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

NFO 2024-05-13

BEAR 2 Body

Applicant Foreo, Inc.

K-Number K232242

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FPA 2024-05-10

Disposable infusion set with needle

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K232475

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NEZ 2024-05-10

PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software

Applicant Given Imaging Ltd. (D.B.A. Medtronic)

K-Number K240276

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MQL 2024-05-10

Oocyte Flushing & Retrieval Medium; Gamete Buffer

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K-Number K234023

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FPB 2024-05-10

Filter Needle for Single Use

Applicant Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

K-Number K233277

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LTK 2024-05-10

Access OV Monitor

Applicant Beckman Coulter, Inc.

K-Number K240479

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KPO 2024-05-10

pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K233950

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CAF 2024-05-10

Aerogen®Solo Nebulizer System

Applicant Aerogen, Ltd.

K-Number K232507

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QOF 2024-05-10

QIAstat-Dx® Respiratory Panel Plus

Applicant QIAGEN GmbH

K-Number K233100

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FGB 2024-05-10

Ureterorenoscope System

Applicant Shenzhen HugeMed Medical Technical Development Co., Ltd.

K-Number K240374

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DJG 2024-05-10

Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K-Number K240698

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GAT 2024-05-10

HyperSuture Extension Line

Applicant Threadstone, LLC

K-Number K234079

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