Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

OWN 2025-02-19

OPTOVISION Endoscopic Light Source Unit

Applicant Optosurgical, LLC

K-Number K243591

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KCT 2025-02-19

Microdent Sterilization Cassette

Applicant Implant Microdent System S.L.U.

K-Number K242023

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HRS 2025-02-19

A.L.P.S. Small Fragment Plating System

Applicant Biomet Orthopedics

K-Number K243761

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OWT 2025-02-19

Phasix ST Umbilical Hernia Patch

Applicant Davol, Inc., A Subsidiary of C.R. Bard, Inc.

K-Number K243241

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JAK 2025-02-19

Brainomix 360 e-Lung

Applicant Brainomix Limited

K-Number K242411

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GEX 2025-02-19

Single Use CO2 Laser Fiber (HAF005001)

Applicant Quanta System Spa

K-Number K243588

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MBI 2025-02-19

SuperBall-RC

Applicant Arcuro Medical , Ltd.

K-Number K244015

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NHA 2025-02-19

Straumann InLab Validated Workflow

Applicant Institut Straumann AG

K-Number K243478

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HRS 2025-02-19

EVOS Pelvic and Acetabular System

Applicant Smith & Nephew

K-Number K241666

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EIA 2025-02-19

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

Applicant Dci International, LLC

K-Number K250473

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DQA 2025-02-19

AViTA Pulse Oximeter (SP62B)

Applicant Avita Corporation

K-Number K242455

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QJP 2025-02-18

AXS Lift Intracranial Base Catheter

Applicant Stryker Neurovascular

K-Number K243593

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