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

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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GYB 2021-12-01

AC Cream - Conductive paste

Applicant Spes Medica Srl

K-Number K212326

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MOS 2021-12-01

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K212864

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KCT 2021-11-30

InstruSafe Instrument Protection System

Applicant Summitt Medical, LLC

K-Number K210836

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FXX 2021-11-30

Disposable Surgical Face Mask

Applicant Anhui Cleanpro Pharmpack Co., Ltd.

K-Number K211696

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