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

FXX 2021-12-02

Puravita Medical Fold Flat Surgical Mask

Applicant Puravita M, LLC

K-Number K212740

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NYL 2021-12-02

PS System

Applicant Inter-Med, Inc.

K-Number K211721

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LZA 2021-12-02

powder free nitrile examination glove - white, non-sterile

Applicant Hong Seng Gloves Sdn Bhd

K-Number K212802

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GEI 2021-12-02

AURORA Evacuator +Coag

Applicant Rebound Therapeutics

K-Number K203745

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GEX 2021-12-02

OxyLight 2.0

Applicant Raja Trading Company, Inc.

K-Number K202175

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LZA 2021-12-01

Powder free nitrile examination glove- blue, non-sterile

Applicant Hong Seng Gloves Sdn Bhd

K-Number K212804

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HDX 2021-12-01

Milli Vaginal Dilator

Applicant Materna Medical

K-Number K211959

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KNS 2021-12-01

Sphincterotome / short-wire compatible, Sterile Sphincterotome

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K210934

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LZA 2021-12-01

Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

Applicant 5r Med Instruments (Chengdu) Co., Ltd.

K-Number K212789

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HGX 2021-12-01

Electric Breast Pump

Applicant Zhejiang Carebao Co., Ltd.

K-Number K211755

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MAX 2021-12-01

NGM WAVE PLIF Cage

Applicant NGMedical GmbH

K-Number K212050

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LNH 2021-12-01

Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K213305

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