Pro-Med Instruments Gmbh
FDA Regulatory Profile
Summary
- Total Recalls
- 5 (3 Class I)
- 510(k) Clearances
- 4
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1860-2025 | Class II | DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) | March 14, 2025 |
| Z-2970-2018 | Class I | DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and | July 5, 2018 |
| Z-2971-2018 | Class I | DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and | July 5, 2018 |
| Z-2972-2018 | Class I | DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percut | July 5, 2018 |
| Z-0193-2018 | Class II | pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 | November 2, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K063494 | DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS | May 21, 2007 |
| K070997 | DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-X | May 16, 2007 |
| K032331 | DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM | November 20, 2003 |
| K001808 | DORO HEADREST SYSTEM | August 4, 2000 |