FDA Registration
Active
🇺🇸 United States
DORNIER MEDTECH AMERICA, INC.
Reg #: 1037955
·
FEI: 1037955
·
Expires 2026
Products
19
Proprietary Names
9
Establishment Types
3
Classifications
19
Registration Details
- Registration Name
- DORNIER MEDTECH AMERICA, INC.
- Registration Number
- 1037955
- FEI Number
- 1037955
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1155 ROBERTS BLVD.
- City
- KENNESAW
- State
- GA
- ZIP
- 30144
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243497
Owner / Operator
- Firm Name
- Dornier MedTech America, Inc.
- Operator Number
- 1037955
- Address
- 1155 ROBERTS BLVD., Suite 100
- City
- Kennesaw
- State
- GA
- Postal Code
- 30144
- Country
- US
- Correspondent
- John - Hoffer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2025-08-07 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2025-02-12 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2022-10-17 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2022-11-21 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2013-06-07 |
| Dislodger, Stone, Flexible | FGO | Class 2 | Gastroenterology, Urology | No | 2018-10-29 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2020-06-16 |
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | Class 2 | Gastroenterology, Urology | No | 2023-03-22 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2024-06-27 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2024-06-27 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2024-06-27 |
| Dilator, Catheter, Ureteral | EZN | Class 2 | Gastroenterology, Urology | No | 2020-01-27 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2020-01-27 |
| Catheter, Ureteral, Gastro-Urology | EYB | Class 2 | Gastroenterology, Urology | No | 2020-01-27 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2025-02-21 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2026-06-12 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2020-01-27 |
| Stylet, Ureteral | EYA | Class 1 | Gastroenterology, Urology | No | 2018-10-29 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-02-21 |
Proprietary Names
Medilas H RFID Laser Fibers
Medilas H Solvo 35 Laser
Medilas H Ball Tip Laser Fiber
Medilas H RFID Laser Fiber
Thulio
Medilas H Slim Laser Fiber
DORNIER MEDILAS H
Dornier MedTech America, Inc. MAGELLAN Access Sheath
Nautilus
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility