BIOTRONIK AG
Lake Oswego, OR, US
BIOTRONIK AG appears in FDA device records in Lake Oswego, OR. FDA records list 104 510(k) clearances between and , 1,083 PMA records and 2 registered establishments. As of , FDA records show 42 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 104FDA records hold 104 510(k) clearances for BIOTRONIK AG between 1989 and 2026. The busiest year on record is 1990, with 8. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 8 |
| 1991 | 4 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 5 |
| 1998 | 4 |
| 1999 | 5 |
| 2000 | 4 |
| 2001 | 2 |
| 2002 | 5 |
| 2003 | 5 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 4 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 4 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 4 |
| 2016 | 2 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261074 | BIOMONITOR IV (471155) | MXD | Substantially Equivalent | |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | LIT | Substantially Equivalent | |
| K242969 | Pantera Pro; Pantera LEO | LOX | Substantially Equivalent | |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | DQY | Substantially Equivalent | |
| K241711 | Oscar Peripheral Multifunctional Catheter system | LIT | Substantially Equivalent | |
| K230375 | BIOMONITOR IV | MXD | Substantially Equivalent | |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | LIT | Substantially Equivalent | |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | MXD | Substantially Equivalent | |
| K222037 | Selectra Lead Implantation System | DQY | Substantially Equivalent | |
| K214038 | Oscar Peripheral Multifunctional Catheter system | LIT | Substantially Equivalent | |
| K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | DRF | Substantially Equivalent | |
| K201865 | Biomonitor III, Biomonitor IIIm | MXD | Substantially Equivalent | |
| K193474 | Selectra 3D Outer Guiding Catheters | DQY | Substantially Equivalent | |
| K200444 | Biomonitor III, Biomonitor IIIm | MXD | Substantially Equivalent | |
| K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | DQY | Substantially Equivalent | |
| K191469 | Biotronik Stylets | DRB | Substantially Equivalent | |
| K190548 | BIOMONITOR III, Remote Assistant III | MXD | Substantially Equivalent | |
| K183265 | Selectra Catheters, Selectra Accessory Kit | DQY | Substantially Equivalent | |
| K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set | MXD | Substantially Equivalent | |
| K170628 | BioMonitor 2-AF, BioMonitor 2-S | MXD | Substantially Equivalent | |
| K163660 | Pantera LEO | LOX | Substantially Equivalent | |
| K160985 | Pantera Pro | LOX | Substantially Equivalent | |
| K152995 | BioMonitor 2-AF, BioMonitor 2-S | MXD | Substantially Equivalent | |
| K152240 | Passeo-14 Peripheral Dilatation Catheter | LIT | Substantially Equivalent | |
| K151744 | Passeo-18 Peripheral Dilation Catheter | LIT | Substantially Equivalent | |
| K151409 | Selectra Catheters and Selectra Accessory Kit | DQY | Unknown | |
| K143503 | BioMonitor | MXD | Substantially Equivalent | |
| K142379 | Passeo-35 PTA Catheter | LIT | Substantially Equivalent | |
| K132960 | BIOMONITOR | MXD | Substantially Equivalent | |
| K131978 | SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL | DQY | Substantially Equivalent | |
| K130161 | PASSEO-35 | LIT | Substantially Equivalent | |
| K123324 | SELECTRA 7F CATHETERS | DQY | Substantially Equivalent | |
| K112482 | SELECTRA SLITTER TOOL | DQY | Substantially Equivalent | |
| K111839 | SELECTRA ACCESSORY KIT | DQY | Substantially Equivalent | |
| K111154 | SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 | DQY | Substantially Equivalent | |
| K110461 | SELECTRA CS LEAD INTRODUCER SYSTEM | DQY | Substantially Equivalent | |
| K101776 | SCOUTPRO ACS | DQY | Substantially Equivalent | |
| K101282 | SCOUTPRO HEMOSTATIC VALVE | DQY | Substantially Equivalent | |
| K093303 | SCOUTPRO 7F LONG CATHETERS | DQY | Substantially Equivalent | |
| K083674 | PK-141 PATIENT CABLE | DTC | Substantially Equivalent | |
| K082935 | VISION WIRE CORONARY GUIDEWIRE | DQX | Substantially Equivalent | |
| K082933 | PASSEO-35 PTA CATHETER | DQY | Substantially Equivalent | |
| K080988 | SCOUTPRO CS LEAD INTRODUCER SYSTEM | DQY | Substantially Equivalent | |
| K072329 | SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED | DQY | Substantially Equivalent | |
| K073230 | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | DTA | Substantially Equivalent | |
| K072765 | PASSEO 18 | LIT | Substantially Equivalent | |
| K071665 | SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 | DQY | Substantially Equivalent | |
| K061212 | BIOTRONIK ENDOCARDIAL PACING LEADS | DTB | Substantially Equivalent | |
| K060807 | SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM | DQY | Substantially Equivalent | |
| K060655 | SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043892 | 3002808050 | BIOTRONIK AG | ACKERSTRASSE 6, BULACH Zurich CH-8180 CH | 2026 | and 1 more, listed in full below |
| 1028232 | 1028232 | BIOTRONIK, INC. | 6024 JEAN RD., LAKE OSWEGO, OR 97035 US | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTCAnalyzer, Pacemaker Generator Function
- KREAnalyzer, Pacemaker Generator Function, Indirect
- LITCatheter, Angioplasty, Peripheral, Transluminal
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DQYCatheter, Percutaneous
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous
- NIVCoronary Covered Stent
- NIQCoronary Drug-Eluting Stent
- NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- MRMDefibrillator, Implantable, Dual-Chamber
- DREDilator, Vessel, For Percutaneous Catheterization
- OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
- NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- DPSElectrocardiograph
- LWSImplantable Cardioverter Defibrillator (Non-Crt)
- DXYImplantable Pacemaker Pulse-Generator
- LWPImplantable Pulse Generator, Pacemaker (Non-Crt)
- DYBIntroducer, Catheter
- DTDPacemaker Lead Adaptor
- OSRPacemaker/Icd/Crt Non-Implanted Components
- NVYPermanent Defibrillator Electrodes
- DTBPermanent Pacemaker Electrode
- KRGProgrammer, Pacemaker
- OVJPulse Generator, External Pacemaker, Dual Chamber
- NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- NVZPulse Generator, Permanent, Implantable
- DTEPulse-Generator, Pacemaker, External
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- MAFStent, Coronary
- NIOStent, Iliac
- NIPStent, Superficial Femoral Artery
- DRBStylet, Catheter
- DTATester, Pacemaker Electrode Function
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 42| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1464-2021 | BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1463-2021 | BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1462-2021 | BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1461-2021 | BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1460-2021 | BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1458-2021 | BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1455-2021 | BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1454-2021 | BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1453-2021 | BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1452-2021 | BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1451-2021 | BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1450-2021 | BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1447-2021 | BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1446-2021 | BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| 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. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated | |
| Z-1441-2021 | BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain