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

FLL 2021-02-25

Infrared Forehead Thermometer

Applicant Conmo Electronic Company Limited

K-Number K202420

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PAY 2021-02-25

STOP U Model UXV Device

Applicant Pollogen, Ltd.

K-Number K203665

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LLZ 2021-02-25

NinesMeasure

Applicant Nines, Inc.

K-Number K202990

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MUA 2021-02-25

EchoS Family

Applicant Echolight S.P.A

K-Number K202514

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NQQ 2021-02-25

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

Applicant Perimeter Medical Imaging Ai, Inc.

K-Number K203578

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GEI 2021-02-25

Tixel System

Applicant Novoxel , Ltd.

K-Number K202988

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IYN 2021-02-25

SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K201969

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FXX 2021-02-25

Disposable Surgical Mask/Fluid Resistant Procedure Mask

Applicant Lhm Medical Technology (Hong Kong) Limited

K-Number K202240

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KCT 2021-02-25

KARL STORZ UDEL Sterilization Trays

Applicant Karl Storz Endoscopy America, Inc.

K-Number K201945

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FLL 2021-02-25

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C

Applicant Hetaida Technology Co., Ltd.

K-Number K203332

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IYN 2021-02-25

SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K201971

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DQY 2021-02-25

Phenom Catheters

Applicant Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

K-Number K210230

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