Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

KGO 2017-01-23

Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K161823

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MQH 2017-01-23

EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip

Applicant Research Instruments Limited

K-Number K161275

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HRN 2017-01-23

D.O.R.C. Disposable Cryo Probe

Applicant Dutch Ophthalmic Research Center International BV

K-Number K160591

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HIS 2017-01-23

Lifestyles Zero Lubricated Latex Male Condom

Applicant Ansell Healthcare Products, LLC

K-Number K163107

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NBW 2017-01-19

UniStrip1 Generic Blood Glucose Test Strips

Applicant Ok Biotech Co., Ltd.

K-Number K162430

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JWH 2017-01-19

Anatomic Total Knee System

Applicant Amplitude

K-Number K161414

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DZE 2017-01-19

GMI Frontier Dental Implant System

Applicant Ilerimplant S.L

K-Number K161593

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OMP 2017-01-19

Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set

Applicant Cardinalhealth

K-Number K161418

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OLV 2017-01-19

Polysmith Sleep System, Model NTI7593

Applicant Neurotronics, Inc.

K-Number K161650

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EGS 2017-01-19

Titan 3 Low Speed Angle Attachments

Applicant Dentalez, Inc.

K-Number K162397

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PQX 2017-01-19

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

Applicant Certa Dose, Inc.

K-Number K160589

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JOW 2017-01-19

Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves

Applicant Covidien

K-Number K163620

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