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Biotronik, Inc.

Last updated September 17, 2026

Information

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

Catalogue (1129)

Page 22 of 23

Device	Model / Reference	Registries	Class	Status
Permanent Implantable Fh Endocardial Leads W/Tip	K910608	FDA 510(k)	Class III	Active
Selectra 7f Catheters	K123324	FDA 510(k)	Class II	Active
Passeo 18	K072765	FDA 510(k)	Class II	Active
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool	K192996	FDA 510(k)	Class II	Active
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set	K171514	FDA 510(k)	Class II	Active
Selectra Lead Implantation System	K222037	FDA 510(k)	Class II	Active
Biomonitor	K132960	FDA 510(k)	Class II	Active
Passeo-35 PTA Catheter	K142379	FDA 510(k)	Class II	Active
Px 53/15-Bp, Model 130 050 And Px 60/15-Bp, Model 130 051	K000763	FDA 510(k)	Class III	Active
Dnp 60-B Unipolar Endocardial Lead	K901709	FDA 510(k)	Class III	Active
Scoutpro 7f Long Catheters	K093303	FDA 510(k)	Class II	Active
BIOMONITOR IIIm, BIOMONITOR III	K221856	FDA 510(k)	Class II	Active
Bk-N Sealing Cap	K971930	FDA 510(k)	Class II	Active
Scout Pro	K033320	FDA 510(k)	Class II	Active
Modification To Biotronik's Sterilization Process	K023803	FDA 510(k)	Class III	Active
Permanent Implantable Jp Endocardial Leads W/Tip	K910609	FDA 510(k)	Class III	Active
Trios 02	K905087	FDA 510(k)	Class III	Active
Merox Bipolar High Impedance Lead Models: Mex 53/13-Bp; 60/15-Bp; 45-Jbp; 53-Jbp	K010281	FDA 510(k)	Class III	Active
Label Change Unipolar Endocardial Lead, Djp 60-Up	K903929	FDA 510(k)	Class III	Active
BioMonitor 2-AF, BioMonitor 2-S	K152995	FDA 510(k)	Class II	Active
Selectra Accessory Kit, Selectra Slitter Tool	K131978	FDA 510(k)	Class II	Active
Pikos 01-A And Pikos E01-A Implantable Pacemaker	K923026	FDA 510(k)	Class III	Active
Vision Wire Coronary Guidewire	K082935	FDA 510(k)	Class II	Active
Arox 45-Jbp; Arox 53-Jbp; Merox 45-Jbp; Merox 53-Jbp	K023099	FDA 510(k)	Class III	Active
Pk-141 Patient Cable	K083674	FDA 510(k)	Class II	Active
Galeo Hydro And Galeo Hydro J-Tip	K001736	FDA 510(k)	Class II	Active
Bioscope	K923406	FDA 510(k)	Class II	Active
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)	K240787	FDA 510(k)	Class II	Active
MultiCath, AcQRate Dx Fixed Curve Catheter	K201445	FDA 510(k)	Class II	Active
Bk-A; Bk-B; Bk-Is Sealing Cap	K970204	FDA 510(k)	Class II	Active
Nanos, Pikos 01/E01, 01-A, E01-B, Lp 01/Lp E01	K952328	FDA 510(k)	Class III	Active
BioMonitor	K143503	FDA 510(k)	Class II	Active
Neos (tm) 02 B Pulse Generator	K903081	FDA 510(k)	Class III	Active
Passeo-35	K130161	FDA 510(k)	Class II	Active
Labeling Changes To Pulse Gene. & Pulse Gene. Lead	K894494	FDA 510(k)	Class III	Active
Era 300 Dual Chamber Pacing System Analyzer	K964190	FDA 510(k)	Class II	Active
Modification To Era 300 Dual Chamber Pacing System Analyzer	K033613	FDA 510(k)	Class II	Active
Scout (sinus Cornarius Utility Tool), Model 335 117	K020821	FDA 510(k)	Class II	Active
Pikos E 01-B	K941937	FDA 510(k)	Class III	Active
Selectra 3D Outer Guiding Catheters	K193474	FDA 510(k)	Class II	Active
Arox 53-Bp; Arox 60-Bp; Arox 45-Jbp; Arox 53-Jbp	K021217	FDA 510(k)	Class III	Active
Elox 45-Bp, Model 330 132, Efh-27, Model 331 549, Extension Tool, Model 331 668	K001413	FDA 510(k)	Class III	Active
Oscar Peripheral Multifunctional Catheter system	K214038	FDA 510(k)	Class II	Active
Label Change Unipolar Endocardial Lead, Djp 45-Up	K903927	FDA 510(k)	Class III	Active
Galeo Focus Guide Wire	K042373	FDA 510(k)	Class II	Active
Ex 45-Bp, Model 330 132; Ex 53-Bp, Model 130 018; Ex 60-Bp, Model 330 133	K994240	FDA 510(k)	Class III	Active
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	K981083	FDA 510(k)	Class III	Active
Selectra Catheters, Selectra Accessory Kit	K183265	FDA 510(k)	Class II	Active
Passeo-35 Xeo Peripheral Dilatation Catheter	K222065	FDA 510(k)	Class II	Active
Elc 35-Up Model Number 116015 And Elc 54-Up Model Number 115606	K965106	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