Company ยท US
Biotronik, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2026. Name variants (Inc, Corp, punctuation) are merged.
104510(k) clearances (1 in 12 months)
42recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTB | Permanent Pacemaker Electrode | 26 |
| DQY | Catheter, Percutaneous | 23 |
| MRM | Defibrillator, Implantable, Dual-Chamber | 22 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 19 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 11 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 10 |
| DXY | Implantable Pacemaker Pulse-Generator | 9 |
| DTD | Pacemaker Lead Adaptor | 6 |
| DQX | Wire, Guide, Catheter | 5 |
| DTA | Tester, Pacemaker Electrode Function | 3 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 3 |
| DTC | Analyzer, Pacemaker Generator Function | 2 |
| DTE | Pulse-Generator, Pacemaker, External | 2 |
| DPS | Electrocardiograph | 1 |
| DRB | Stylet, Catheter | 1 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 |
| KRE | Analyzer, Pacemaker Generator Function, Indirect | 1 |
| RCE | Cabinet X-Ray, Industrial | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2026 | K261074 | BIOMONITOR IV (471155) Biotronik, Inc. | MXD |
| Apr 4, 2025 | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Biotronik, Inc. | LIT |
| Oct 25, 2024 | K242969 | Pantera Pro; Pantera LEO Biotronik, Inc. | LOX |
| Sep 12, 2024 | K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit Biotronik, Inc. | DQY |
| Jul 11, 2024 | K241711 | Oscar Peripheral Multifunctional Catheter system Biotronik, Inc. | LIT |
| May 19, 2023 | K230375 | BIOMONITOR IV Biotronik, Inc. | MXD |
| Feb 16, 2023 | K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter Biotronik, Inc. | LIT |
| Jul 27, 2022 | K221856 | BIOMONITOR IIIm, BIOMONITOR III Biotronik, Inc. | MXD |
| Jul 19, 2022 | K222037 | Selectra Lead Implantation System Biotronik, Inc. | DQY |
| Jul 6, 2022 | K214038 | Oscar Peripheral Multifunctional Catheter system Biotronik, Inc. | LIT |
| Sep 2, 2021 | K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter Biotronik, Inc. | DRF |
| Dec 8, 2020 | K201865 | Biomonitor III, Biomonitor IIIm Biotronik, Inc. | MXD |
| Oct 16, 2020 | K193474 | Selectra 3D Outer Guiding Catheters Biotronik, Inc. | DQY |
| Apr 23, 2020 | K200444 | Biomonitor III, Biomonitor IIIm Biotronik, Inc. | MXD |
| Nov 21, 2019 | K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool Biotronik, Inc. | DQY |
| Aug 1, 2019 | K191469 | Biotronik Stylets Biotronik, Inc. | DRB |
| Jul 5, 2019 | K190548 | BIOMONITOR III, Remote Assistant III Biotronik, Inc. | MXD |
| Dec 13, 2018 | K183265 | Selectra Catheters, Selectra Accessory Kit Biotronik, Inc. | DQY |
| Jun 29, 2017 | K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set Biotronik, Inc. | MXD |
| Mar 31, 2017 | K170628 | BioMonitor 2-AF, BioMonitor 2-S Biotronik, Inc. | MXD |
| Jan 26, 2017 | K163660 | Pantera LEO Biotronik, Inc. | LOX |
| Oct 7, 2016 | K160985 | Pantera Pro Biotronik, Inc. | LOX |
| Apr 11, 2016 | K152995 | BioMonitor 2-AF, BioMonitor 2-S Biotronik, Inc. | MXD |
| Oct 8, 2015 | K152240 | Passeo-14 Peripheral Dilatation Catheter Biotronik, Inc. | LIT |
| Oct 8, 2015 | K151744 | Passeo-18 Peripheral Dilation Catheter Biotronik, Inc. | LIT |
| Aug 7, 2015 | K151409 | Selectra Catheters and Selectra Accessory Kit Biotronik, Inc. | DQY |
| Mar 19, 2015 | K143503 | BioMonitor Biotronik, Inc. | MXD |
| Dec 5, 2014 | K142379 | Passeo-35 PTA Catheter Biotronik, Inc. | LIT |
| Jun 6, 2014 | K132960 | BIOMONITOR Biotronik, Inc. | MXD |
| Aug 23, 2013 | K131978 | SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL Biotronik, Inc. | DQY |
| Apr 23, 2013 | K130161 | PASSEO-35 Biotronik, Inc. | LIT |
| Jan 11, 2013 | K123324 | SELECTRA 7F CATHETERS Biotronik, Inc. | DQY |
| Sep 26, 2011 | K112482 | SELECTRA SLITTER TOOL Biotronik, Inc. | DQY |
| Sep 26, 2011 | K111839 | SELECTRA ACCESSORY KIT Biotronik, Inc. | DQY |
| May 23, 2011 | K111154 | SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 Biotronik, Inc. | DQY |
| Apr 20, 2011 | K110461 | SELECTRA CS LEAD INTRODUCER SYSTEM Biotronik, Inc. | DQY |
| Jul 23, 2010 | K101776 | SCOUTPRO ACS Biotronik, Inc. | DQY |
| Jul 21, 2010 | K101282 | SCOUTPRO HEMOSTATIC VALVE Biotronik, Inc. | DQY |
| Nov 20, 2009 | K093303 | SCOUTPRO 7F LONG CATHETERS Biotronik, Inc. | DQY |
| Apr 1, 2009 | K083674 | PK-141 PATIENT CABLE Biotronik, Inc. | DTC |
| Dec 4, 2008 | K082935 | VISION WIRE CORONARY GUIDEWIRE Biotronik, Inc. | DQX |
| Nov 3, 2008 | K082933 | PASSEO-35 PTA CATHETER Biotronik, Inc. | DQY |
| May 7, 2008 | K080988 | SCOUTPRO CS LEAD INTRODUCER SYSTEM Biotronik, Inc. | DQY |
| Mar 25, 2008 | K072329 | SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED Biotronik, Inc. | DQY |
| Dec 20, 2007 | K073230 | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS Biotronik, Inc. | DTA |
| Dec 12, 2007 | K072765 | PASSEO 18 Biotronik, Inc. | LIT |
| Jul 18, 2007 | K071665 | SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 Biotronik, Inc. | DQY |
| Jul 10, 2006 | K061212 | BIOTRONIK ENDOCARDIAL PACING LEADS Biotronik, Inc. | DTB |
| Apr 24, 2006 | K060807 | SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM Biotronik, Inc. | DQY |
| Apr 4, 2006 | K060655 | SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H Biotronik, Inc. | DQY |
Newest 50 of 104.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2021 | BIOTRONIK Inc 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 Terminated |
LWS | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 l Terminated |
LWS | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 o Terminated |
LWS | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 l Terminated |
LWS | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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- Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 o Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 lif Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-t Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 li Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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- Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-threa Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-threa Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-th Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-threate Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-th Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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 lif Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-th Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-threa Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-threa Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-threat Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc 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-threat Terminated |
MRM | None listed |
| Aug 13, 2015 | BIOTRONIK, Inc. PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000).
Allow Terminated |
RCE | None listed |
| Jul 29, 2008 | Biotronik Inc Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; I Terminated |
MRM | None listed |
| Jul 20, 2004 | Biotronik Inc Deikos A+ Terminated |
LWS | None listed |
| Jul 20, 2004 | Biotronik Inc Tachos ATx Terminated |
LWS | None listed |
| Jul 20, 2004 | Biotronik Inc Tachos DR - Atrial Tx Terminated |
LWS | None listed |
| Jul 20, 2004 | Biotronik Inc Tachos DR - Implantable Cardioverter Defibrillator Terminated |
LWS | None listed |
| Oct 31, 2003 | Biotronik Inc Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Terminated |
LWS | None listed |
| Oct 31, 2003 | Biotronik Inc Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Terminated |
LWS | None listed |
| Oct 31, 2003 | Biotronik Inc Belos VR-T Implantable Cardioverter Defibrillator Terminated |
LWS | None listed |
| Oct 31, 2003 | Biotronik Inc Belos VR Implantable Cardioverter Defibrillator Terminated |
LWS | None listed |
| Oct 31, 2003 | Biotronik Inc Belos DR-T Implantable Cardioverter Defibrillator Terminated |
LWS | None listed |
| Oct 31, 2003 | Biotronik Inc Belos DR Implantable Cardioverter Defibrillator Terminated |
LWS | None listed |
| May 14, 2003 | Biotronik Inc Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator.
The Belos VR-T is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ven Terminated |
LWS | None listed |
| May 14, 2003 | Biotronik Inc Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats vent Terminated |
LWS | None listed |
| Apr 1, 2003 | Biotronik Inc Tachos DR - Atrial TX Implantable Cardioverter Defibrillators Terminated |
LWS | None listed |
| Apr 1, 2003 | Biotronik Inc Deikos A+ Implantable Cardioverter Defibrillator Terminated |
LWS | None listed |
| Apr 1, 2003 | Biotronik Inc Tachos DR - Implantable Cardioverter Defibrillator. Terminated |
LWS | None listed |