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

MAX 2023-07-25

Exceed™ Biplanar Expandable Interbody System

Applicant Spine Wave, Inc.

K-Number K231275

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OWQ 2023-07-25

Reprocessed ViewFlex Xtra ICE Catheter (D087031)

Applicant Stryker Sustainability Solutions

K-Number K231621

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IYN 2023-07-25

Sonio Detect

Applicant Sonio

K-Number K230365

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PBQ 2023-07-25

Apyx

Applicant Escala Medical

K-Number K230730

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JGS 2023-07-25

A-LYTE® Integrated Multisensor (IMT Na K Cl)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K222438

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LBH 2023-07-24

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)

Applicant Kettenbach GmbH & Co. KG

K-Number K230333

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LZA 2023-07-24

Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl

Applicant Central Medicare Sdn Bhd

K-Number K223752

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EBF 2023-07-24

EsCom250

Applicant Spident Co., Ltd.

K-Number K231523

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QJU 2023-07-24

UltraSight AI Guidance

Applicant Ultrasight, Inc.

K-Number K223347

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LLZ 2023-07-24

Argus Cognitive ReVISION Software

Applicant Argus Cognitive, Inc.

K-Number K223322

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BSZ 2023-07-23

Atlan

Applicant Drägerwerk AG Co. Kgaa

K-Number K230931

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OLI 2023-07-21

Erchonia Violet ZERONA® Z6 OTC

Applicant Erchonia Corporation

K-Number K231474

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