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

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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ONF 2024-08-21

MULA (K2-A1)

Applicant Guangzhou Ciellulu Photoelectric Technology Co., Ltd.

K-Number K240314

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LLZ 2024-08-21

AiMIFY (1.x)

Applicant Subtle Medical, Inc.

K-Number K240290

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OUR 2024-08-21

TiLink-P SI Joint Fusion System

Applicant SurGenTec, LLC

K-Number K242141

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NDC 2024-08-21

iSage Rx

Applicant Amalgam Rx, Inc.

K-Number K242066

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DXN 2024-08-21

Blood Pressure Monitor (TMB-2092-G)

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K241351

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