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

EHD 2024-05-13

REMEX-GR100

Applicant Remedi Co., Ltd.

K-Number K240759

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LLZ 2024-05-13

MIM – Monte Carlo Dosimetry

Applicant Mim Software, Inc.

K-Number K232862

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LZA 2024-05-13

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)

Applicant Sri Trang Gloves (Thailand) Public Company Limited

K-Number K232614

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PKT 2024-05-13

1060nm laser body slimming machine

Applicant Hebei JT Medical Co., Ltd.

K-Number K240658

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NGL 2024-05-13

Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

Applicant Healgen Scientific,, LLC

K-Number K240949

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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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