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

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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LNH 2018-06-12

SyMRI

Applicant Syntheticmr AB

K-Number K181093

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MMI 2018-06-12

Access hs Tnl

Applicant Beckman Coulter, Inc.

K-Number K172783

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FRN 2018-06-12

Perfusor® Space Syringe Infusion Pump System

Applicant B.Braun Medical, Inc.

K-Number K172831

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LZA 2018-06-12

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

Applicant Riverstone Resources Sdn Bhd

K-Number K180452

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BSP 2018-06-12

Portex NRFit Epidural Needles

Applicant Smiths Medical Asd, Inc.

K-Number K172823

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LRK 2018-06-12

ZQuiet

Applicant Sleeping Well, LLC

K-Number K180124

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OQI 2018-06-12

E-XPE Acetabular Components and U-Motion II Acetabular Cup

Applicant United Orthopedic Corporation

K-Number K172833

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