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

EOQ 2021-07-28

Broncho Videoscope System

Applicant Scivita Medical Technology Co., Ltd.

K-Number K210379

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PHX 2021-07-28

Catalyst R1 Reverse Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K211991

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FMF 2021-07-28

BD Flu+ Syringe

Applicant Becton, Dickinson and Company

K-Number K203359

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FLL 2021-07-28

Disposable Ear Thermometer Probe Cover

Applicant Huaian Zhongxin Packing Material Co., Ltd.

K-Number K203431

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EBI 2021-07-28

Pac-Dent Denture Base Resin

Applicant Pac-Dent, Inc.

K-Number K210189

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KWQ 2021-07-27

Fixxsure Anterior Lumbar Plate and Screw System

Applicant Oak Tree Engineering, LLC

K-Number K211932

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KPS 2021-07-27

PET VCAR

Applicant GE Medical Systems SCS

K-Number K211247

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PDU 2021-07-27

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

Applicant Ra Medical Systems,Inc

K-Number K210664

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LLZ 2021-07-27

aPROMISE

Applicant Exini Diagnostics AB

K-Number K211655

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DQY 2021-07-27

Rist 071 Radial Access Guide Catheter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K211990

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HRS 2021-07-27

Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System

Applicant Integra LifeSciences Corporation

K-Number K210016

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JAA 2021-07-27

Insight Agile DRF

Applicant Imaging Engineering, LLC

K-Number K210469

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