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

MAX 2016-07-21

Tritanium® PL Cage

Applicant Stryker

K-Number K160955

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FRO 2016-07-21

Dakin's Skin and Wound Cleanser

Applicant Century Pharmaceuticals, Inc.

K-Number K150208

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EBF 2016-07-21

BioHPP - breCAM.BioHPP

Applicant Bredent GmbH & Co. KG

K-Number K152113

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EIH 2016-07-21

rainbow LS Block

Applicant Genoss Co., Ltd.

K-Number K160144

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NKG 2016-07-21

PathLoc-C Posterior Cervical Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K153439

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LON 2016-07-20

VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)

Applicant bioMerieux, Inc.

K-Number K161227

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FEB 2016-07-20

EVOTECH ECR

Applicant Advanced Sterilization Products (Asp)

K-Number K152189

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GEI 2016-07-20

XP1100 RF

Applicant BTL Industries, Inc.

K-Number K152731

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NUJ 2016-07-20

Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K160333

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DZE 2016-07-20

NR Line Implant System

Applicant Dentium Co., Ltd.

K-Number K153268

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ORC 2016-07-20

Operio

Applicant Toul Meditech AB

K-Number K153498

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OAN 2016-07-20

St. Louis Band

Applicant Orthomerica Products, Inc.

K-Number K161138

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