Company · DE
Pro Med Instruments GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2024. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 2024 | K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainl Pro Med Instruments GmbH, DE | HBL |
| Apr 24, 2024 | K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) Pro Med Instruments GmbH, DE | HBL |
| Mar 29, 2021 | K203505 | DORO QR3 Headrest System (Aluminum) Pro Med Instruments GmbH, DE | HBL |
| Jun 2, 2020 | K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) Pro Med Instruments GmbH, DE | HBL |
| Feb 21, 2020 | K191740 | DORO LUCENT® iXI and iMRI Headrest System Pro Med Instruments GmbH, DE | HBL |
| Oct 22, 2019 | K191979 | DORO QR3 XTom Headholder System Pro Med Instruments GmbH, DE | HBL |
| May 21, 2007 | K063494 | DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS Pro-Med Instruments GmbH | HBL |
| May 16, 2007 | K070997 | DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX Pro-Med Instruments GmbH | GEI |
| Nov 20, 2003 | K032331 | DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) Pro-Med Instruments GmbH | HBL |
| Aug 4, 2000 | K001808 | DORO HEADREST SYSTEM Pro-Med Instruments GmbH | HBL |
Latest recalls
| 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 | K001808 |
| 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 | K032331 |
| 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 | K032331 |
| 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 | K032331 |
| 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 | K001808 |