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

GZF 2022-02-23

StimRouter Neuromodulation System

Applicant Bioness, Inc.

K-Number K211965

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NEW 2022-02-22

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture

Applicant ETHICON, Inc.

K-Number K212380

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FLE 2022-02-22

Enbio S

Applicant Enbio Group AG

K-Number K213991

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PLV 2022-02-22

INLIANT Surgical Navigation System

Applicant Navigate Surgical Technologies, Inc.

K-Number K213392

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FGB 2022-02-22

Flexible Video-Choledo-Cysto-Ureteroscope System

Applicant Shanghai SeeGen Photoelectric Technology Co., Ltd.

K-Number K211686

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EBZ 2022-02-22

VALO X, VALO X Accessory Lenses

Applicant Ultradent Products, Inc.

K-Number K220471

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LZA 2022-02-21

TMG Nitrile Powder Free Examination Glove

Applicant Thai Medical Glove Co., Ltd.

K-Number K213500

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LZA 2022-02-21

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy

Applicant Mercator Medical (Thailand), Ltd.

K-Number K213548

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FYA 2022-02-21

EndoArmor + Surgical Gown

Applicant Boston Scientific Corporation

K-Number K203548

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LZA 2022-02-20

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange

Applicant Megine Industries Sdn Bhd

K-Number K220232

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FXX 2022-02-20

Medical Surgical Mask

Applicant Hunan Zhenheyikang Medical Instrument Co., Ltd.

K-Number K213724

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FXX 2022-02-19

Surgical Face Mask

Applicant Taiwan Comfort Champ Manufacturing Co., Ltd.

K-Number K212863

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