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

FRN 2023-08-24

Plum Duo™ Infusion System

Applicant Icu Medical, Inc.

K-Number K223607

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MSX 2023-08-24

Current Health System

Applicant Current Health , Ltd.

K-Number K231506

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HRS 2023-08-24

APS Metal Plate & Screw System

Applicant A Plus Biotechnology Co., Ltd.

K-Number K223150

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PHC 2023-08-24

LifeShield™ Infusion Safety Software Suite

Applicant Icu Medical, Inc.

K-Number K223606

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DZL 2023-08-24

Stryker MP, Mandible, HMMF and MMF AXS Screws

Applicant Stryker Leibinger GmbH & Co KG

K-Number K231599

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JDQ 2023-08-24

Arthrex Radiopaque FiberTape Cerclage sutures

Applicant Arthrex, Inc.

K-Number K230976

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LZA 2023-08-24

Nitrile Patient Examination Gloves, Powder Free, Pink Color

Applicant Shandong Yinghng Medical Products Co., Ltd.

K-Number K222103

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KCT 2023-08-24

Instrument Case

Applicant Cochlear Americas

K-Number K231604

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EFB 2023-08-23

EVO 700 series high speed handpiece

Applicant Ttbio Corp.

K-Number K232243

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FYA 2023-08-23

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

Applicant Dongguan Shin YI Healthcare Products Factory

K-Number K230610

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DPS 2023-08-23

Withings Scan Monitor 2.0

Applicant Withings

K-Number K230812

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CGN 2023-08-23

Access Folate Assay

Applicant Beckman Coulter, Inc.

K-Number K223590

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