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

LHN 2017-12-26

Real Time Image Gating System for Proton Beam Therapy Systems

Applicant Hitachi, Ltd. Healthcare

K-Number K171049

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GWQ 2017-12-26

NEURONAUTE

Applicant Bioserenity

K-Number K170138

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MQV 2017-12-26

SCS 17-01

Applicant Anika Therapeutics, Inc.

K-Number K173008

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GJS 2017-12-25

CoaguChek Vantus System

Applicant Roche Diagnostics

K-Number K170960

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OYX 2017-12-22

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

Applicant Molecularmd Corporation

K-Number K173492

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NXO 2017-12-22

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer

Applicant Inova Diagnostics, Inc.

K-Number K170993

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QAG 2017-12-22

remOVE System

Applicant Ovesco Endoscopy AG

K-Number DEN160014

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IWB 2017-12-22

GammaPod - Model A

Applicant Xcision Medical Systems, LLC

K-Number K172706

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KWI 2017-12-22

Align Radial Head System

Applicant Skeletal Dynamics, LLC

K-Number K172688

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JXL 2017-12-22

SurgeoBite

Applicant Surgovations, LLC

K-Number K172978

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BSO 2017-12-22

B. Braun Tear-Away Introducer Needle

Applicant B.Braun Medical, Inc.

K-Number K171584

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JHI 2017-12-22

TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)

Applicant True Diagnostics, Inc.

K-Number K172257

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