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

NKB 2020-10-21

Trivergent Spinal Fixation System

Applicant Benvenue Medical, Inc.

K-Number K201427

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LPH 2020-10-21

ACTIS Duofix Hip Prosthesis

Applicant DePuy Orthopaedics, Inc.

K-Number K202472

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NEU 2020-10-21

C4 Fiducial Marker

Applicant C4 Imaging, LLC

K-Number K192771

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PNG 2020-10-21

PleurX Peritoneal Catheter System

Applicant Care Fusion

K-Number K201155

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KCT 2020-10-21

S.I.N. Instrument Kits

Applicant S.I.N. - Sistema DE Implante Nacional S.A.

K-Number K201688

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KGN 2020-10-21

InnovaMatrix

Applicant Triad Life Sciences, Inc.

K-Number K193552

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GMQ 2020-10-21

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

Applicant Arlington Scientific, Inc. (Asi)

K-Number K201438

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LNH 2020-10-21

OASIS MRI System

Applicant Hitachi Healthcare Americas

K-Number K202030

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MXK 2020-10-21

Pentacam AXL Wave

Applicant Oculus Optikgerate GmbH

K-Number K201724

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HQF 2020-10-21

Iridex 810 Laser

Applicant Iridex Corporation

K-Number K202760

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LPL 2020-10-21

Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

Applicant Plexus Optix, Inc.

K-Number K201268

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GXD 2020-10-21

IonicRF Generator

Applicant ABBOTT MEDICAL

K-Number K201610

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