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

NGX 2017-02-16

AM-100

Applicant BTL Industries, Inc.

K-Number K163165

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GEI 2017-02-16

Valleylab FT10 Electrosurgical Platform

Applicant Covidien, LLC

K-Number K170170

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DZE 2017-02-15

IBS Implant System II

Applicant Innobiosurg Co., Ltd.

K-Number K162099

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JIT 2017-02-15

Abbott ARCHITECT Free T3

Applicant Abbott Laboratories

K-Number K170160

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DPS 2017-02-15

PC ECG

Applicant Edan Instruments, Inc.

K-Number K160876

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PNR 2017-02-15

Medela Low Dose Enteral Syringe

Applicant Medela, Inc.

K-Number K161811

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MXD 2017-02-14

Reveal LINQ Insertable Cardiac Monitor

Applicant Medtronic, Inc.

K-Number K163460

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OZN 2017-02-14

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

Applicant Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC

K-Number K163085

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NKB 2017-02-14

Erisma® LP Spinal Fixation System

Applicant Clariance, Sas

K-Number K170163

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IPF 2017-02-14

FA100 SCCD (Sequential Continuous Contraction Device)

Applicant Flowaid Medical Technologies, Corp

K-Number K162987

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GEH 2017-02-14

ClariFix Device

Applicant Arrinex, Inc.

K-Number K162608

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PRD 2017-02-14

FilmArray NGDS Warrior Panel

Applicant Biofire Defense, LLC

K-Number DEN160048

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