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

LLZ 2025-08-29

SurgiTwin

Applicant Twinsight

K-Number K250290

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GEX 2025-08-29

GLAM LED Facial Mask (TB-2386F)

Applicant Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.

K-Number K251727

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KPI 2025-08-29

Regenesis EMS Chair

Applicant Trinity Medical Solutions

K-Number K251026

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NAY 2025-08-29

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K251324

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HET 2025-08-29

SIRIUS Endoscope System (PR-SI-1230)

Applicant Precision Robotics (Hong Kong) Limited

K-Number K250939

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ODP 2025-08-29

IVA & AEON Cervical and Lumbar Cage System

Applicant K&J Consulting

K-Number K250335

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KPR 2025-08-28

Definium Tempo Select

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K250788

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QEW 2025-08-28

Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System

Applicant Imperative Care, Inc.

K-Number K252057

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NGX 2025-08-28

truFlex

Applicant Syrma Johari Medtech Limited

K-Number K251594

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QOG 2025-08-28

SmartPilot YpsoMate NS-A2.25

Applicant Ypsomed AG

K-Number K243901

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MNR 2025-08-28

Somfit D

Applicant Compumedics Limited

K-Number K252383

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LYZ 2025-08-28

Powder-Free Vinyl Exam Gloves, clear

Applicant Basic Medical Technology, Inc.

K-Number K252505

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