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

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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MXD 2021-06-11

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

Applicant Medtronic, Inc.

K-Number K210484

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IYE 2021-06-10

Fiducial Marker

Applicant Carbon Medical Technologies, Inc.

K-Number K211590

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HEB 2021-06-10

Callaly Tampliner

Applicant Calla Lily Personal Care, Ltd.

K-Number K211469

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IYN 2021-06-10

Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K210699

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LYZ 2021-06-10

Disposable Vinyl Examination Gloves

Applicant Shandong Shengshixincheng Medical Science & Technology Co.,

K-Number K210522

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