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

BTR 2019-07-30

Endotracheal Tube

Applicant Tianjin Medis Medical Device Co., Ltd.

K-Number K190274

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DRF 2019-07-30

Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

Applicant Medtronic

K-Number K183547

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NRY 2019-07-30

AXS Vecta Aspiration System

Applicant Stryker Neurovascular

K-Number K191768

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JFJ 2019-07-30

Atellica CH Amylase_2 (AMY_2)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K191454

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NUH 2019-07-30

Transcutaneous Electrical Nerve Stimulator

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K183288

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GEI 2019-07-30

Renuvion/J-Plasma Precise Handpiece

Applicant Apyx Medical Corporation(Formerly Bovie Medical Corporation)

K-Number K191484

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ODP 2019-07-30

Addivation Medical Cervical Interbody System

Applicant Addivation Medical, LLC

K-Number K190291

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JKA 2019-07-30

Blood Transfer Accessory (BTA)

Applicant Nsp Tech Pte, Ltd.

K-Number K181743

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DXN 2019-07-29

Non-invasive blood pressure measurement systems

Applicant Joytech Healthcare Co. , Ltd.

K-Number K190886

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OAP 2019-07-29

Hair Boom 69

Applicant Wontech

K-Number K191154

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HWC 2019-07-29

Bone Screw Line Addition

Applicant Vilex IN Tennessee, Inc.

K-Number K191289

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IYE 2019-07-29

BiomarC Fiducial Marker

Applicant Carbon Medical Technologies

K-Number K191797

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