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

KTT 2026-06-11

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

Applicant Synthes (USA) Products, LLC

K-Number K254087

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HGX 2026-06-11

AViTA Breast Pump

Applicant Avita Corporation

K-Number K250129

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GCJ 2026-06-10

“Tech-Image” Video Endoscope System

Applicant Tech-Image CO., LTD.

K-Number K260414

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MSS 2026-06-10

RxSight® Insertion Device

Applicant Rxsight, Inc.

K-Number K261174

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FMI 2026-06-10

Profoject™ Safety Pen Needles

Applicant CMT Health PTE., Ltd.

K-Number K260855

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IRP 2026-06-10

Cryo And Thermo Therapy System

Applicant Xiamen Weiyou Intelligent Technology Co., Ltd.

K-Number K253919

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DQK 2026-06-10

Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)

Applicant Centerline Biomedical

K-Number K261329

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HTN 2026-06-10

LARS ACJ

Applicant Movmedix S.A.S.

K-Number K253115

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PHX 2026-06-10

MSS - Humeral reverse liners extension

Applicant Medacta International, SA

K-Number K261016

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SIH 2026-06-10

Colli-Pee•Dx Urine Collection Kit

Applicant DNA Genotek, Inc.

K-Number K254121

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KLW 2026-06-10

Tinnitus Therapy

Applicant Sivantos GmbH

K-Number K260614

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OVD 2026-06-10

Anteralign LS coverplate

Applicant Tyber Medical, LLC

K-Number K260810

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