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Sign in to claim this brandBiotronik, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 6024 JEAN RD., LAKE OSWEGO, OR, 97035
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1028232
- DUNS Number
- —
Catalogue (1129)
Page 1 of 23| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Selectra Accessory Kit | K111839 | FDA 510(k) | Class II | Active |
| Passeo-35 Xeo | 10/20/170 | FDA UDI | Class II | Active |
| Passeo-35 | 5/60/80 | FDA UDI | Class II | Unknown |
| Orsiro Mission | 2.25/30/140 | FDA UDI | Class III | Active |
| Pantera LEO | 2.25/20/145 | FDA UDI | Class II | Active |
| Passeo-18 | 3/60/90 | FDA UDI | Class II | Active |
| Astron | 7/80/72 | FDA UDI | Class III | Active |
| Oscar | 3.5/20-180/127 | EUDAMEDFDA UDI | Class II | Active |
| Pulsar-18 | 5/60/90 | FDA UDI | Class III | Active |
| PK Papyrus | 3.0/26/140 | FDA UDI | Unclassified | Active |
| Passeo-35 Xeo | 5/40/130 | FDA UDI | Class II | Active |
| Orsiro | 3.5/13/140 | FDA UDI | Class III | Unknown |
| Orsiro Mission | 2.75/9/140 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 3/100/90 | FDA UDI | Class II | Active |
| Passeo-35 Xeo | 9/120/130 | FDA UDI | Class II | Active |
| Passeo-35 Xeo | 5/200/170 | FDA UDI | Class II | Active |
| Orsiro | 4.0/15/140 | FDA UDI | Class III | Unknown |
| Pulsar-18 T3 | 5/40/135 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 9/60/170 | FDA UDI | Class II | Active |
| Passeo-18 | 2.5/60/130 | FDA UDI | Class II | Active |
| Pantera LEO | 2.5/8/145 | FDA UDI | Class II | Active |
| Pulsar-18 | 6/200/135 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 7/100/90 | FDA UDI | Class II | Active |
| Orsiro | 3.5/40/140 | FDA UDI | Class III | Unknown |
| Pulsar-18 T3 | 5/120/90 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 5/40/170 | FDA UDI | Class II | Active |
| Passeo-35 | 6/170/90 | FDA UDI | Class II | Unknown |
| Pulsar-18 | 5/150/90 | FDA UDI | Class III | Active |
| Passeo-14 | 1.5/70/120 | FDA UDI | Class II | Active |
| Passeo-18 | 5/20/130 | FDA UDI | Class II | Active |
| Passeo-18 | 2/170/90 | FDA UDI | Class II | Active |
| Passeo-14 | 4/40/90 | FDA UDI | Class II | Active |
| Passeo-18 | 2.5/200/130 | FDA UDI | Class II | Active |
| Passeo-18 | 5/170/130 | FDA UDI | Class II | Active |
| Passeo-35 Xeo | 6/120/170 | FDA UDI | Class II | Active |
| Orsiro | 2.5/30/140 | FDA UDI | Class III | Unknown |
| Pulsar-18 | 5/100/135 | FDA UDI | Class III | Active |
| Passeo-35 Xeo | 8/20/90 | FDA UDI | Class II | Active |
| Pantera LEO | 2.0/8/145 | FDA UDI | Class II | Active |
| Passeo-14 | 4/140/90 | FDA UDI | Class II | Active |
| Pantera LEO | 3.25/8/145 | FDA UDI | Class II | Active |
| Passeo-35 | 10/20/80 | FDA UDI | Class II | Unknown |
| Passeo-35 Xeo | 12/40/90 | FDA UDI | Class II | Active |
| Passeo-18 | 4/150/90 | FDA UDI | Class II | Active |
| Passeo-35 | 8/40/130 | FDA UDI | Class II | Unknown |
| Pantera Pro | 3.00/10/140 | FDA UDI | Class II | Active |
| Passeo-18 | 3/80/90 | FDA UDI | Class II | Active |
| Passeo-14 | 4/70/150 | FDA UDI | Class II | Active |
| Passeo-14 | 3.5/100/150 | FDA UDI | Class II | Active |
| PRO-Kinetic Energy | 2.25/9/140 | FDA UDI | Class III | Active |
Related Companies
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Authorities
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FDA Recalls (42)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 8, 2021 | Z-1460-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1454-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1453-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1464-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1448-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1463-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1451-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1457-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1456-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1465-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1458-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1459-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1446-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1461-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1449-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1441-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1455-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1462-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1450-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1443-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1452-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1442-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1447-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1445-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Mar 8, 2021 | Z-1444-2021 | — | terminated | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) |
| Jun 30, 2015 | Z-2376-2015 | — | terminated | Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US. |
| Jan 10, 2007 | Z-1373-2008 | — | terminated | Timing Feature Error: An implementation error allows the usage of the V-V timing feature, which is not approved for use in the U.S. |
| Apr 29, 2004 | Z-0944-04 | — | terminated | Potential for device to not deliver full amount of energy |
| Apr 29, 2004 | Z-0943-04 | — | terminated | Potential for device to not deliver full amount of energy |
| Apr 29, 2004 | Z-0941-04 | — | terminated | Potential for device to not deliver full amount of energy |
| Apr 29, 2004 | Z-0942-04 | — | terminated | Potential for device to not deliver full amount of energy |
| Sep 24, 2003 | Z-0075-04 | — | terminated | Potential extended charge time anomalies. |
| Sep 24, 2003 | Z-0073-04 | — | terminated | Potential extended charge time anomalies. |
| Sep 24, 2003 | Z-0074-04 | — | terminated | Potential extended charge time anomalies. |
| Sep 24, 2003 | Z-0076-04 | — | terminated | Potential for early depletion of Implantable Cardioverter Defibrillator battery. |
| Sep 24, 2003 | Z-0077-04 | — | terminated | Potential for early depletion of Implantable Cardioverter Defibrillator battery. |
| Sep 24, 2003 | Z-0072-04 | — | terminated | Potential extended charge time anomalies. |
| Mar 21, 2003 | Z-0817-03 | — | terminated | Potential extended charge time anomalies |
| Mar 21, 2003 | Z-0816-03 | — | terminated | Potential extended charge time anomalies |
| Feb 21, 2003 | Z-0700-03 | — | terminated | Potential for battery to delivery less than full amount of energy. |
| Feb 21, 2003 | Z-0702-03 | — | terminated | Potential for battery to delivery less than full amount of energy |
| Feb 21, 2003 | Z-0701-03 | — | terminated | Potential for battery to delivery less than full amount of energy |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Biotronik Ag BULACH Zurich · CH FEI 3002808050