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

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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KPS 2016-01-12

Biograph Horizon PET/CT

Applicant Siemens Medical Solutions USA, Inc.

K-Number K152880

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FAD 2016-01-11

Universa Soft Ureteral Stents and Stent Sets

Applicant Cook Incorporated

K-Number K151051

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JPA 2016-01-11

Sysmex Automated Blood Coagulation Analyzer CS-5100

Applicant Siemens Healthcare Diagnostic Products GmbH

K-Number K150678

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