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

LFL 2023-02-28

HARMONIC 700 Shears

Applicant Ethicon Endo-Surgery, LLC

K-Number K221790

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DXC 2023-02-28

VIOLA

Applicant Vascular Graft Solutions, Ltd.

K-Number K230248

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HWC 2023-02-28

REVCON (TM) Screw System

Applicant Voom Medical Devices, Inc.

K-Number K223392

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QAU 2023-02-28

PuraStat

Applicant 3-D Matrix, Inc.

K-Number K222481

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FRC 2023-02-28

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

Applicant Terragene S.A.

K-Number K221641

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QHA 2023-02-28

AccuICAS

Applicant ArteryFlow Technology Co., Ltd.

K-Number K221711

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NQQ 2023-02-28

SpectraWAVE Imaging System

Applicant Spectrawave, Inc.

K-Number K221257

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OCX 2023-02-27

Saneso Lens Wash Bottle Assembly (SAN-LWB-A)

Applicant Saneso, Inc.

K-Number K222173

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EIH 2023-02-27

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)

Applicant Arum Dentistry Co., Ltd.

K-Number K223253

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QVI 2023-02-27

Ogmend® Implant Enhancement System

Applicant Woven Orthopedic Technologies

K-Number K223075

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HDX 2023-02-27

Milli Vaginal Dilator

Applicant Materna Medical

K-Number K220035

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PZJ 2023-02-27

Idylla MSI Test

Applicant Biocartis NV

K-Number K211181

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