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

LZA 2022-01-03

Disposable Nitrile Medical Powder-free Glove

Applicant Fujian Chunhui Medical Supply Co., Ltd.

K-Number K213187

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KCT 2022-01-02

Sterisystem Dry-Base Instrument Tray

Applicant O&M Halyard, Inc.

K-Number K203177

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OMP 2021-12-30

Tzoar 207 Negative Pressure Wound Therapy (NPWT) System

Applicant Lightstone Medical Products (Ningbo) Co, Ltd.

K-Number K202898

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HQD 2021-12-30

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K-Number K213538

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NUH 2021-12-30

Intrelief

Applicant Easymed Instruments Co., Ltd.

K-Number K211263

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HWC 2021-12-30

Quick-Start Screws

Applicant Innovate Orthopaedics Limited

K-Number K212547

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GDW 2021-12-30

Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers

Applicant Ningbo Verykind Medical Device Co., Ltd.

K-Number K211458

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LZA 2021-12-30

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)

Applicant Siyang Threeguard Medical Supplies Co., Ltd.

K-Number K212834

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OAS 2021-12-30

eco-x Series (eco-x, eco-x-s)

Applicant Hdx Will Corp.

K-Number K211159

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PCS 2021-12-29

LiverSmart

Applicant Resonance Health Analysis Services Pty, Ltd.

K-Number K213776

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EOQ 2021-12-29

Flexible Intubation Video Endoscope – Sterile (FIVE-S)

Applicant Karl Storz Endoscopy America

K-Number K212656

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KOI 2021-12-29

Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM

Applicant Nihon Kohden Corporation

K-Number K213316

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