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

LAZ 2021-09-23

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

Applicant Changzhou Universal Medical Equipment Co., Ltd.

K-Number K211667

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DZE 2021-09-23

ABC Dental Implant System

Applicant Abracadabra Implants , Ltd.

K-Number K202092

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EBF 2021-09-22

ACTIVA PRESTO PACK

Applicant Pulpdent Corporation

K-Number K210045

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EOQ 2021-09-22

Single Use Guide Sheath Kit-401, K-402

Applicant Olympus Medical Systems Corp.

K-Number K212667

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FXX 2021-09-22

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)

Applicant Vr Vertical, LLC Dba Xrgo

K-Number K210772

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LZO 2021-09-22

Mpres Neck Preserving Stem

Applicant Medacta International S.A.

K-Number K210263

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MQV 2021-09-22

DB-EZ Bone Void Filler

Applicant Dimensional Bioceramics, LLC

K-Number K212353

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ITI 2021-09-22

Electric Wheelchair (XW-LY001)

Applicant Yongkang Dingchang Industry & Trade Co., Ltd.

K-Number K200423

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DXH 2021-09-22

SimpleSENSE Platform

Applicant Nanowear, Inc.

K-Number K212160

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QDP 2021-09-22

FilmArray Pneumonia Panel

Applicant Biofire Diagnostics, LLC

K-Number K212727

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NXC 2021-09-22

Smylio Invisible Clear Aligners

Applicant Smylio, Inc.

K-Number K212660

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FXX 2021-09-22

Banyan USA Surgical Mask Level 3

Applicant Banyan USA, LLC

K-Number K211097

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