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

MQK 2018-02-09

iVitri Straw

Applicant Reprobitech Corp.

K-Number K172751

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MLR 2018-02-09

V-PRO maX 2 Low Temperature Sterilization System

Applicant STERIS Corporation

K-Number K172754

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LIT 2018-02-09

Jade PTA Balloon Dilatation Catheter

Applicant Orbusneich Medical Trading, Inc.

K-Number K173894

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DZE 2018-02-09

BR Type Implant System

Applicant Biotem Co., Ltd.

K-Number K171179

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FLL 2018-02-09

AT-6XX Series Infrared Thermometer

Applicant Xiamen Acurio Instruments Co., Ltd.

K-Number K171455

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FRG 2018-02-09

Vis-U-All Low Temperature Sterilization Pouch/Tubing

Applicant STERIS Corporation

K-Number K172749

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JOJ 2018-02-09

VERIFY VH2O2 Indicator Tape

Applicant STERIS Corporation

K-Number K172753

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FRC 2018-02-09

CELERITY 20 HP Biological Indicator

Applicant STERIS Corporation

K-Number K172752

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FRC 2018-02-09

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

Applicant Steris Corporations

K-Number K172748

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KPR 2018-02-09

Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System

Applicant Summit Industries, LLC

K-Number K173823

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KCT 2018-02-09

PRO-LITE Sterilization Trays

Applicant STERIS Corporation

K-Number K172755

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FRC 2018-02-09

3M Attest Rapid Readout Biological Indicator

Applicant 3M Company

K-Number K173435

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