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

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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OUR 2021-02-25

iFuse-TORQ Implant System

Applicant SI-BONE, Inc.

K-Number K203247

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GZJ 2021-02-24

BioWaveGO RX

Applicant Biowave Corporation

K-Number K210202

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QEW 2021-02-24

Triever Catheters

Applicant Inari Medical

K-Number K210195

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LZA 2021-02-24

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

Applicant Gmp Medicare Sdn. Bhd.

K-Number K202003

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HRS 2021-02-24

ExtremiLOCK Lateral Ankle Fusion Plates

Applicant Osteomed

K-Number K203479

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EKX 2021-02-24

PROXEO Twist Cordless Polishing System PL-40 H

Applicant W&H Dentalwerk Buermoos GmbH

K-Number K201703

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OLO 2021-02-24

Practical Navigation Surgical Guidance System (PNSGS)

Applicant Practical Navigation, LLC

K-Number K202184

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