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

PZI 2016-11-15

StatStrip Xpress Glucose Hospital Meter System

Applicant Nova Biomedical Corporation

K-Number K161856

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DRF 2016-11-15

Achieve Advance Mapping Catheter

Applicant Medtronic, Inc.

K-Number K162892

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PHX 2016-11-15

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid

Applicant Tornier, Inc.

K-Number K161742

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MRG 2016-11-15

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set

Applicant Immunodiagnostic Systems , Ltd.

K-Number K161831

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IZL 2016-11-15

Optima XR240amx

Applicant Ge Medical Systems, LLC

K-Number K162990

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KTT 2016-11-15

Hoffman LRF System

Applicant Stryker GmbH

K-Number K161753

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IZL 2016-11-15

Digital Diagnostic Mobile X-ray System

Applicant Samsung Electronics Co., Ltd.

K-Number K162278

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IYE 2016-11-15

CushionCast Moldable Cushions

Applicant Izi Medical Products, LLC

K-Number K162265

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KDI 2016-11-15

Tablo Console

Applicant Outset Medical, Inc.

K-Number K160881

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FXX 2016-11-15

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

Applicant Protect U Guard, LLC

K-Number K153409

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OAS 2016-11-15

X-MIND trium

Applicant De Gotzen S.R.L.

K-Number K160166

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HQD 2016-11-15

SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co

Applicant Synergeyes, Inc.

K-Number K153714

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