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

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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PZR 2021-11-05

Drug Relief v1

Applicant Dyansys, Inc.

K-Number K211971

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LYY 2021-11-05

Best Glove-Latex Powder Free Examination Glove

Applicant Bestsafe Glove Co., Ltd.

K-Number K210253

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GZI 2021-11-05

MStim Drop Model: LGT-233

Applicant Guangzhou Longest Science & Technology Co., Ltd.

K-Number K202110

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OWB 2021-11-05

VFSS Pro Mobile Digital Imaging System

Applicant Imagexray, LLC

K-Number K212523

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GCJ 2021-11-05

SoftFix Balloon Trocar

Applicant Unimax Medical Systems, Inc.

K-Number K211577

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