Biopsybell S.r.l.
MIRANDOLA Modena, IT
BIOPSYBELL S.R.L. appears in FDA device records in MIRANDOLA Modena, IT. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 19 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Biopsybell S.r.l. between 2014 and 2023. The busiest year on record is 2014, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231340 | Renova Spine Balloon Catheter | NDN | Substantially Equivalent | |
| 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 | KNW | Substantially Equivalent | |
| K180315 | DISKOM | HRX | Substantially Equivalent | |
| K130616 | MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES | KNW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617616 | 3003272754 | BIOPSYBELL S.R.L. | Via A.Manuzio n.24, MIRANDOLA Modena 41037 IT | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- FCGBiopsy Needle
- LODBone Cement
- PMLBone Cement, Posterior Screw Augmentation
- HXYBrace, Drill
- NDNCement, Bone, Vertebroplasty
- BYDCondenser, Heat And Moisture (Artificial Nose)
- MJGDevice, Percutaneous, Biopsy
- GDFGuide, Needle, Surgical
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- KNWInstrument, Biopsy
- JDZMixer, Cement, For Clinical Use
- GAANeedle, Aspiration And Injection, Disposable
- LXHOrthopedic Manual Surgical Instrument
- OCJSpinal Channeling Instrument, Vertebroplasty
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1649-2021 | 10 GAUGE DRILL, CODE INTVM-DRL | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1648-2021 | 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1647-2021 | 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15 | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1646-2021 | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1645-2021 | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1644-2021 | 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1643-2021 | 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1642-2021 | CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1641-2021 | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1640-2021 | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1639-2021 | 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1638-2021 | 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1637-2021 | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1636-2021 | EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1635-2021 | CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1634-2021 | BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111 | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1633-2021 | BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1632-2021 | RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated | |
| Z-1631-2021 | BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system | Products labeled as sterile were distributed, but may not have been sterilized. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain