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

LBH 2020-01-23

FiteBac Cavity Cleanser

Applicant Largent Health, LLC

K-Number K190271

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LLZ 2020-01-23

Elements Viewer

Applicant Brainlab AG

K-Number K191014

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EMA 2020-01-23

Surefil one Self-adhesive Composite Hybrid

Applicant Dentsply Sirona

K-Number K192530

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FRC 2020-01-23

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

Applicant Advanced Sterilization Products (Asp)

K-Number K192025

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FQH 2020-01-23

Bactisure Wound Lavage

Applicant Next Science, LLC

K-Number K192349

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GDW 2020-01-23

EEA Circular Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K192330

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JTN 2020-01-23

HardyDisk AST Cefiderocol 30ug (FDC30)

Applicant Hardy Diagnostics

K-Number K193504

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DZE 2020-01-22

Internal Hex Implant System

Applicant Ebi, Inc.

K-Number K190837

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KPO 2020-01-22

Isopure Dry Acid Dissolution System

Applicant Isopure, Corp.

K-Number K191093

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MBI 2020-01-22

Y-Knot OneStep Anchor

Applicant Conmed Corporation

K-Number K193606

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OLT 2020-01-22

E-EEGX, N-EEGX

Applicant GE Healthcare Finland Oy

K-Number K191322

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OVD 2020-01-22

SCARLET AL-T

Applicant Spineart

K-Number K192993

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