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

FMF 2026-06-18

Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

Applicant Sol-Millennium Medical, Inc.

K-Number K253110

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HGX 2026-06-18

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K254254

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OHS 2026-06-18

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)

Applicant Guangdong Newdermo Biotech Co., Ltd.

K-Number K260946

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JWO 2026-06-18

Blood Volume Analyzer (200)

Applicant Daxor Corporation

K-Number K261099

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FRO 2026-06-17

Bonvadis®

Applicant Oneness Biotech Co., Ltd.

K-Number K261638

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MRX 2026-06-17

Assisted Reproduction Laser System (Model ILS-400M)

Applicant Hua Yue Medical Technology Co., Ltd.

K-Number K253333

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NKB 2026-06-17

“Socko” Vimax Spinal Fixation System

Applicant Socko Medical Co., Ltd.

K-Number K253045

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ODG 2026-06-17

RIVOS™ EUS Access Device (M00553900)

Applicant Boston Scientific Corporation

K-Number K260428

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QFG 2026-06-17

twiist Automated Insulin Delivery (AID) System

Applicant Deka Research and Development

K-Number K261672

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MUI 2026-06-17

Non-Sterile Ultrasound Gel Sterile Ultrasound Gel

Applicant Foshan Pingchuang Medical Technology Co., Ltd.

K-Number K253255

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CAW 2026-06-17

Portable Oxygen Concentrator

Applicant Honsun (Nantong) Co., Ltd.

K-Number K252399

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GEX 2026-06-17

PICOSURE WORKSTATION

Applicant Cynosure, LLC

K-Number K261570

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