Biotronik, Inc.
Biotronik, Inc. holds FDA 510(k) medical device clearances, first cleared 1994, most recent 2026, with 26 FDA device recalls on record.
Top product codes for Biotronik, Inc.
FDA recalls by Biotronik, Inc.
10 most recent of 26- Z-1459-2021 — BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Z-1449-2021 — BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Z-1465-2021 — BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Z-1442-2021 — BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Z-1448-2021 — BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Z-1457-2021 — BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Z-1445-2021 — BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Z-1456-2021 — BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Z-1443-2021 — BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Z-1444-2021 — BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
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 Biotronik, Inc.
- K261074 — BIOMONITOR IV (471155)
- K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter +5 more
- K242969 — Pantera Pro; Pantera LEO
- K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791) +2 more
- K241711 — Oscar Peripheral Multifunctional Catheter system
- K230375 — BIOMONITOR IV
- K222065 — Passeo-35 Xeo Peripheral Dilatation Catheter
- K221856 — BIOMONITOR IIIm, BIOMONITOR III
- K222037 — Selectra Lead Implantation System
- K214038 — Oscar Peripheral Multifunctional Catheter system
- K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter
- K201865 — Biomonitor III, Biomonitor IIIm
- K193474 — Selectra 3D Outer Guiding Catheters
- K200444 — Biomonitor III, Biomonitor IIIm
- K192996 — Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
- K191469 — Biotronik Stylets
- K190548 — BIOMONITOR III, Remote Assistant III
- K183265 — Selectra Catheters, Selectra Accessory Kit
- K171514 — BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
- K170628 — BioMonitor 2-AF, BioMonitor 2-S
- K163660 — Pantera LEO
- K160985 — Pantera Pro
- K152995 — BioMonitor 2-AF, BioMonitor 2-S
- K151744 — Passeo-18 Peripheral Dilation Catheter
- K152240 — Passeo-14 Peripheral Dilatation Catheter
- K151409 — Selectra Catheters and Selectra Accessory Kit
- K143503 — BioMonitor
- K142379 — Passeo-35 PTA Catheter
- K132960 — BIOMONITOR
- K131978 — SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
- K130161 — PASSEO-35
- K123324 — SELECTRA 7F CATHETERS
- K111839 — SELECTRA ACCESSORY KIT
- K112482 — SELECTRA SLITTER TOOL
- K111154 — SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
- K110461 — SELECTRA CS LEAD INTRODUCER SYSTEM
- K101776 — SCOUTPRO ACS
- K101282 — SCOUTPRO HEMOSTATIC VALVE
- K093303 — SCOUTPRO 7F LONG CATHETERS
- K083674 — PK-141 PATIENT CABLE
- K082935 — VISION WIRE CORONARY GUIDEWIRE
- K082933 — PASSEO-35 PTA CATHETER
- K080988 — SCOUTPRO CS LEAD INTRODUCER SYSTEM
- K072329 — SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
- K073230 — MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
- K072765 — PASSEO 18
- K071665 — SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
- K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS
- K060807 — SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
- K060655 — SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H
- K042373 — GALEO FOCUS GUIDE WIRE
- K042708 — ERA 3000 PACING SYSTEM ANALYZER
- K033613 — MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- K033320 — SCOUT PRO
- K033217 — PHERON PTA CATHETER
- K023205 — ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
- K022360 — ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.
- K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
- K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
- K020821 — SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
- K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP
- K010281 — MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
- K003454 — A1-CS-SB Y-ADAPTER, MODEL 124 871
- K003072 — PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
- K001736 — GALEO HYDRO AND GALEO HYDRO J-TIP
- K001413 — ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
- K994240 — EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
- K993139 — YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
- K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K991169 — SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
- K990483 — RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
- K982272 — GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018
- K980869 — SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
- K981083 — RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
- K972500 — TIR/TIJ AND POLYROX
- K965106 — ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
- K970388 — A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE
- K971930 — BK-N SEALING CAP
- K964190 — ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- K970204 — BK-A; BK-B; BK-IS SEALING CAP
- K964604 — BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
- K953044 — UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION
- K945627 — PIKOS LP 01, PIKOS LP E01
- K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
- K941937 — PIKOS E 01-B
Data sourced from openFDA. This site is unofficial and independent of the FDA.