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

LYZ 2016-07-14

Powder Free Grey Vinyl Examination Gloves

Applicant Zibo Flourish Trading Co., Ltd.

K-Number K161072

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JAI 2016-07-14

LEONI ORION System

Applicant Leoni Cia Cable System

K-Number K160518

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HHW 2016-07-14

Panpac Disposable Pessary Fitting Set

Applicant Panpac Medical Corporation

K-Number K153422

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MAX 2016-07-14

Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K160906

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KKY 2016-07-14

Biopor, AOC Porous Polyethylene, Cerepor

Applicant Ceremed , Inc.

K-Number K160988

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GAT 2016-07-14

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved

Applicant Ivy Sports Medicine, LLC

K-Number K153087

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LYC 2016-07-14

ShefaBone SCPC Resorbable Bone Graft

Applicant The Implantech Inc./Shefabone

K-Number K153230

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DJZ 2016-07-14

Soberlink Cellular Device and Sober Sky Web Portal

Applicant Soberlink Healthcare, LLC

K-Number K160613

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FED 2016-07-14

AmplifEYE

Applicant Medivators, Inc.

K-Number K160846

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NBY 2016-07-13

LOOK PTFE Suture

Applicant Surgical Specialties Corporation

K-Number K160744

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LZG 2016-07-13

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

Applicant Tandem Diabetes Care, Inc.

K-Number K160482

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HAW 2016-07-13

EXACTECH GPS

Applicant Blue Ortho

K-Number K152764

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