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

MQV 2018-01-19

BioSphere MIS Putty (BioSphere MIS)

Applicant Synergy Biomedical, LLC

K-Number K173301

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KRD 2018-01-19

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume

Applicant Vascular Solutions, Inc.

K-Number K173891

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NXC 2018-01-19

Angel Align System

Applicant Smile Development Corp

K-Number K171674

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MAX 2018-01-19

FORZA® XP Expandable Spacer System

Applicant Orthofix, Inc.

K-Number K172696

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JWH 2018-01-19

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

Applicant Stelkast, Inc.

K-Number K173875

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EOQ 2018-01-19

PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope

Applicant Pentax of America, Inc.

K-Number K173554

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HTY 2018-01-19

DIP Arthrodesis System

Applicant In2bones Sas

K-Number K173616

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FDF 2018-01-19

Focus Cap

Applicant Gce Medical Corporation

K-Number K171673

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MAX 2018-01-19

Reliance Lumbar IBF System

Applicant Reliance Medical Systems, LLC

K-Number K173283

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EOQ 2018-01-19

FUJIFILM Bronchoscope Model EB-530P

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K171291

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MNS 2018-01-19

ReddyPort NIV Access Elbow

Applicant Smd Manufacturing, LLC

K-Number K171827

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JAK 2018-01-19

OnSight 3D Extremity System

Applicant Carestream Health, Inc.

K-Number K173478

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