FDA Device Registration & Listing · Hanoi Ha Noi, VN · Registration 3018507299
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2020-05-18 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-06-16 |
| EMB | Zinc Oxide Eugenol | Dental | Class 1 | 872.3275 | 2018-04-25 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-08-11 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2016-08-11 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2018-09-21 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-06-16 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-06-16 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-04-28 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2023-08-29 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-10-26 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2020-01-05 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-06-22 |
| EHJ | Disk, Abrasive | Dental | Class 1 | 872.6010 | 2016-06-22 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2022-04-13 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2022-04-13 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-05-05 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-06-16 |
| KGC | Tube, Gastro-Enterostomy | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-05-01 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2025-05-30 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2025-02-25 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2026-05-28 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2026-05-28 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2019-06-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-10-26 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2017-11-14 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2026-02-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-06-16 |
| FON | Bag, Drainage, With Adhesive, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2022-03-28 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2019-07-02 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2025-02-25 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-02-25 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2026-02-18 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K812404 | Nu Tech Medical Systems | BUTTERFLY NEEDLE ASSEMBLY | 1981-09-09 |
| K020499 | Jeneric/Pentron, Inc. | BOND-3 ADHESIVE | 2002-04-22 |
| K801093 | Dentsply Intl. | PRISMA-BOND | 1980-05-20 |
| K061981 | Apex Dental Materials, Inc. | SURPASS | 2006-07-31 |
| K110302 | 3M Espe AG | ADHESIVE EXL-759 | 2011-05-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2024 | Bard Peripheral Vascular Inc | 2 | Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 |
| Z-0044-2018 | Bard Peripheral Vascular Inc | 2 | BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm.
The core needle biopsy device is intended for use in obtaining biopsies from soft tissues. |
| Z-0002-2022 | Bard Peripheral Vascular Inc | 2 | REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796 |
| Z-0035-2008 | Heraeus Kulzer Inc., Dental Products Division | 2 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710. |
| Z-0036-2008 | Heraeus Kulzer Inc., Dental Products Division | 2 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3027338968 | RONCADELLE OPERATIONS SRL | Castel Mella Brescia, IT |
| 3000214934 | ALMAC PHARMA SERVICES LLC | Audubon, PA, US |
| 3006850123 | JAPAN IRRADIATION SERVICE CO., LTD | Naka-gun Ibaraki, JP |
| 3029328631 | PEGASUS IMPORTS | Houston, TX, US |
| 3010621964 | ATLAS MEDICAL PRODUCTS LLC | Hialeah, FL, US |
3018507299 when referencing this establishment in official correspondence.