Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

DQK 2020-11-25

EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled

Applicant ABBOTT MEDICAL

K-Number K202066

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GEX 2020-11-25

Dermatological Carbon Dioxide Laser Systems

Applicant Zhuolu Jontelaser Manufacturing Technology Co., Ltd.

K-Number K202250

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JAK 2020-11-25

The Multimodality Advanced Vessel Analysis

Applicant Philips Medical Systems Nederland B.V.

K-Number K203216

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BTR 2020-11-25

Tenax Laser Resistant Endotracheal Tube

Applicant Bryan Medical, Inc.

K-Number K200761

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PHX 2020-11-25

GLOBAL UNITE™ Platform Shoulder System

Applicant Depuy Ireland UC

K-Number K202098

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GYB 2020-11-25

DR-HO'S Electro Therapy Conductive Gel

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K-Number K200402

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NKB 2020-11-25

CarboClear X Pedicle Screw System

Applicant CarboFix Orthopedics , Ltd.

K-Number K203317

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MBI 2020-11-25

Sterile bone screw (PEEK ACL screw)

Applicant Osteonic Co., Ltd.

K-Number K202883

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NHA 2020-11-25

PRE-MILLED Abutment

Applicant Mit Global Co., Ltd.

K-Number K202269

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CBP 2020-11-25

CPR Face Shield

Applicant Firstar Healthcare Company Limited (Guangzhou)

K-Number K192285

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KPO 2020-11-25

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis

Applicant Nipro Renal Solutions USA, Corp.

K-Number K193155

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IPF 2020-11-25

Physiq

Applicant El.En Electronic Engineering Spa

K-Number K202079

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