510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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|---|---|---|---|
| digital blood pressure monitor wbp series | Weony (Shenzhen) Technology Co., Ltd. | k231542 |
09/07/2023 |
| dimension cyclosporine extended range calibrator (dc108a) | DADE BEHRING, INC. | k061503 |
06/22/2006 |
| diode laser therapy device | Hebei Zhemai Technology Co., Ltd | k232709 |
11/30/2023 |
| diode laser therapy systems | BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD | k152898 |
02/09/2016 |
| discoscopes, cervical endoscopes | RZ MEDIZINTECHNIK GMBH | k130778 |
04/14/2014 |
| discovery pet/ct 710 | GE MEDICAL SYSTEMS, LLC | k133657 |
03/21/2014 |
| disk | AMERICAN HEARTLINE, INC. | k812695 |
10/13/1981 |
| disposable intra-articular blade | CONCEPT, INC. | k830434 |
04/12/1983 |
| disposable nitrile examination gloves (tested for use with chemotherapy drugs) - blue/black/purple | Jiangsu Bytech Medical Supplies Co.,Ltd. | k220382 |
04/21/2022 |
| disposable standard clamp | Standard Bariatrics | k190788 |
04/18/2019 |
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