FDA device listing
and Horseshoe Headrests,DORO®,DORO® Base Unit Radiolucent,DORO® Headrest System Radiolucent,DORO® Radiolucent Headrest…
FDA device listing 1610987686 · Black Forest Medical GmbH
Key facts
| Proprietary names | and Horseshoe Headrests,DORO®,DORO® Base Unit Radiolucent,DORO® Headrest System Radiolucent,DORO® Radiolucent Headrest System,DORO® Transitional Member Radiolucent,J-Arm Retractor System |
|---|---|
| Owner/operator | Black Forest Medical GmbH |
| Owner/operator number | 9041863 |
| Premarket submissions | K032331 |
| Product codes | HBL |
| Device names | HBL - Holder, Head, Neurosurgical (Skull Clamp) |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4460 |
| Review panels | Neurology |
| Registered establishments | Black Forest Medical GmbH, BLACK FOREST MEDICAL NORTH AMERICA, INC. |
| Establishment registrations | 3003923579, 3003923584 |
| FEI numbers | 3003923579, 3003923584 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database