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

NRY 2025-01-14

Zoom System

Applicant Imperative Care, Inc.

K-Number K242672

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LLZ 2025-01-14

SpectoMed (v1.0)

Applicant Specto Medical

K-Number K242205

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DXN 2025-01-14

BB-613-BPM

Applicant Biobeat Technologies , Ltd.

K-Number K241066

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OXO 2025-01-14

Orthoscan VERSA Mini C-Arm

Applicant Ziehm-Orthoscan, Inc.

K-Number K243452

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SCA 2025-01-13

QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

Applicant Osang, LLC

K-Number K243262

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JAK 2025-01-13

SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

Applicant Arineta , Ltd.

K-Number K241200

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NHA 2025-01-13

MegaGen Dental Implant Abutment

Applicant Megagen Implant Co., Ltd.

K-Number K242030

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MRD 2025-01-13

MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

Applicant Mentor Worldwide, LLC

K-Number K243271

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IRP 2025-01-13

Air Pressure Therapy System

Applicant Xiamen Weiyou Intelligent Technology Co., Ltd.

K-Number K243791

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HSB 2025-01-13

Arthrex Intramedullary Nails

Applicant Arthrex, Inc.

K-Number K243890

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FMK 2025-01-13

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

Applicant Hlb Co., Ltd. Healthcare

K-Number K243533

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JWH 2025-01-13

Initia Knee System

Applicant Kyocera Medical Technologies, Inc.

K-Number K243295

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