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

ERL 2022-01-19

Celeris, Disposable Sinus Debrider

Applicant Gyrus Acmi, Inc.

K-Number K212650

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JDQ 2022-01-19

Stern Fix Sternal Stabilization System

Applicant Neos Surgery S.L

K-Number K211613

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DXN 2022-01-19

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33

Applicant Yibin Junxin Electronics Technology Co., Ltd.

K-Number K211532

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QIH 2022-01-19

Follicle Clarity

Applicant Cycle Clarity

K-Number K212012

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OLO 2022-01-19

CoreLink Navigation Instruments

Applicant Corelink, LLC

K-Number K214059

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PMN 2022-01-19

MDx-Chex for BCID2

Applicant Streck, Inc.

K-Number K212576

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PKC 2022-01-19

GLOBAL ICON Stemless Shoulder System

Applicant Depuy(Ireland)

K-Number K212683

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MBH 2022-01-18

ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP

Applicant Depuy Ireland UC

K-Number K213781

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FMF 2022-01-18

CHIRANA Insulin Syringes

Applicant Chirana T. Injecta

K-Number K201044

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LPL 2022-01-18

Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens

Applicant Unicon Optical Co., Ltd.

K-Number K213216

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IRP 2022-01-18

Air compression leg massager HY-1117A

Applicant Xiamen High Top Electronic Technology Co., Ltd.

K-Number K212713

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HWC 2022-01-18

JuniOrtho Plating System™

Applicant Orthofix Srl

K-Number K213572

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