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

MYN 2022-09-20

Aorta-CAD

Applicant Imagen Technologies, Inc.

K-Number K213353

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LZA 2022-09-20

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Mezorrison Medical Technology (Dongying) Co., Ltd.

K-Number K214056

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LZA 2022-09-20

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)

Applicant Inner Mongolia Cureguard Medical Technology Co., Ltd.

K-Number K222642

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DZE 2022-09-19

NB 1 SA Implant System

Applicant Arum Dentistry Co., Ltd.

K-Number K222131

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QNQ 2022-09-19

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe

Applicant Jeil Tech Co., Ltd.

K-Number K213013

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HWC 2022-09-19

Arthrex Compression FT Pins

Applicant Arthrex, Inc.

K-Number K220839

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EKX 2022-09-19

Pro M Class

Applicant Saeyang Microtech Co., Ltd.

K-Number K213897

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PGY 2022-09-19

C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K222121

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EOB 2022-09-19

Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3

Applicant Olympus Medical Systems Corp.

K-Number K221638

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FMI 2022-09-19

Promisemed X-Safety Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K220129

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FMK 2022-09-19

Lancet

Applicant Hebei Xinle Sci&Tech Co., Ltd.

K-Number K221839

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FYA 2022-09-19

35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown

Applicant Winner Medical Co., Ltd.

K-Number K221819

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