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

OHT 2018-05-11

Light based hair removal device

Applicant Shenzhen Gsd Tech Co., Ltd.

K-Number K180383

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LZA 2018-05-10

Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange

Applicant Gmp Medicare Sdn Bhd (F25)

K-Number K172867

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PGY 2018-05-10

RadiForce MX194

Applicant Eizo Corporation

K-Number K180961

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LXJ 2018-05-10

UINCARE HOME

Applicant Uincare Corp.

K-Number K172882

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JOW 2018-05-10

ANGIO-PRESS LITE DVT Compression Device

Applicant Pegasus Medical Supply, Inc.

K-Number K173012

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MAI 2018-05-10

HEALIX ADVANCE KNOTLESS BR Anchor

Applicant Medos International SARL

K-Number K180101

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GAM 2018-05-10

Rondek PGA Suture (Beige or Violet)

Applicant Rk Manufacturing Corporation

K-Number K180625

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MUD 2018-05-10

FORE-SIGHT ELITE Module Tissue Oximeter

Applicant Cas Medical Systems, Inc.

K-Number K180003

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DZE 2018-05-10

OKTAGON Implant System

Applicant Hager& Meisinger GmbH

K-Number K180360

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FMF 2018-05-10

Graftgun Universal Graft Delivery System

Applicant SurGenTec, LLC

K-Number K180937

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HSB 2018-05-10

OrthoPediatrics PediNail Intramedullary Platform

Applicant Orthopediatrics, Inc.

K-Number K172583

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KCT 2018-05-10

OsteoMed QuickFix Hybrid MMF Sterilization Tray

Applicant Osteomed, LLC

K-Number K173391

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