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

LPL 2019-09-06

Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens

Applicant Lentechs, LLC

K-Number K191121

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LZA 2019-09-06

Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs

Applicant Ever Global (Vietnam) Enterprise Corporation

K-Number K190403

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FMF 2019-09-06

Sure-Fine Insulin Syringes

Applicant Shina Med Corporation

K-Number K191531

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JOJ 2019-09-05

Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label

Applicant STERIS Corporation

K-Number K192020

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FMI 2019-09-05

Dual-Safety Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K191853

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GEX 2019-09-05

Holinwon 30

Applicant Wontech Co., Ltd.

K-Number K183563

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FLL 2019-09-05

Advocate Non-Contact Infrared Thermometer

Applicant Broadmaster Biotech, Corp.

K-Number K191004

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MQL 2019-09-05

GM501 Wash

Applicant Hamilton Thorne, Inc.

K-Number K190383

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EBG 2019-09-05

SmarTemp X1

Applicant Parkell, Inc.

K-Number K190930

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JWH 2019-09-05

Persona Revision Knee System

Applicant Zimmer, Inc.

K-Number K191625

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NXC 2019-09-05

3M Clarity Aligners

Applicant 3M Company

K-Number K192119

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MED 2019-09-05

SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900

Applicant STERIS Corporation

K-Number K191343

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