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

HGX 2021-08-26

TT Electric Breast Pump, TT Double Electric Breast Pump

Applicant Wuxi Xinzhongrui Baby Supplies Co., Ltd.

K-Number K202802

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FMF 2021-08-26

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle

Applicant Guangdong Antmed Co., Ltd.

K-Number K210991

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QEP 2021-08-26

Visby Medical Sexual Health

Applicant Visby Medical

K-Number K200748

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BTM 2021-08-26

Disposable Manual Resuscitator

Applicant Xiamen Compower Medical Tech. Co., Ltd.

K-Number K210288

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ETN 2021-08-26

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large

Applicant Checkpoint Surgical

K-Number K212355

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DQY 2021-08-26

ViperCross Support Catheters

Applicant Cardiovascular Systems, Inc.

K-Number K211240

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OXZ 2021-08-26

The iMask Child's Face Mask

Applicant Pac-Dent, Inc.

K-Number K202831

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FMK 2021-08-26

Heel Incision Safety Lancet

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K210745

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MVM 2021-08-26

Aptiva Celiac Disease IgG Reagent

Applicant Inova Diagnostics, Inc.

K-Number K200230

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FYC 2021-08-26

ComfortGuard Surgical Isolation Gown

Applicant Gri-Alleset, Inc.

K-Number K210131

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LZA 2021-08-26

Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)

Applicant Tangshan Lanhai Medical Supplies Co., Ltd.

K-Number K210898

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FMI 2021-08-26

Hypodermic Needle-Pro EDGE Safety Device

Applicant Smiths Medical Asd, Inc.

K-Number K211634

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