FDA Registration
Active
🇺🇸 United States
THERMEDX, LLC
Reg #: 3007495879
·
FEI: 3007495879
·
Expires 2026
Products
4
Proprietary Names
11
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- THERMEDX, LLC
- Registration Number
- 3007495879
- FEI Number
- 3007495879
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 31200 Solon Road, Unit 1
- City
- Solon
- State
- OH
- ZIP
- 44139
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133799
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubing And Tubing/Filter Fits | NVT | Class 1 | Obstetrics/Gynecology | No | 2025-06-27 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2022-04-21 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2022-04-21 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2022-04-21 |
Proprietary Names
P01790 ThermaClear Inflow Tube Set
LL0004 FluidSmart Inflow/Outflow Tube Set
P01918 ThermaClear Scope Outflow Tube Set
LL0002 FluidSmart Inflow Tube Set
LL0006 FluidSmart Urology Tube Set
P2000 FluidSmart Fluid Management system (at the time of clearance, this was called Thermedx Fluid Management System
LL0002 Luer Lock Set Single Lumen
LL0004 - Tubing Set Single Lumen Inflow with Dual Outflow
LL0006 - Urology Set
P2000 FluidSmart Fluid Management system
P2000 FluidSmart Fluid Management system (at the time of clearance, this was called Thermedx 37-5)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198