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

HSD 2024-02-12

Univers Revers CA Head and Adapter

Applicant Arthrex, Inc.

K-Number K233260

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MLY 2024-02-12

PainFreeze II

Applicant Nuance Medical, LLC

K-Number K232674

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JXI 2024-02-12

NerveTape

Applicant Biocircuit Technologies, Inc.

K-Number K233533

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NUH 2024-02-12

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K-Number K233092

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NEU 2024-02-12

SCOUT MD Surgical Guidance System

Applicant Merit Medical System, Inc.

K-Number K231468

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HIH 2024-02-12

SPY Cystoscope/Hysteroscope

Applicant Stryker Endoscopy

K-Number K233635

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HSB 2024-02-12

I.T.S. INS Proximal Femur Nail

Applicant I.T.S. GmbH

K-Number K233134

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IYO 2024-02-12

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)

Applicant Eieling Technology Limited

K-Number K233401

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NFO 2024-02-12

Facial Toning device (UIC-189); Facial Toning device (UIC-589)

Applicant Body Trim Industrial Co., Ltd.

K-Number K233667

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LLZ 2024-02-12

Mimics Cardiac Planner

Applicant Materialise NV

K-Number K233217

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HIH 2024-02-12

Endoscopic Video Image Processor, Single-Use Video Hysteroscope

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K232003

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NUH 2024-02-12

EMS/TENS Massager Device

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K-Number K233040

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