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

SDD 2026-06-11

Dexter L6 System

Applicant Distalmotion SA

K-Number K260653

View Details →

OAS 2026-06-11

Dental X-ray System

Applicant Changzhou Boen Zhongding Medical Technology Co., Ltd.

K-Number K250839

View Details →

EIH 2026-06-11

Rosetta SM, Rosetta SP

Applicant Hass Corp.

K-Number K260859

View Details →

IOR 2026-06-11

ICON 35; ICON 45; ICON 60; ICON 30FAF

Applicant Rehasense USA, Inc.

K-Number K260849

View Details →

KTT 2026-06-11

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

Applicant Synthes (USA) Products, LLC

K-Number K254087

View Details →

HGX 2026-06-11

AViTA Breast Pump

Applicant Avita Corporation

K-Number K250129

View Details →

GCJ 2026-06-10

“Tech-Image” Video Endoscope System

Applicant Tech-Image CO., LTD.

K-Number K260414

View Details →

MSS 2026-06-10

RxSight® Insertion Device

Applicant Rxsight, Inc.

K-Number K261174

View Details →

FMI 2026-06-10

Profoject™ Safety Pen Needles

Applicant CMT Health PTE., Ltd.

K-Number K260855

View Details →

IRP 2026-06-10

Cryo And Thermo Therapy System

Applicant Xiamen Weiyou Intelligent Technology Co., Ltd.

K-Number K253919

View Details →

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

View Details →

HTN 2026-06-10

LARS ACJ

Applicant Movmedix S.A.S.

K-Number K253115

View Details →

Page 52 of 2728

↑