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

PBX 2016-10-03

Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care

Applicant Indiba USA, Inc.

K-Number K161458

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JAQ 2016-10-02

Esophagus Bougie Set

Applicant Varian Medical Systems, Inc.

K-Number K161576

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MXJ 2016-10-01

SeraQuest Herpes Type 1 Specific IgG

Applicant Quest International, Inc.

K-Number K162276

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GJS 2016-09-30

Xprecia Stride Coagulation System, Xprecia System PT Controls

Applicant Siemens Healthcare Diagnostics

K-Number K151964

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ODP 2016-09-30

InterForm Cervical Interbody Cage System

Applicant Next Orthosurgical

K-Number K161608

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MOF 2016-09-30

Traxcess .007 Mini Guidewire

Applicant MicroVention, Inc.

K-Number K161803

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NLH 2016-09-30

Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters

Applicant Innovative Health, LLC

K-Number K161464

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BSO 2016-09-30

ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit

Applicant Halyard Health

K-Number K161232

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PGY 2016-09-30

8MP Color LCD Monitor (C81W+)

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K-Number K162527

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EMA 2016-09-30

TempoCem Clear

Applicant Dmg USA, Inc.

K-Number K160443

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OAP 2016-09-30

LaserCap300, LaserCap224, LaserCap120, LaserCap80

Applicant Transdermal Cap, Inc.

K-Number K161875

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IYN 2016-09-30

Xario 100 Diagnostic Ultrasound System, V5.0

Applicant Toshibamedical Systems Corporation

K-Number K162187

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