FDA Registration
Active
🇺🇸 United States
DEL MEDICAL, INC.
Reg #: 1418964
·
FEI: 1418964
·
Expires 2026
Products
13
Proprietary Names
53
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- DEL MEDICAL, INC.
- Registration Number
- 1418964
- FEI Number
- 1418964
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 241 Covington Dr
- City
- Bloomingdale
- State
- IL
- ZIP
- 60108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121838
Owner / Operator
- Firm Name
- Del Medical, Inc
- Operator Number
- 10031137
- Address
- 241 Covington Drive
- City
- Bloomingdale
- State
- IL
- Postal Code
- 60108
- Country
- US
- Correspondent
- George Bell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2024-07-25 |
| Collimator, Automatic, Radiographic | IZW | Class 2 | Radiology | No | 2026-03-30 |
| Tube Mount, X-Ray, Diagnostic | IYB | Class 1 | Radiology | No | 2009-12-23 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2023-04-26 |
| Table, Radiographic, Non-Tilting, Powered | IZZ | Class 2 | Radiology | No | 2009-12-23 |
| Collimator, Manual, Radiographic | IZX | Class 2 | Radiology | No | 2018-10-10 |
| Grid, Radiographic | IXJ | Class 1 | Radiology | No | 2015-05-06 |
| Table, Cystometric, Non-Electric And Accessories | KQS | Class 1 | Gastroenterology, Urology | No | 2024-07-26 |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | Class 1 | Radiology | No | 2009-12-23 |
| Table, Radiologic | KXJ | Class 2 | Radiology | No | 2017-01-31 |
| System, X-Ray, Mobile | IZL | Class 2 | Radiology | No | 2018-06-11 |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | Class 1 | Radiology | No | 2009-12-23 |
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | Class 1 | Radiology | No | 2013-12-24 |
Proprietary Names
Hydra Vision
AL02
R225
FWFC (non-rotate)
FMT
OTC18M
OTC18T
OTC18S
FMT18M
FWFC (rotate)
FMT18T
FM-FMT18T
FM-FMT18M
DM-FMT18T
FM-OTC18M
DM-OTC18M
DMX
DM-FWFC
CM-OTC18M
DM-FMT18M
FM-OTC18T
DM-OTC18S
DM-OTC18T
DM-FMT
CM-OTC18T
DelWorks
MT500-EL
EV800
EV800T
MT500-EB
RT100
ML03
R221
RB100
VT300 (5187)
VT300 (5150)
UARM
VS300
VT300T
VS100
VS50
VT300 (5157)
SARM
MT500-F
MT500
KA Reveal Mobi Pro
MDR
Anthem 40-500
Anthem 30-400
Anthem 50-650
Anthem 32-500
Anthem 40-600
Assembly Tube
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device