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

LOX 2021-04-29

KardiFlex PTCA Balloon Dilatation Catheter

Applicant Medcaptain Life Science Co., Ltd.

K-Number K202619

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LZA 2021-04-29

Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)

Applicant Harbour Health, LLC

K-Number K210944

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FDF 2021-04-29

Pure Vu System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K210981

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EOQ 2021-04-29

Rescue Pulmonary Grasping Forceps

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K-Number K202987

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MQB 2021-04-28

1717FCC

Applicant Rayence Co., Ltd.

K-Number K210985

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DXN 2021-04-28

CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor

Applicant Contec Medical Systems Co.,Ltd

K-Number K202757

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LZA 2021-04-28

Disposable Nitrile Examination Gloves

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K203436

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GDW 2021-04-28

Titan SGS

Applicant Standard Bariatrics

K-Number K210278

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LNH 2021-04-28

TCL3 Motion Tracking System

Applicant Tracinnovations Aps

K-Number K203451

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DQY 2021-04-28

Plato 17 Microcatheter

Applicant Scientia Vascular, LLC

K-Number K210601

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NUC 2021-04-28

Astroglide X Silicone Personal Lubricant

Applicant Biofilm, Inc.

K-Number K210242

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LZO 2021-04-28

BI-MENTUM ALTRX® Dual Mobility Liner

Applicant Depuy Ireland UC

K-Number K203532

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