BIOPSYBELL S.R.L.
FDA Regulatory Profile
BIOPSYBELL S.R.L. appears in FDA public data with 19 recalls, 7 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1632-2021, Class II) was initiated on March 22, 2021. Its most recent 510(k) clearance was granted on October 30, 2023.
Summary
- Total Recalls
- 19
- 510(k) Clearances
- 7
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1632-2021 | Class II | RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US | March 22, 2021 |
| Z-1641-2021 | Class II | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK | March 22, 2021 |
| Z-1648-2021 | Class II | 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC | March 22, 2021 |
| Z-1634-2021 | Class II | BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111 | March 22, 2021 |
| Z-1639-2021 | Class II | 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK | March 22, 2021 |
| Z-1636-2021 | Class II | EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS | March 22, 2021 |
| Z-1631-2021 | Class II | BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system | March 22, 2021 |
| Z-1649-2021 | Class II | 10 GAUGE DRILL, CODE INTVM-DRL | March 22, 2021 |
| Z-1645-2021 | Class II | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB | March 22, 2021 |
| Z-1635-2021 | Class II | CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 | March 22, 2021 |
| Z-1646-2021 | Class II | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK | March 22, 2021 |
| Z-1643-2021 | Class II | 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD | March 22, 2021 |
| Z-1647-2021 | Class II | 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15 | March 22, 2021 |
| Z-1644-2021 | Class II | 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK | March 22, 2021 |
| Z-1640-2021 | Class II | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB | March 22, 2021 |
| Z-1642-2021 | Class II | CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS | March 22, 2021 |
| Z-1633-2021 | Class II | BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US | March 22, 2021 |
| Z-1638-2021 | Class II | 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC | March 22, 2021 |
| Z-1637-2021 | Class II | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD | March 22, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231340 | Renova Spine Balloon Catheter | October 30, 2023 |
| K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, | January 11, 2021 |
| K180315 | DISKOM | March 26, 2018 |
| K130616 | MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES | February 7, 2014 |
| K010735 | SPEEDYBELL | August 17, 2001 |
| K011075 | EASYBELL | June 27, 2001 |
| K011104 | OSTEOBELL | May 31, 2001 |