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

FRN 2021-11-09

FreedomEdge(R) Syringe Infusion System

Applicant Repro-Medical System, Inc., Dba Koru Medical Systems

K-Number K211206

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GXY 2021-11-09

Comby EEG Caps

Applicant Pamel D.O.O

K-Number K211315

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HWC 2021-11-09

BESPA Charcot System

Applicant Bespa Global, LLC

K-Number K202326

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GEX 2021-11-09

Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories

Applicant Convergent Laser Technologies

K-Number K211517

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FXX 2021-11-09

Medical Face Masks, Model Name:MY020003

Applicant Huizhou Jie Bai Purification Co., Ltd.

K-Number K211165

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FXX 2021-11-09

Surgical Face Mask

Applicant Suzhou Janee Medical Technology Co., Ltd.

K-Number K212526

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EFB 2021-11-08

Highspeed Airturbine Handpiece

Applicant Beijing Dongbo Dental Handpiece Co., Ltd.

K-Number K202371

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KCT 2021-11-08

Biotech Dental Kits

Applicant Biotech Dental, Sas

K-Number K212068

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KTT 2021-11-08

Paragon 28 External Ring Fixation System

Applicant Paragon 28, Inc.

K-Number K212895

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GYB 2021-11-08

GT5 conductive & abrasive gel

Applicant Wuhan Greentek Pty , Ltd.

K-Number K212787

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OWB 2021-11-08

FDR Cross (DR-XD 3000)

Applicant Fujifilm Corporation

K-Number K212956

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LLZ 2021-11-08

Hura CTP v1.0

Applicant Hura Imaging, Inc.

K-Number K212550

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