Black Forest Medical GmbH
FREIBURG Baden-Wurttemberg, DE
Black Forest Medical GmbH appears in FDA device records in FREIBURG Baden-Wurttemberg, DE. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Black Forest Medical GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Pro-Med Instruments GmbH510(k), enforcement report, recall
510(k) clearance history
FDA records hold 10 510(k) clearances for Black Forest Medical GmbH between 2000 and 2024. The busiest year on record is 2007, with 2. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2003 | 1 |
| 2007 | 2 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) | HBL | Substantially Equivalent | |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | HBL | Substantially Equivalent | |
| K203505 | DORO QR3 Headrest System (Aluminum) | HBL | Substantially Equivalent | |
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | HBL | Substantially Equivalent | |
| K191740 | DORO LUCENT® iXI and iMRI Headrest System | HBL | Substantially Equivalent | |
| K191979 | DORO QR3 XTom Headholder System | HBL | Substantially Equivalent | |
| K063494 | DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS | HBL | Substantially Equivalent | |
| K070997 | DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX | GEI | Substantially Equivalent | |
| K032331 | DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) | HBL | Substantially Equivalent | |
| K001808 | DORO HEADREST SYSTEM | HBL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003923584 | 3003923584 | Black Forest Medical GmbH | BOETZINGER STRASSE 86, FREIBURG Baden-Wurttemberg 79111 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1860-2025 | DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) | Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded. | Class II | Open, Classified | |
| Z-2972-2018 | DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. | Class I | Terminated | |
| Z-2971-2018 | DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. | Class I | Terminated | |
| Z-2970-2018 | DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. | Class I | Terminated | |
| Z-0193-2018 | 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 the skull clamp and fixate the head during surgery. | The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain