Biopsybell S.R.L.
Biopsybell S.R.L. holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2023, with 19 FDA device recalls on record.
Top product codes for Biopsybell S.R.L.
FDA recalls by Biopsybell S.R.L.
10 most recent of 19- Z-1639-2021 — 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
- Z-1636-2021 — EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
- Z-1631-2021 — BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
- Z-1641-2021 — 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
- Z-1632-2021 — RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
- Z-1649-2021 — 10 GAUGE DRILL, CODE INTVM-DRL
- Z-1645-2021 — 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
- Z-1646-2021 — 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
- Z-1634-2021 — BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
- Z-1643-2021 — 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Biopsybell S.R.L.
- K231340 — Renova Spine Balloon Catheter
- K203397 — Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
- K180315 — DISKOM
- K130616 — MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
Data sourced from openFDA. This site is unofficial and independent of the FDA.