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

DXN 2026-04-01

Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K260276

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EZD 2026-04-01

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

Applicant Convatec Limited

K-Number K252943

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NUC 2026-04-01

Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)

Applicant Hudi Pharma Srl

K-Number K260007

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SHN 2026-04-01

Medical Imaging Calibration Feature (MICF)

Applicant Apple, Inc.

K-Number K253582

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DQK 2026-04-01

Synchrony

Applicant Stereotaxis, Inc.

K-Number K253473

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DXN 2026-04-01

Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)

Applicant Shenzhen HanHan Technology Co., Ltd.

K-Number K254225

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OAS 2026-03-31

Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)

Applicant VATECH Co., Ltd.

K-Number K260093

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LLZ 2026-03-31

RW-1

Applicant Mediott, Inc.

K-Number K253029

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FBK 2026-03-31

InjecSURE Injection System

Applicant Carbon Medical Technologies, Inc.

K-Number K253598

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IOR 2026-03-31

K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K260319

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GEX 2026-03-31

Nd: YAG Laser Therapy Systems

Applicant Sanhe Meditech Co., Ltd.

K-Number K260375

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FMK 2026-03-31

Safety lancet (XXXVII)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K260191

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