDX-System

Applicant G-Surg GmbH

K-Number K233240

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