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

NUC 2016-08-31

Trojan Chain Reaction Personal Lubricant

Applicant Church & Dwight Co., Inc.

K-Number K161544

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HCG 2016-08-31

MicroPlex Coil System (MCS) - HyperSoft 3D

Applicant MicroVention, Inc.

K-Number K161452

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FEQ 2016-08-31

Erbe’s CO2 Tubing/Cap Sets

Applicant Erbe USA, Inc.

K-Number K162152

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KIF 2016-08-31

MTA Repair HP

Applicant Angelus Industria DE Productos Odontologicos

K-Number K151047

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OCW 2016-08-30

Miret Grasper, Alligator, Miret Grasper, Maryland

Applicant Miret Surgical, Inc.

K-Number K160149

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JAK 2016-08-30

OnSight 3D Extremity System

Applicant Carestream Health, Inc.

K-Number K160723

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MNH 2016-08-30

ANAX™ 5.5 Spinal System

Applicant U&I Corporation

K-Number K162189

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FRN 2016-08-30

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)

Applicant Zyno Medical, LLC

K-Number K153193

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DKZ 2016-08-30

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

Applicant Hangzhou Clongene Biotech Co., Ltd.

K-Number K161251

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OUY 2016-08-29

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

Applicant Cepheid

K-Number K161619

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FLL 2016-08-29

Digital Thermometer

Applicant Biocare Asia Corporation , Ltd.

K-Number K161211

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FOZ 2016-08-29

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K161777

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