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

LZA 2022-09-09

Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)

Applicant Careglove Global Sdn. Bhd.

K-Number K220859

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FXX 2022-09-09

PointCore Surgical Mask

Applicant Pointcore, Inc.

K-Number K220944

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HQC 2022-09-09

MICOR Lens Fragmentation System

Applicant Carl Zeiss Meditec Cataract Technology, Inc.

K-Number K214028

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EBF 2022-09-09

AMBARINO High-Class

Applicant Creamed GmbH & Co. Produktions- Und Handels KG

K-Number K222723

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GXY 2022-09-09

Dexus Prosthetics System (Model: MSL1, MSR1)

Applicant Zhejiang Qiangnao Technology Co.,Ltd

K-Number K220002

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GAT 2022-09-09

Arthrex SutureTape

Applicant Arthrex, Inc.

K-Number K221354

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MLR 2022-09-09

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System

Applicant Steris

K-Number K222093

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FRG 2022-09-09

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

Applicant Steris

K-Number K222440

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HSB 2022-09-09

AUTOBAHN(R) EVO Femoral Nails

Applicant Globus Medical, Inc.

K-Number K220659

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GEI 2022-09-09

Ellusa Reusable Bipolar Cable

Applicant Ellusa, LLC

K-Number K222429

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ELW 2022-09-09

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)

Applicant Prevest Denpro Limited

K-Number K213244

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NKG 2022-09-09

NuVasive Reline Cervical System

Applicant Nu Vasive, Incorporated

K-Number K221388

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