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

OWB 2020-05-01

Azurion R2.1

Applicant Philips Medical Systems Nederland B.V.

K-Number K200917

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DSH 2020-05-01

Carnation Ambulatory Monitor

Applicant Bardy Diagnostics, Inc.

K-Number K200870

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GCA 2020-05-01

Stone Retrieval Balloon

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K200173

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LJS 2020-04-30

Biowy PICC Catheter S Kit

Applicant Biowy Corporation

K-Number K192246

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LLZ 2020-04-30

ArthrexVIP Web Portal

Applicant Arthrex, Inc.

K-Number K193523

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ONG 2020-04-30

Medical Non-Ablative Fractional Laser Systems

Applicant Wingderm Electro-Optics , Ltd.

K-Number K192350

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FYA 2020-04-30

50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown

Applicant Xuchang Zhengde Environstar Medical Products Co., Ltd.

K-Number K192290

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MAX 2020-04-30

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices

Applicant Spineex, Inc.

K-Number K200816

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GCJ 2020-04-30

ClickClean

Applicant Medeon Biodesign, Inc.

K-Number K200902

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NKB 2020-04-30

CarboClear® II Pedicle Screw System

Applicant CarboFix Orthopedics , Ltd.

K-Number K200519

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DXG 2020-04-30

PulsioFlex Monitoring System with ProAQT Sensor

Applicant Pulsion Medical Systems SE

K-Number K192169

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FRG 2020-04-30

Turbett Instrument Pod

Applicant Turbett Surgical, Inc.

K-Number K200240

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