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

FMI 2024-09-26

Verifine® Pen Needles

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K242632

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HRS 2024-09-26

Protean Fragment Plating System

Applicant Skeletal Dynamics, Inc.

K-Number K241815

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EBF 2024-09-26

Any-Com

Applicant Mediclus Co., Ltd.

K-Number K241147

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GXP 2024-09-26

Permatage Settable Bone Putty

Applicant Orthocon, Inc.

K-Number K241027

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HSB 2024-09-26

Affixus Tibial and Antegrade Femoral Nailing System

Applicant Zimmer, Inc.

K-Number K241651

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MQK 2024-09-26

cryo-GO Vitrification Device

Applicant Fujifilm Irvine Scientific

K-Number K241341

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SCY 2024-09-26

Cannulated PsiFGuard

Applicant Spineguard

K-Number K241895

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NEU 2024-09-26

MOLLI 2 System

Applicant Molli Surgical, Inc.

K-Number K234149

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BZD 2024-09-26

myAir

Applicant Resmed Corp

K-Number K241216

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NEY 2024-09-26

Microwave Ablation Generator (KY-2000A, KY-2100A)

Applicant Canyon Medical, Inc.

K-Number K241827

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DXF 2024-09-26

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)

Applicant Circa Scientific, Inc.

K-Number K241414

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QNJ 2024-09-26

Accelerate Arc System

Applicant Accelerate Diagnostics, Inc.

K-Number K240854

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