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

IRP 2024-10-08

Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)

Applicant Sichuan Qianii-Beoka Medical Technoiogy Lnc.

K-Number K241446

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ILK 2024-10-07

GENESIS (MS-P02-GEN)

Applicant Climbing Steps, Inc.

K-Number K240843

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HSX 2024-10-07

OvertureTi Knee Resurfacing SystemTM

Applicant Overture Orthopaedics

K-Number K242746

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MEB 2024-10-07

SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

Applicant Epic Medical Pte. , Ltd.

K-Number K242152

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FRO 2024-10-07

LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K240485

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IYN 2024-10-07

EPIQ Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K240980

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LDR 2024-10-07

DEKA Infusion System, DEKA Administration Set

Applicant Deka Research and Development Corporation

K-Number K242693

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IYO 2024-10-07

SpineUs System

Applicant Verdure Imaging

K-Number K241029

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LPH 2024-10-07

OR3O Dual Mobility System

Applicant Smith & Nephew, Inc.

K-Number K242375

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OCX 2024-10-07

Water Container (MAJ-901); Water Container (MAJ-902)

Applicant Olympus Medical Systems Corporation

K-Number K242357

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FRG 2024-10-07

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Applicant Primed Medical Products, Inc.

K-Number K242208

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SCA 2024-10-07

Healgen Rapid Check COVID-19/Flu A&B Antigen Test

Applicant Healgen

K-Number DEN240029

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