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

QIH 2020-10-30

WRDensity by Whiterabbit.ai

Applicant Whiterabbit.Ai, Inc.

K-Number K202013

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QKB 2020-10-30

AutoContour

Applicant Radformation, Inc.

K-Number K200323

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IYN 2020-10-30

T-Lite

Applicant Sonoscanner

K-Number K201988

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GEI 2020-10-30

Aesculap Caiman 5 Seal and Cut Technology System

Applicant Aesculap, Inc.

K-Number K202938

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DXH 2020-10-30

eCordum Cardiac Monitor (eCordum CM)

Applicant Ecordum, Inc.

K-Number K193296

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OMP 2020-10-30

PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack

Applicant Smith & Nephew Medical Limited

K-Number K202157

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ODP 2020-10-29

CONSTRUX Mini PEEK Spacer System

Applicant Orthofix, Inc.

K-Number K202949

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OQI 2020-10-29

Libertas E-XLPE Modular Liner

Applicant Maxx Orthopedics, Inc.

K-Number K192989

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FPA 2020-10-29

Female Luer Lock Cap

Applicant Medsafety Solutions, LLC

K-Number K200425

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EIH 2020-10-29

HCG Zirconia Ceramic Block

Applicant Hocheng Corporation

K-Number K193090

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QBP 2020-10-29

Curos Jet Disinfecting Cap

Applicant 3M Company

K-Number K200299

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KCT 2020-10-29

OsteoMed ExtremiFix Mini & Small System Tray

Applicant Osteomed, LLC

K-Number K202105

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