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

JAK 2023-11-16

CT Lung Ventilation Analysis Software (CT:V)

Applicant 4Dmedical Limited

K-Number K232392

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LPL 2023-11-16

Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens

Applicant Innova Vision, Inc.

K-Number K232139

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LPL 2023-11-16

DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric

Applicant Alcon Laboratories, Inc.

K-Number K232921

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DTZ 2023-11-16

D100 KIDS; D101 KIDS

Applicant Sorin Group Italia S.R.L.

K-Number K231652

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MQB 2023-11-16

EXPD 4343D; EXPD 3643D

Applicant DRTECH Corporation

K-Number K232753

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NIE 2023-11-16

Trio-CT® Triple Lumen Catheter w/ Curved Extensions

Applicant Medical Components, Inc. (dba MedComp)

K-Number K232945

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MNU 2023-11-16

OSSIOfiber® Compression Staple

Applicant OSSIO , Ltd.

K-Number K233302

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NKB 2023-11-16

MASADA Modular Spinal Fixation System

Applicant Astura Medical

K-Number K231694

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OLO 2023-11-16

Vital™ Navigation System

Applicant Zimvie Spine (Zimmer Biomet Spine, Inc.)

K-Number K233443

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PHX 2023-11-16

LINK Embrace Shoulder System - Reverse Configuration

Applicant Waldemar Link GmbH & Co. KG

K-Number K231445

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NEY 2023-11-16

NEUWAVE™ Microwave Ablation System and Accessories

Applicant Neuwave Medical, Inc.

K-Number K231738

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MKZ 2023-11-16

Aptima® Chlamydia trachomatis Assay

Applicant Hologic, Inc.

K-Number K230451

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