Company ยท IT
BIOPSYBELL S.R.L.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2023. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
19recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 30, 2023 | K231340 | Renova Spine Balloon Catheter Biopsybell S.R.L., IT | NDN |
| Jan 11, 2021 | K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- Biopsybell S.R.L., IT | KNW |
| Mar 26, 2018 | K180315 | DISKOM Biopsybell S.R.L., IT | HRX |
| Feb 7, 2014 | K130616 | MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES Biopsybell S.R.L. | KNW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2021 | BIOPSYBELL S.R.L. 10 GAUGE DRILL, CODE INTVM-DRL Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15 Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111 Terminated |
KNW | K130616 |
| May 19, 2021 | BIOPSYBELL S.R.L. BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system Terminated |
LOD | None listed |