FDA Device Registration & Listing · York, PA, US · Registration 3008502431
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EYB | Catheter, Ureteral, Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.5130 | 2025-01-03 |
| GBM | Catheter, Urethral | Gastroenterology, Urology | Class 2 | 876.5130 | 2023-01-31 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2024-01-24 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | Class 2 | 876.5250 | 2024-01-23 |
| EZD | Catheter, Straight | Gastroenterology, Urology | Class 2 | 876.5130 | 2026-02-02 |
| MUI | Media, Coupling, Ultrasound | Radiology | Class 2 | 892.1570 | 2018-07-10 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2024-01-23 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2022-07-26 |
| KMJ | Lubricant, Patient | General Hospital | Class 1 | 880.6375 | 2010-05-28 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2024-01-23 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2024-01-23 |
| OHR | Catheter Care Tray | Gastroenterology, Urology | Class 2 | 876.5130 | 2024-03-20 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2025-09-11 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2024-01-23 |
| MMS | Lubricant, Vaginal, Patient | General Hospital | Class 1 | 880.6375 | 2010-05-28 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2024-01-23 |
| EYJ | Holder, Ureteral Catheter | Gastroenterology, Urology | Class 1 | 876.5130 | 2022-12-07 |
| FCE | Enema Kit | Gastroenterology, Urology | Class 1 | 876.5210 | 2023-08-18 |
| EXD | Irrigator, Ostomy | Gastroenterology, Urology | Class 2 | 876.5895 | 2023-08-18 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2020-04-29 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2024-01-04 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K150256 | Argentum Medical | SILVERLON BURN CONTACT DRESSINGS | 2015-04-30 |
| K791969 | Medline Industries, Inc. | DYNACOR STERILE CLOSED SYS. DRAINAGE BAG | 1979-11-05 |
| K233013 | Silq Technologies Corporation | 2-Way 100% Silicone Cleartract Catheter | 2024-01-23 |
| K033719 | C.R. Bard, Inc. | BARD TIGERTAIL URETERAL CATHETER | 2004-02-04 |
| K820239 | American Endoscopy, Inc. | RETRIEVAL FORCEPS | 1982-03-26 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0012-2023 | Hobbs Medical, Inc. | 2 | Hobbs Medical Flex-Ez Guide Wire
Disposable For endoscopy procedures
Ref: 3412 |
| Z-0003-06 | B. Braun Medical, Inc. | U | D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage. |
| Z-0038-2025 | 3M Company Health Care Business 3m Center | U | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R |
| Z-0004-2013 | Cure Medical LLC | 2 | Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches).
There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539
The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder. |
| Z-0010-2013 | C.R. Bard, Inc., Urological Division | 2 | 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004070478 | URO TECHNOLOGY SDN. BHD. | PONTIAN Johor, MY |
| 3009051888 | Applied Medical Distribution Center | Irvine, CA, US |
| 1000393132 | COOK INCORPORATED | ELLETTSVILLE, IN, US |
| 1825146 | Cook Incorporated | Spencer, IN, US |
| 3010155661 | Synergy Health Sterilisation UK Ltd | Thorne Doncaster, GB |
3008502431 when referencing this establishment in official correspondence.