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

NTB 2016-01-13

TheraVision Ultrasound Ablation System and ACOUSTx Applicators

Applicant Acoustic Medsystems, Inc.

K-Number K150019

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LLZ 2016-01-12

ImplantMax Software

Applicant Saturn Imaging, Inc.

K-Number K151152

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KCT 2016-01-12

Endoscope Sterilization Tray

Applicant Intuitive Surgical, Inc.

K-Number K151450

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ODA 2016-01-12

core nova Complete Operating Room Endoscopy

Applicant Richard Wolf Medical Instruments Corp.

K-Number K151282

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MQV 2016-01-12

Bio2 CLM BG Bioactive Scaffold

Applicant Bio2 Technologies, Inc.

K-Number K152589

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PSZ 2016-01-12

Sofia Influenza A+B FIA

Applicant Quidel Corporation

K-Number K153012

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NHA 2016-01-12

CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)

Applicant Altatec GmbH

K-Number K152509

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DQK 2016-01-12

MUSE Cardiology Information System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K152993

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OWB 2016-01-12

INFX-8000V, V6.20

Applicant Toshibamedical Systems Corporation

K-Number K152696

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BZG 2016-01-12

IQSense Flow Sensor Mouthpiece

Applicant Sdi Diagnostics, Inc.

K-Number K150515

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OWB 2016-01-12

Cios Connect

Applicant Siemens Medical Solutions USA, Inc.

K-Number K153147

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PGY 2016-01-12

3MP Color LCD Monitor, RadiForce RX350

Applicant Eizo Corporation

K-Number K153354

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