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

LZA 2022-03-18

Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs

Applicant Shandong Blue Sail Health Technology Co., Ltd.

K-Number K220228

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FLL 2022-03-18

Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)

Applicant Sichuan Youkede Medical Equipment Co.,Ltd

K-Number K210171

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BWK 2022-03-18

Needle Stimulator (Model: RJNS6-1)

Applicant Bozhou Rongjian Medical Appliance Co., Ltd.

K-Number K220153

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BZD 2022-03-18

F&P Evora Full Face Mask

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K212371

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MTD 2022-03-18

OPTRELL Mapping Catheter with TRUEref Technology

Applicant Biosense Webster, Inc.

K-Number K211438

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GEI 2022-03-18

TempSure System

Applicant Cynosure, LLC

K-Number K212891

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FYA 2022-03-18

Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

Applicant Dukal Corporation

K-Number K203237

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DQX 2022-03-18

Cardio Flow Peripheral Guide Wire

Applicant Cardio Flow Inc.,

K-Number K213834

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KWQ 2022-03-18

EMERGE Anterior Cervical Plate System

Applicant Evolution Spine

K-Number K220275

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FRC 2022-03-18

CELERITY 20 HP Challenge Pack

Applicant Steris

K-Number K220473

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OWB 2022-03-18

SURGIVISIO Device

Applicant Ecential Robotics

K-Number K220627

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KWI 2022-03-18

DePuy Synthes Radial Head Replacement System

Applicant DePuy Synthes

K-Number K213563

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