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

LPL 2023-12-29

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K233856

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JPA 2023-12-29

ACL TOP 970 CL

Applicant Instrumentation Laboratory

K-Number K233790

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DZE 2023-12-29

UniFit Dental Implant System

Applicant Adin Dental Implant Systems , Ltd.

K-Number K223714

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HIR 2023-12-29

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

Applicant Pelvital USA, Inc.

K-Number K233362

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IYO 2023-12-29

Bladder Scanner

Applicant Avantsonic Technology Co., Ltd.

K-Number K230986

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DZE 2023-12-29

URIS Smart Path Implant System & Prosthetic

Applicant Truabutment, Inc.

K-Number K230438

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PZO 2023-12-28

Ankyras

Applicant Mentice Spain S.L.

K-Number K230006

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LZA 2023-12-28

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K233405

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OAS 2023-12-28

Planmeca Viso

Applicant Planmeca Oy

K-Number K230985

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EHD 2023-12-28

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)

Applicant De Götzen S.R.L.

K-Number K231055

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MBI 2023-12-28

SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant

Applicant Healthium Medtech Limited

K-Number K230891

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GZI 2023-12-28

EvoWalk 1.0 System

Applicant Evolution Devices, Inc.

K-Number K230997

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