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Biotronik, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 6024 JEAN RD., LAKE OSWEGO, OR, 97035
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1028232
DUNS Number: —

Catalogue (1129)

Page 21 of 23

Device	Model / Reference	Registries	Class	Status
Pulsar-18 T3	7/100/90	FDA UDI	Class III	Active
Orsiro Mission	4/26/140	FDA UDI	Class III	Active
Pulsar-18 T3	6/200/135	FDA UDI	Class III	Active
Pulsar-18 T3	4/150/90	FDA UDI	Class III	Active
Pulsar-18 T3	4/100/135	FDA UDI	Class III	Active
Orsiro Mission	3/13/140	FDA UDI	Class III	Active
Oscar PTA	4.0/20-180/80	FDA UDI	Class II	Active
PK Papyrus	2.5/20/140	FDA UDI	Unclassified	Active
Pulsar-18 T3	4/120/135	FDA UDI	Class III	Active
Cruiser-18	Stiff 300cm	FDA UDI	Class II	Active
Pulsar-18 T3	6/30/90	FDA UDI	Class III	Active
Oscar PTA	5.0/20-180/80	FDA UDI	Class II	Active
Pulsar-18 T3	4/150/135	FDA UDI	Class III	Active
Pulsar-18 T3	7/80/90	FDA UDI	Class III	Active
Orsiro Mission	2.75/26/140	FDA UDI	Class III	Active
Scoutpro 7f Coronary Sinus Lead Delivery System	K060807	FDA 510(k)	Class II	Active
Pantera LEO	K163660	FDA 510(k)	Class II	Active
Pantera Pro; Pantera LEO	K242969	FDA 510(k)	Class II	Active
A1-Cs-Sb Y-Adapter, Model 124 871	K003454	FDA 510(k)	Class II	Active
Scoutpro Cs Lead Introducer System	K080988	FDA 510(k)	Class II	Active
Synox Sx 53-Bp, Sx 60-Bp, Sx 45-Jbp, Sx 53-Jbp , Models 120 444, 119 684, 120 438 And 120 143	K980869	FDA 510(k)	Class III	Active
Oscar Peripheral Multifunctional Catheter system	K241711	FDA 510(k)	Class II	Active
A1-A, Abp, B, Mbp, Lead Connectors; Peh Adapter Sleeve	K970388	FDA 510(k)	Class II	Active
Pk-55 Andover Medical Part #5455 Label Change	K901332	FDA 510(k)	Class II	Active
Scoutpro 8f, 7f And Slitter Tool Advanced	K072329	FDA 510(k)	Class II	Active
Passeo-18 Peripheral Dilation Catheter	K151744	FDA 510(k)	Class II	Active
Label Change Unipolar Endocardial Lead Djp 53-Up	K903928	FDA 510(k)	Class III	Active
Retrox Rx 45-Jbp 124774, 53-Jbp 124775, 53-Bp 124776, 60-124777	K990483	FDA 510(k)	Class III	Active
Pantera Pro	K160985	FDA 510(k)	Class II	Active
Bipolar Implantable Endocardial Pacing Leads, With Silicone Rubber Insulation And Passive Fixation	K964604	FDA 510(k)	Class III	Active
Scoutpro 8f, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter, Models 342 263; Multi-Purpose H	K060655	FDA 510(k)	Class II	Active
Selectra Cs Lead Introducer System	K110461	FDA 510(k)	Class II	Active
Pheron Peripheral Percutaneous Transluminal Angioplasty (pta) Catheter	K052757	FDA 510(k)	Class II	Active
A1-A, A1-B, A1-Abp, A1-Mbp, A1-Z, A6-A, A6-B, Peh Pace.	K902889	FDA 510(k)	Class II	Active
Biomonitor III, Biomonitor IIIm	K201865	FDA 510(k)	Class II	Active
Selectra Catheters and Selectra Accessory Kit	K151409	FDA 510(k)	Class II	Active
Pheron Pta Catheter	K033217	FDA 510(k)	Class II	Active
Unipolar & Bioplar Implantable Endocardial Pacing Leads, With Silicone Rubber Insulation & Passive Fixation	K953044	FDA 510(k)	Class III	Active
BioMonitor 2-AF, BioMonitor 2-S	K170628	FDA 510(k)	Class II	Active
Biomonitor Iv	K230375	FDA 510(k)	Class II	Active
Scoutpro Slitter Tool Advanced, Model 356 552	K071665	FDA 510(k)	Class II	Active
Biotronik's Ps-Endocardial Leads	K896824	FDA 510(k)	Class III	Active
Biomonitor III, Biomonitor IIIm	K200444	FDA 510(k)	Class II	Active
Biotronik Stylets	K191469	FDA 510(k)	Class II	Active
Tir/Tij And Polyrox	K972500	FDA 510(k)	Class III	Active
Pacing Leads, Guide Wires, And Various Accessories	K003072	FDA 510(k)	Class III	Active
Models Era 300 And 3105 Pacing System Analyzers	K073230	FDA 510(k)	Class II	Active
Biotronik Endocardial Pacing Leads	K061212	FDA 510(k)	Class III	Active
Yp 45/15-Bp; Yp 53/15-Bp; Yp 60/15-Bp	K993139	FDA 510(k)	Class III	Active
Pikos Lp 01, Pikos Lp E01	K945627	FDA 510(k)	Class III	Active

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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