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

HSB 2024-08-22

Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System

Applicant Tdm Co., Ltd.

K-Number K230071

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DXT 2024-08-22

Single-use Sterile High-pressure Angiographic Syringes and Accessories

Applicant Shenzhen Boon Medical Supply Co., Ltd.

K-Number K241109

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NFJ 2024-08-22

iCare ALTIUS CW

Applicant Centervue S.P.A.

K-Number K234076

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DYB 2024-08-22

Introducer Sheath Kits

Applicant Beijing Demax Medical Technology Co.,Ltd

K-Number K242248

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QOG 2024-08-22

INSULCLOCK® v2.0 PRO

Applicant Insulcloud S.L.

K-Number K241803

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FPA 2024-08-22

I.V. Administration Set

Applicant Bq Plus Medical Co., Ltd.

K-Number K242126

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MQC 2024-08-22

LIJIA Night Guard

Applicant Lijia, LLC

K-Number K241369

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FAJ 2024-08-22

LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)

Applicant Lina Medical Aps

K-Number K240227

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HSB 2024-08-22

Phantom Fibula Nail System

Applicant Paragon 28, Inc.

K-Number K234128

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QIH 2024-08-22

NeuroQuant

Applicant Cortechs Labs, Inc.

K-Number K241098

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IYN 2024-08-22

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

Applicant Beijing Konted Medical Technology Co.,Ltd

K-Number K241979

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JDS 2024-08-22

TRIGEN INTERTAN 10S Nail System

Applicant Smith & Nephew, Inc.

K-Number K241804

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