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

LZO 2024-08-27

Z1 Cemented Hip System

Applicant Orchard Medical Development, LLC

K-Number K241241

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QIH 2024-08-27

Overjet Charting Assist

Applicant Overjet, Inc.

K-Number K241684

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FBK 2024-08-27

injeTAK Adjustable Tip Needle (DIS199; DIS201)

Applicant Laborie Medical Technologies, Corp.

K-Number K241523

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MQL 2024-08-27

Vitrification Solution Set and Warming Solution Set

Applicant Ecmpc, LLC

K-Number K233846

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NBW 2024-08-27

CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care U.S., Inc.

K-Number K241787

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DYH 2024-08-27

BracePaste Fluoride Sealant

Applicant American Orthodontics Corp.

K-Number K242537

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OLO 2024-08-27

Q Guidance System; Mako Spine System;

Applicant Stryker Leibinger GmbH & Co KG

K-Number K241517

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KJJ 2024-08-27

Sealer Solvent

Applicant Inter-Med, Inc.

K-Number K241354

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NHA 2024-08-26

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K240982

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IZQ 2024-08-26

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Applicant Ulrich GmbH & Co. KG

K-Number K241850

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PKL 2024-08-26

BARS Set (100.60)

Applicant Ovesco Endoscopy AG

K-Number K241858

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LNH 2024-08-26

MyoStrain (6.0)

Applicant Myocardial Solutions, Inc.

K-Number K241607

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