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

PBX 2021-07-19

Evolve System with the T3 Applicator

Applicant InMode , Ltd.

K-Number K210877

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DXF 2021-07-19

Z-6 Atrioseptostomy Catheter

Applicant NuMED, Inc.

K-Number K211910

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LYZ 2021-07-17

Powder Free Vinyl Patient Examination Gloves

Applicant Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.

K-Number K211177

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LYZ 2021-07-17

Vinyl Patient Examination Gloves

Applicant Jiangxi Shengda Medical Technology Co., Ltd.

K-Number K211239

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PKC 2021-07-16

Ignite Stemless Anatomic Shoulder System

Applicant Ignite Orthopedics, LLC

K-Number K203108

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KLE 2021-07-16

PacBond One

Applicant Pac-Dent, Inc.

K-Number K210186

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GAM 2021-07-16

StitchKit

Applicant Origami Surgical Inc .

K-Number K211792

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PHL 2021-07-16

ExoAtlet-II

Applicant Exoatlet Asia Co. , Ltd.

K-Number K201473

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MQC 2021-07-16

JS Dental Lab Mouth Guard

Applicant Ampower Dental Laboratories, LLC

K-Number K210011

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KRA 2021-07-16

SwiftNINJA Steerable Microcatheter

Applicant Merit Medical Systems, Inc.

K-Number K211525

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FXX 2021-07-16

Velguard Surgical Face Mask

Applicant Esstee Exports Health Care Division

K-Number K210761

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GEI 2021-07-16

Soniquence Reusable Bipolar Cable

Applicant Soniquence, LLC

K-Number K211946

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