FDA Device Registration & Listing · Wilmer, TX, US · Registration 3012133441
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | Class 2 | 884.5470 | 2025-01-10 |
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | Class 1 | 876.5920 | 2025-01-10 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2025-01-10 |
| JET | Pick, Massaging | Dental | Class 1 | 872.6650 | 2025-01-10 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | Obstetrics/Gynecology | Class 2 | 884.5460 | 2025-01-10 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | Obstetrics/Gynecology | Class 2 | 884.5460 | 2025-01-10 |
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | Class 2 | 884.5470 | 2025-01-10 |
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | Class 2 | 884.5470 | 2025-01-10 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2025-01-10 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2025-01-10 |
| EFT | Cleanser, Denture, Over The Counter | Dental | Class 1 | 872.3520 | 2025-01-10 |
| JEW | Tip, Rubber, Oral Hygiene | Dental | Class 1 | 872.6650 | 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 |
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | Class 2 | 884.5470 | 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 |
| 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 |
| EFS | Unit, Oral Irrigation | Dental | Class 1 | 872.6510 | 2025-01-10 |
| KMT | Tray, Fluoride, Disposable | Dental | Class 1 | 872.6870 | 2025-01-10 |
| JEQ | Toothbrush, Powered | Dental | Class 1 | 872.6865 | 2025-01-10 |
| KOO | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | Dental | Class 1 | 872.3490 | 2025-01-10 |
| LCN | Scraper, Tongue | Dental | Class 1 | 872.6855 | 2025-01-10 |
| JEQ | Toothbrush, Powered | Dental | Class 1 | 872.6865 | 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 |
| 3008925277 | Ryder Integrated Logistics, INC | Burlington, NC, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| 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 |
| K973236 | Procter & Gamble Co. | CREST TOOTHBRUSH WITH MICROSHIELD | 1998-03-11 |
| K821629 | Moyco Industries, Inc. | FIXIDENT | 1982-06-14 |
| 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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3030979401 | Everylife Inc | West Palm Beach, FL, US |
| 3038282948 | CORDIS LOGISTICS SP. Z O.O. | Radomsko Lodzkie, PL |
| 3010692191 | Ontex BV | Buggenhout Oost-Vlaanderen, BE |
| 3011964664 | PROCTER & GAMBLE DISTRIBUTING LLC, THE | Union, OH, US |
| 3014833751 | NC - Albaad Fem US | Kernersville, NC, US |
3012133441 when referencing this establishment in official correspondence.