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

FOZ 2016-11-15

AccuCath Intravascular Catheter

Applicant C.R. Bard, Inc.

K-Number K162894

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JSO 2016-11-15

HardyCHROM ESBL

Applicant Hardy Diagnostics

K-Number K160512

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HWC 2016-11-15

AmorChem Titanium Porous Fixation Device

Applicant Amorchem Holdings, Inc.

K-Number K160791

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GEI 2016-11-14

Ligasure Blunt Tip, Sealer/Divider, Nano-coated

Applicant Covidien

K-Number K162941

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PNG 2016-11-14

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

Applicant Rocket Medical Plc

K-Number K162457

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GDW 2016-11-14

FasTouch Fixation System

Applicant Via Surgical , Ltd.

K-Number K162252

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OUR 2016-11-14

PathLoc-SI Joint Fusion System

Applicant L&K BIOMED Co., Ltd.

K-Number K153656

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IMJ 2016-11-14

ThermoPro

Applicant Zimmer Medizinsysteme GmbH

K-Number K161862

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MWI 2016-11-14

Vital Sync Informatics Manager & Virtual Patient Monitoring Platform

Applicant Covidien

K-Number K160718

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NBW 2016-11-10

FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems

Applicant Taidoc Technology Corporation

K-Number K161738

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DXT 2016-11-10

Sunmed Control Syringes

Applicant Sunny Medical Device (Shenzhen) Co., Ltd.

K-Number K160190

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FRO 2016-11-10

Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL

Applicant B.Braun Medical, Inc.

K-Number K161623

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