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

KNT 2021-11-17

Qora Stool Management Kit

Applicant Cm Technologies, Inc.

K-Number K212444

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EIH 2021-11-17

BruxZir Esthetic

Applicant Prismatik Dentalcraft, Inc.

K-Number K213425

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OWB 2021-11-17

Soteria.AI

Applicant Omega Medical Imaging, LLC

K-Number K212336

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PIF 2021-11-16

Enteral Feeding Set

Applicant Kb Medical (Group), Inc.

K-Number K210854

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HWC 2021-11-16

Sterile PHALINX Hammertoe System

Applicant Wrightmedicaltechnologyinc

K-Number K212996

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QRA 2021-11-16

EaseVRx

Applicant Appliedvr, Inc.

K-Number DEN210014

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LZA 2021-11-16

Disposable Medical Nitrile Examination Gloves (non-sterile)

Applicant Taizhou Kangjian Medical Equipments Co., Ltd.

K-Number K212029

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CAH 2021-11-16

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger

Applicant Pall Corporation

K-Number K211286

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MAX 2021-11-16

Deploy Expandable Interbody System

Applicant Southern Spine, LLC

K-Number K211845

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MCW 2021-11-16

Pantheris System

Applicant Avinger, Inc.

K-Number K212047

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HCG 2021-11-16

InZone Detachment System

Applicant Stryker Neurovascular

K-Number K212455

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JWH 2021-11-16

Opulent TiNbN Coated Knee

Applicant Meril Healthcare Pvt. , Ltd.

K-Number K212839

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