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

MAX 2019-07-25

Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage

Applicant Stryker Spine

K-Number K183249

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EBW 2019-07-25

Maxima Electric System

Applicant Handpiece Headquarters - Hpr, Inc.

K-Number K180845

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FRO 2019-07-25

Silicone PHMB Foam Wound Dressing

Applicant Advanced Medical Solutions, Ltd.

K-Number K190819

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HSX 2019-07-25

JOURNEY II Unicompartmental Knee System

Applicant Smith & Nephew, Inc.

K-Number K191211

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DYB 2019-07-25

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model

Applicant Access Scientific, LLC

K-Number K183066

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OCC 2019-07-24

Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System

Applicant Roche Molecular Systems, Inc.

K-Number K191729

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OBO 2019-07-24

Canon OCT-A1

Applicant Canon, Inc.

K-Number K182942

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MRC 2019-07-24

MaxiTears Contacts PF

Applicant Omnivision AG

K-Number K182984

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NKB 2019-07-24

4CIS® Chiron Spinal Fixation System

Applicant Solco Biomedical Co., Ltd.

K-Number K190471

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GEI 2019-07-24

TempSure

Applicant Cynosure, Inc.

K-Number K190678

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OLO 2019-07-24

ExcelsiusGPS Spine 1.1 Interbody Module

Applicant Globus Medical, Inc.

K-Number K191100

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OCL 2019-07-24

Coolrail Linear Pen

Applicant AtriCure, Inc.

K-Number K190587

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