Is this your brand? Sign in to claim ownership.

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 23 of 23

Device	Model / Reference	Registries	Class	Status
Galeo Hs 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo F 014 Model 115 487 Galeo Hf 018	K982272	FDA 510(k)	Class II	Active
Scoutpro Hemostatic Valve	K101282	FDA 510(k)	Class II	Active
Elox P 45-Bp; Elox P 53-Bp; Elox P 60-Bp	K023205	FDA 510(k)	Class III	Active
Era 3000; Pa-2 Is-1 Adapter; Ek-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (type 2); Nk-11 Power Supp.	K022360	FDA 510(k)	Class II	Active
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	K250706	FDA 510(k)	Class II	Active
Passeo-14 Peripheral Dilatation Catheter	K152240	FDA 510(k)	Class II	Active
Sx 53/15-Bp, Model 124 853, Sx 60/15-Bp, Model 124 854	K991169	FDA 510(k)	Class III	Active
Biomonitor Iv (471155)	K261074	FDA 510(k)	Class II	Active
Scoutpro Acs	K101776	FDA 510(k)	Class II	Active
Hpm 40 Heart Pacemaker Monitor	K922742	FDA 510(k)	Class II	Active
Pikos 01 & Pikos E 01	K914109	FDA 510(k)	Class III	Active
Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-A, Pikos E01-A	K993434	FDA 510(k)	Class III	Active
Lead Terminal Pin Caps, Various Models	K911142	FDA 510(k)	Class II	Active
BIOMONITOR III, Remote Assistant III	K190548	FDA 510(k)	Class II	Active
Era 3000 Pacing System Analyzer	K042708	FDA 510(k)	Class II	Active
Selectra Ic-50-60, Selectra Ic-50-75, Selectra Ic-90-65, Selectra Ic-90-75	K111154	FDA 510(k)	Class II	Active
Passeo-35 Pta Catheter	K082933	FDA 510(k)	Class II	Active
Rithron-Xr Coronary Stent System	P030037	FDA PMA	Class III	Active
Astron Stent System	P140030	FDA PMA	Class III	Active
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Class III; Prospera SCS System	P210037	FDA PMA	Class III	Active
Intica Neo 5 DR-T DF-1 ProMRI, Ilivia Neo 7 DR-T DF-1 ProMRI, Intica Neo 7 DR-T DF-1 ProMRI	P000009	FDA PMA	Class III	Active
Efh-16; S 60-K; S 60-J; S 60-S	P820076	FDA PMA	Class III	Active
Astron Pulsar Stent System and Pulsar-18 Stent System	P160025	FDA PMA	Class III	Active
Linox(smart) S & Linox(smart) T Steroid-Eluting Dual-Coil Icd Leads	P980023	FDA PMA	Class III	Active
Stratos, Evia, & Entovis Families Of Crt-P's	P070008	FDA PMA	Class III	Active
PRO-Kinetic Energy Coronary Stent System	P160003	FDA PMA	Class III	Active
Orsiro Sirolimus Eluting Coronary Stent System	P170030	FDA PMA	Class III	Active
Psw 1704.u	P050023	FDA PMA	Class III	Active
Home Monitoring System Version 3.48	P950037	FDA PMA	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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