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

OAT 2021-10-15

Ortho MI System

Applicant Osteonic Co., Ltd.

K-Number K211992

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OBJ 2021-10-15

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter

Applicant Siemens Medical Solutions USA, Inc.

K-Number K212959

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OVD 2021-10-15

AxTiHA Stand-Alone ALIF System

Applicant Innovasis, Inc.

K-Number K212967

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NBW 2021-10-15

MultiSure GK Link Blood Glucose and Ketone Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K201880

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DXN 2021-10-15

Arm Blood Pressure Monitor

Applicant Alicn Medical Shenzhen, Inc.

K-Number K210563

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PON 2021-10-15

Aqueduct 200 Cervical Dilation Balloon Catheter

Applicant Gtimd, LLC

K-Number K202433

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PTI 2021-10-14

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit

Applicant Intera Oncology, Inc.

K-Number K211121

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DYB 2021-10-14

SCORPION Portal Vein Access Set

Applicant Argon Medical Devices

K-Number K213002

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MEG 2021-10-14

Sterile Syringe With Safety Needle

Applicant Jiangxi Hongda Medical Equipment Group , Ltd.

K-Number K211753

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FXX 2021-10-14

Medical Protective Masks

Applicant Qinhuangdao Taizhi Medical Technology Co., Ltd.

K-Number K212205

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OTJ 2021-10-14

AFS Medical Sterile Single-Use Access Port System

Applicant Afs Medical Co. , Ltd.

K-Number K202688

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EBF 2021-10-14

Vittra APS Unique

Applicant Dentscare Ltda

K-Number K210231

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