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

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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LLZ 2021-11-08

GIQuant

Applicant Motilent, Ltd.

K-Number K211356

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DWF 2021-11-08

Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F

Applicant Qura S.R.L

K-Number K203067

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NBC 2021-11-08

ST AIA-PACK BNP Assay

Applicant Tosoh Bioscience, Inc.

K-Number K211199

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LZA 2021-11-07

Medical Examination Gloves (Tested for Use with Chemotherapy)

Applicant Guangdong Gymda Medical Technology Co.,Ltd

K-Number K212506

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FYC 2021-11-07

Isolation Gown AAMI Level 3

Applicant Kenpax International Limited

K-Number K212504

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FXX 2021-11-05

Disposable Medical Face Mask

Applicant Zhejiang Senhong Medical&Instrument Co., Ltd.

K-Number K202676

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GEX 2021-11-05

Resonic Rapid Acoustic Pulse Device

Applicant Soliton, Inc.

K-Number K212502

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