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

HEX 2016-12-19

EVA (Enhanced Visual Assessment) System

Applicant Mobileodt , Ltd.

K-Number K161871

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LYZ 2016-12-19

Vinyl Exam Gloves, Powder Free, Clear

Applicant Zibo Hongchin Plastic and Rubber Co., Ltd.

K-Number K161390

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JWH 2016-12-19

PS2 Knee System

Applicant Consensus Orthopedics, Inc.

K-Number K160515

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JWH 2016-12-19

Destiknee Total Knee System

Applicant Meril Healthcare Private Limited

K-Number K160771

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JWY 2016-12-19

Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml

Applicant Liofilchem s.r.l.

K-Number K162854

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GAT 2016-12-19

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture

Applicant Biomet Manafacturing Corp.

K-Number K160854

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FPA 2016-12-19

Paclitaxel Sets

Applicant Baxter Healthcare Corporation

K-Number K160007

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PDJ 2016-12-19

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

Applicant Roche Diagnostics Operations (Rdo)

K-Number K160571

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FMF 2016-12-19

BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe

Applicant Becton, Dickinson and Company

K-Number K162081

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PNU 2016-12-19

Hem-Avert Perianal Stabilizer

Applicant Stetrix, Inc.

K-Number DEN160005

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PQO 2016-12-19

Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5

Applicant Roche Diagnostics

K-Number DEN150057

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LPL 2016-12-19

Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

Applicant Pegavision Corporation

K-Number K161739

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