510(k) K001808 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
DORO HEADREST SYSTEM
| Applicant | Pro-Med Instruments GmbH, Roswell GA, US |
| Decision | Substantially Equivalent, Aug 4, 2000 |
| Received | Jun 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2025 | Pro-Med Instruments Gmbh DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) Open, Classified |
HBL | None listed |
| Nov 2, 2017 | Pro-Med Instruments Gmbh pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY
The DORO(R) Skull Pins are inserted into the receptacles of th Terminated |
HBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.