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

OVD 2019-05-23

Rampart One Lumbar Interbody Fusion System

Applicant Spineology, Inc.

K-Number K191091

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GEI 2019-05-22

Erbe ESU Model VIO 3 with Accessories

Applicant Erbe Elektromedizin GmbH

K-Number K190823

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IYO 2019-05-22

Bladder Scanner (Models: M2, M2-W, M1, M1-W)

Applicant Suzhou Lischka Medtech Co., Ltd.

K-Number K190769

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DXQ 2019-05-22

RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope

Applicant Wenzhou Renhua Instruments Co., Ltd.

K-Number K190902

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IYN 2019-05-22

HERA I10 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K190444

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GEI 2019-05-22

Soniquence RF Generator and Soniquence Electrodes

Applicant Soniquence, LLC

K-Number K183611

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EOB 2019-05-22

Ambu aScope 4 RhinoLaryngo Slim

Applicant Ambu A/S

K-Number K191080

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EIH 2019-05-22

Dental Ceramic

Applicant Baot Biological Technology Co., Ltd.

K-Number K182350

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QEP 2019-05-22

cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit

Applicant Roche Molecular Systems, Inc.

K-Number K190433

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OLO 2019-05-22

Stealth-Midas MR8 System

Applicant Medtronic Powered Surgical Solutions

K-Number K183644

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NKG 2019-05-22

Connector System

Applicant Orthofix, Inc.

K-Number K190751

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IYE 2019-05-22

LIAC S

Applicant Sit Sordina Iort Technologies Spa

K-Number K182374

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