BIOPSYBELL S.R.L.

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
7
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1636-2021Class IIEASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DSMarch 22, 2021
Z-1639-2021Class II10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAKMarch 22, 2021
Z-1631-2021Class IIBPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing systemMarch 22, 2021
Z-1632-2021Class IIRENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-USMarch 22, 2021
Z-1645-2021Class II8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCBMarch 22, 2021
Z-1634-2021Class IIBPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111March 22, 2021
Z-1643-2021Class II11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCDMarch 22, 2021
Z-1635-2021Class IICEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051March 22, 2021
Z-1633-2021Class IIBPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-USMarch 22, 2021
Z-1648-2021Class II10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CCMarch 22, 2021
Z-1638-2021Class II10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDCMarch 22, 2021
Z-1647-2021Class II10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15March 22, 2021
Z-1640-2021Class II8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCBMarch 22, 2021
Z-1642-2021Class IICEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMSMarch 22, 2021
Z-1649-2021Class II10 GAUGE DRILL, CODE INTVM-DRLMarch 22, 2021
Z-1646-2021Class II10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDKMarch 22, 2021
Z-1644-2021Class II11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAKMarch 22, 2021
Z-1641-2021Class II11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDKMarch 22, 2021
Z-1637-2021Class II10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBDMarch 22, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K231340Renova Spine Balloon CatheterOctober 30, 2023
K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, January 11, 2021
K180315DISKOMMarch 26, 2018
K130616MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLESFebruary 7, 2014
K010735SPEEDYBELLAugust 17, 2001
K011075EASYBELLJune 27, 2001
K011104OSTEOBELLMay 31, 2001