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

NHA 2018-10-31

Universal Base Abutment

Applicant Nobel Biocare AB

K-Number K180899

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JWH 2018-10-31

Balanced Knee Revision System Trabecular Tibial Cone Augments

Applicant Ortho Development Corporation

K-Number K182085

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KPR 2018-10-31

Halifax Imaging Kit

Applicant Halifax Biomedical, Inc.

K-Number K182880

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FCG 2018-10-31

Single Use Aspiration Needle NA-U201H

Applicant Olympus Medical Systems Corp.

K-Number K181994

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NUJ 2018-10-31

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider

Applicant Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K-Number K182588

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DIC 2018-10-31

Immunalysis Ethyl Alcohol Enzyme Assay

Applicant Immunalysis Corporation

K-Number K181553

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NEU 2018-10-31

Tumark for Eviva, Tumark for Brevera

Applicant Somatex Medical Technologies GmbH

K-Number K182082

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HIG 2018-10-31

Endomat Select

Applicant Karl Storz SE & CO. KG

K-Number K180735

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IYN 2018-10-31

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1

Applicant Canon Medical Systems Corporation

K-Number K182679

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GEX 2018-10-31

XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro

Applicant Fotona D.O.O.

K-Number K182088

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LQR 2018-10-30

Wilson-Cook Mini Basket

Applicant Wilson-Cook Medical, Inc.

K-Number K182381

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DYW 2018-10-30

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

Applicant Tomy, Inc.

K-Number K180718

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