BIOTRONIK Inc

FDA Regulatory Profile

Summary

Total Recalls
26
510(k) Clearances
85
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1451-2021Class IIBIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provideMarch 8, 2021
Z-1441-2021Class IIBIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide March 8, 2021
Z-1449-2021Class IIBIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intendedMarch 8, 2021
Z-1442-2021Class IIBIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide March 8, 2021
Z-1448-2021Class IIBIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide vMarch 8, 2021
Z-1457-2021Class IIBIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to March 8, 2021
Z-1445-2021Class IIBIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provMarch 8, 2021
Z-1456-2021Class IIBIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to pMarch 8, 2021
Z-1459-2021Class IIBIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intendeMarch 8, 2021
Z-1443-2021Class IIBIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provideMarch 8, 2021
Z-1461-2021Class IIBIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to pMarch 8, 2021
Z-1460-2021Class IIBIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to prMarch 8, 2021
Z-1465-2021Class IIBIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intenMarch 8, 2021
Z-1458-2021Class IIBIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to pMarch 8, 2021
Z-1450-2021Class IIBIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provMarch 8, 2021
Z-1454-2021Class IIBIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended toMarch 8, 2021
Z-1446-2021Class IIBIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to March 8, 2021
Z-1462-2021Class IIBIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended tMarch 8, 2021
Z-1455-2021Class IIBIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to proMarch 8, 2021
Z-1447-2021Class IIBIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provMarch 8, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 PApril 4, 2025
K242969Pantera Pro; Pantera LEOOctober 25, 2024
K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); SelSeptember 12, 2024
K241711Oscar Peripheral Multifunctional Catheter systemJuly 11, 2024
K230375BIOMONITOR IVMay 19, 2023
K222065Passeo-35 Xeo Peripheral Dilatation CatheterFebruary 16, 2023
K221856BIOMONITOR IIIm, BIOMONITOR IIIJuly 27, 2022
K222037Selectra Lead Implantation SystemJuly 19, 2022
K214038Oscar Peripheral Multifunctional Catheter systemJuly 6, 2022
K201445MultiCath, AcQRate Dx Fixed Curve CatheterSeptember 2, 2021
K201865Biomonitor III, Biomonitor IIImDecember 8, 2020
K193474Selectra 3D Outer Guiding CathetersOctober 16, 2020
K200444Biomonitor III, Biomonitor IIImApril 23, 2020
K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolNovember 21, 2019
K191469Biotronik StyletsAugust 1, 2019
K190548BIOMONITOR III, Remote Assistant IIIJuly 5, 2019
K183265Selectra Catheters, Selectra Accessory KitDecember 13, 2018
K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetJune 29, 2017
K170628BioMonitor 2-AF, BioMonitor 2-SMarch 31, 2017
K163660Pantera LEOJanuary 26, 2017