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

DQK 2018-07-25

RHYTHMIA HDx Mapping System (with software Version 2.0)

Applicant Boston Scientific Corporation

K-Number K173837

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CAF 2018-07-25

Smartinhaler

Applicant Adherium (Nz), Ltd.

K-Number K180407

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NKB 2018-07-25

Republic Spine Dark Star Spinal System

Applicant Republic Spine, LLC

K-Number K181495

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MAX 2018-07-25

Lumbar Interbody Fusion System (OLLIF)

Applicant Advanced Research Medical, LLC

K-Number K173947

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OWB 2018-07-25

Alphenix, INFX-8000V/B, V8.0

Applicant Canon Medical Systems Corporation

K-Number K181670

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HIH 2018-07-25

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole

Applicant Corinth Medtech, Inc.

K-Number K180752

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NKB 2018-07-25

TREND II Spinal Fixation System- STEP Series

Applicant Paonan Biotech Co., Ltd.

K-Number K180226

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MAX 2018-07-25

ATEC ALIF Spacer System

Applicant Alphatec Spine, Inc.

K-Number K181453

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PHX 2018-07-25

Exactech Equinoxe Small Reverse Shoulder System

Applicant Exactech, Inc.

K-Number K180632

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MAI 2018-07-25

FIXIT / ComposiTCP Threaded Anchor System

Applicant S.B.M. Sas Sciences For Bio Materials

K-Number K180960

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MHX 2018-07-24

MX40 Release C.01

Applicant Philips Medical Systems

K-Number K180017

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OCC 2018-07-24

Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

Applicant Cepheid

K-Number K180218

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