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

ELW 2018-06-13

PEAK NS033CF, PEAK NS017CF

Applicant Neosil Co., Ltd.

K-Number K180565

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NJM 2018-06-13

Signature Orthodontic System

Applicant Signature Orthodontics

K-Number K181271

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LYZ 2018-06-13

Vinyl Examination Glove (Clear, Non-Colored)

Applicant Zhicheng Trading Co., Ltd.

K-Number K180861

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OWP 2018-06-13

VERIFY Assert Self-Contained Biological Indicator

Applicant STERIS Corporation

K-Number K181442

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KPR 2018-06-13

Ysio Max

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K181279

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JAK 2018-06-13

HealthCCS

Applicant Zebra Medical Vision, Ltd.

K-Number K172983

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OUR 2018-06-13

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

Applicant Tenon Medical, Inc.

K-Number K180818

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ODP 2018-06-13

Atlas Spine Expandable Cervical Interbody System

Applicant Atlas Spine, Inc.

K-Number K180675

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LPL 2018-06-13

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)

Applicant Qualimed Srl

K-Number K181050

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ONF 2018-06-13

Harmony XL Multi-Application Platform

Applicant Alma Lasers, Inc.

K-Number K181298

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LSL 2018-06-13

Aptima Combo 2 Assay (Panther System)

Applicant Hologic, Inc.

K-Number K180681

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FRC 2018-06-13

CELERITY 20 HP Biological Indicator

Applicant STERIS Corporation

K-Number K181429

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