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 2022-05-26

Wearable Breast Pump (Model S9)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K220596

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LZA 2022-05-26

PP Care Nitrile Examination Gloves

Applicant Eg Group Product and Services Co., Ltd.

K-Number K212629

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NGX 2022-05-26

I-Motion

Applicant I-Motion Group Global Iberica S.L.

K-Number K212413

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JFJ 2022-05-26

Amylase2

Applicant Abbott Ireland Diagnostics Division

K-Number K210633

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FRA 2022-05-26

Aura Storm

Applicant Invictus Lighting

K-Number K212644

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DQD 2022-05-26

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

Applicant Chip Ideas Electronics S.L.

K-Number K211779

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KGO 2022-05-26

Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs

Applicant Hartalega NGC Sdn. Bhd.

K-Number K214074

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FXX 2022-05-26

Disposable Surgical Face Mask (FM-34EE,FM-44EE)

Applicant Qingdao Bestex Rubber & Plastic Products Co., Ltd.

K-Number K220597

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KGO 2022-05-25

Disposable Sterilized Latex Surgical Gloves

Applicant Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

K-Number K211953

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OLO 2022-05-25

Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K221180

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FMI 2022-05-25

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

Applicant W. L. Med Co., Ltd.

K-Number K210748

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FED 2022-05-25

Single Use Ureteral Access Sheath

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K220065

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