510(k) K032331 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
| Applicant | Pro-Med Instruments GmbH, Alva FL, US |
| Decision | Substantially Equivalent, Nov 20, 2003 |
| Received | Jul 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032331
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2018 | Pro-Med Instruments Gmbh DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries Terminated |
HBL | None listed |
| Sep 17, 2018 | Pro-Med Instruments Gmbh DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries Terminated |
HBL | None listed |
| Sep 17, 2018 | Pro-Med Instruments Gmbh DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries Terminated |
HBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.