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

LHI 2022-04-24

IVX Fluid Transfer Set

Applicant Omnicell, Inc.

K-Number K212530

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GZJ 2022-04-23

TENS device-EmeTerm 2, Model: YF-ZTY-E2

Applicant Wat Medical Technology, Inc.

K-Number K220503

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INI 2022-04-22

Electric Scooter

Applicant Anhui Jbh Medical Apparatus Co., Ltd.

K-Number K212090

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LLZ 2022-04-22

MirrorMe3D Modeling System

Applicant Mirrorme3D, LLC

K-Number K212981

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FRO 2022-04-22

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K211123

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BTT 2022-04-22

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K212031

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KNT 2022-04-22

Avanos* CORTRAK* 2 Enteral Access System (EAS)

Applicant Avanos Medical, Inc.

K-Number K220588

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IYO 2022-04-22

ATUSA™ Automated 3D Breast Ultrasound System

Applicant Isono Health, Inc.

K-Number K213620

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OLO 2022-04-22

ROSA® Knee System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K213708

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GAQ 2022-04-22

CoNextions TR Tendon Repair System

Applicant Conextions Medical

K-Number K203855

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FTC 2022-04-22

1 Series Phototherapy Equipment

Applicant Daavlin Distributing Co.

K-Number K220840

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MSC 2022-04-22

Lorals

Applicant Brazen Goods Inc. Dba Lorals

K-Number K212928

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