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

LZA 2021-06-13

Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Ansell Healthcare Products, LLC

K-Number K210401

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FLL 2021-06-11

Radius T wearable thermometer

Applicant Masimo Corporation

K-Number K203215

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FRA 2021-06-11

EOS Air Cleaner

Applicant Guangzhou Ajax Medical Equipment Co., Ltd.

K-Number K202766

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EMA 2021-06-11

PANAVIA Veneer LC

Applicant Kuraray Noritake Dental, Inc.

K-Number K210504

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KGO 2021-06-11

POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K203030

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NUC 2021-06-11

Replens Long-Lasting Vaginal Moisturizer

Applicant Church & Dwight Co., Inc.

K-Number K203818

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NCB 2021-06-11

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants

Applicant Fci (France Chirurgie Instrumentation) Sas

K-Number K203569

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NUH 2021-06-11

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H

Applicant Shenzhen Osto Technology Company Limited

K-Number K210756

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IYE 2021-06-11

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

Applicant Elekta Limited

K-Number K210500

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QPL 2021-06-11

Axon Therapy

Applicant Neuralace Medical, Inc.

K-Number K210021

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FXX 2021-06-11

Surgical Face Mask

Applicant Zhuhai Gaoge Medical Technology Co., Ltd.

K-Number K203732

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FXX 2021-06-11

Medical Face Mask

Applicant Chongqing Chaoke Industry Development Co., Ltd.

K-Number K202714

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