FDA Device Registration & Listing · Burlington, NC, US · Registration 3008925277
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2025-01-10 |
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | Class 2 | 884.5470 | 2025-01-10 |
| JEW | Tip, Rubber, Oral Hygiene | Dental | Class 1 | 872.6650 | 2025-01-10 |
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | Class 2 | 884.5470 | 2025-01-10 |
| JEQ | Toothbrush, Powered | Dental | Class 1 | 872.6865 | 2025-01-10 |
| LCN | Scraper, Tongue | Dental | Class 1 | 872.6855 | 2025-01-10 |
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | Class 1 | 876.5920 | 2025-01-10 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | General, Plastic Surgery | Class 2 | 878.4810 | 2025-01-10 |
| OHT | Light Based Over-The-Counter Hair Removal | General, Plastic Surgery | Class 2 | 878.4810 | 2025-01-10 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2025-01-10 |
| EFT | Cleanser, Denture, Over The Counter | Dental | Class 1 | 872.3520 | 2025-01-10 |
| JEQ | Toothbrush, Powered | Dental | Class 1 | 872.6865 | 2025-01-10 |
| NRC | Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | Obstetrics/Gynecology | Class 1 | 884.5425 | 2025-01-10 |
| KOO | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | Dental | Class 1 | 872.3490 | 2025-01-10 |
| JEQ | Toothbrush, Powered | Dental | Class 1 | 872.6865 | 2025-01-10 |
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | Class 2 | 884.5470 | 2025-01-10 |
| QKP | Coronavirus Antigen Detection Test System. | Unknown | Class N | N/A | 2025-01-13 |
| JET | Pick, Massaging | Dental | Class 1 | 872.6650 | 2025-01-10 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2025-01-10 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004069780 | Ryder Integrated Logistics, INC | Burlington, NC, US |
| 3012133441 | Ryder Integrated Logistics, INC | Wilmer, TX, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K973236 | Procter & Gamble Co. | CREST TOOTHBRUSH WITH MICROSHIELD | 1998-03-11 |
| K923985 | Personal Products Co. | UNSCENTED MENSTRUAL TAMPON | 1993-02-19 |
| K151170 | Tosama, D.O.O. | Tosama 100% Organic Cotton Menstrual Tampon | 2015-07-02 |
| K930149 | Kimberly-Clark Corp. | KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+ | 1994-03-02 |
| K192521 | Shangdong Huamei Technology Co., Ltd. | Intense Pulsed Light Treatment System | 2019-12-06 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0005-2014 | PhotoMedex, Inc. | 2 | The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***.
The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081.
Indicated for the incision, excision, coagulations, and vaporization of soft tissue. |
| Z-0025-2018 | Medtronic Navigation, Inc. | 2 | VCLAS (Visualase Cooled Laser Ablation System)
Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;
Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip;
Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip |
| Z-0028-2007 | Lumenis Inc. | 2 | Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue.
Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA |
| Z-0001-2023 | Jiangsu Well Biotech Co., Ltd. No | N | Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 |
| Z-0032-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3006149964 | POWERLINK CREATIONS (ZHONGSHAN) CORPORATION | Zhongshan Guangdong, CN |
| 3002762071 | EBNAT AG | Ebnat-Kappel Sankt Gallen, CH |
| 3026482909 | WALDKRAFT GMBH | Todtnau Baden-Wurttemberg, DE |
| 3015913483 | GRAND S KOREA CO., LTD. | Goyang-si Gyeonggi, KR |
| 3043840120 | CURIDENT, LLC | Boca Raton, FL, US |
3008925277 when referencing this establishment in official correspondence.