Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Biopsybell with 19 device recalls and 7 510(k) clearances. The most recent is a 510(k) clearance dated Oct 30, 2023: Renova Spine Balloon Catheter.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 30, 2023 | Renova Spine Balloon CatheterK231340 · NDN | 510(k) clearances |
| Mar 22, 2021 | BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing systemClass II · Products labeled as sterile were distributed, but may not have been sterilized. | Device recalls |
| Mar 22, 2021 | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDKClass II · Products labeled as sterile were distributed, but may not have been sterilized. | Device recalls |
| Mar 22, 2021 | 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAKClass II · Products labeled as sterile were distributed, but may not have been sterilized. | Device recalls |
| Mar 22, 2021 | CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051Class II · Products labeled as sterile were distributed, but may not have been sterilized. | Device recalls |
| Mar 22, 2021 | RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-USClass II · Products labeled as sterile were distributed, but may not have been sterilized. | Device recalls |
| Mar 22, 2021 | 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAKClass II · Products labeled as sterile were distributed, but may not have been sterilized. | Device recalls |
| Mar 22, 2021 | BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111Class II · Products labeled as sterile were distributed, but may not have been sterilized. | Device recalls |
| Mar 22, 2021 | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBDClass II · Products labeled as sterile were distributed, but may not have been sterilized. | Device recalls |
| Jan 11, 2021 | 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/10cmK203397 · KNW | 510(k) clearances |
| Mar 26, 2018 | DISKOMK180315 · HRX | 510(k) clearances |
| Feb 7, 2014 | MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLESK130616 · KNW | 510(k) clearances |
| Aug 17, 2001 | SPEEDYBELLK010735 · KNW | 510(k) clearances |
| Jun 27, 2001 | EASYBELLK011075 · FCG | 510(k) clearances |
| May 31, 2001 | OSTEOBELLK011104 · KNW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
