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Data / Medical devices / Germany / Biotronik Se & Co. KG

Biotronik Se & Co. KG: FDA-registered device maker in Berlin, Germany, 24 510(k) clearances and 7 PMA approvals

Biotronik Se & Co. KG is registered with the FDA (registration 9610139) in Berlin, Germany. It lists 26 device types. The FDA files 24 510(k) clearances and 7 PMA approvals under its listings, the newest dated September 12, 2024. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Biotronik Se & Co. KG
FDA registration number
9610139
FEI number
3002806500
Address
Woermannkehre 1, Berlin, Germany, D-12359
Owner or operator
BIOTRONIK SE & CO. KG (9018331)
Roles
Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 31, 2007
Registered through
2027
Brand names listed
A1-CS-SB, Acticor Sky, Acticor family, BIOMONITOR III, BIOMONITOR IIIm, BIOMONITOR IV, BIOTRONIK test magnet, BIOexpress and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Pacemaker Generator FunctionDTC2Manufactureraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufactureraccessdata.fda.gov
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK3Manufactureraccessdata.fda.gov
Defibrillator, Implantable, Dual-ChamberMRM3Manufactureraccessdata.fda.gov
Dilator, Vessel, For Percutaneous CatheterizationDRE2Manufactureraccessdata.fda.gov
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX3Manufactureraccessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN3Manufactureraccessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)LWS3Manufactureraccessdata.fda.gov
Implantable Pacemaker Pulse-GeneratorDXY3Manufactureraccessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)LWP3Manufactureraccessdata.fda.gov
Magnet, Test, PacemakerDTG1Specification developeraccessdata.fda.gov
Pacemaker Lead AdaptorDTD2Manufactureraccessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted ComponentsOSR3Manufactureraccessdata.fda.gov
Permanent Defibrillator ElectrodesNVY3Manufactureraccessdata.fda.gov
Permanent Pacemaker ElectrodeDTB3Manufactureraccessdata.fda.gov
Programmer, PacemakerKRG3Manufactureraccessdata.fda.gov
Pulse Generator, External Pacemaker, Dual ChamberOVJ2Manufactureraccessdata.fda.gov
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE3Manufactureraccessdata.fda.gov
Pulse Generator, Permanent, ImplantableNVZ3Manufactureraccessdata.fda.gov
Pulse-Generator, Pacemaker, ExternalDTE2Manufactureraccessdata.fda.gov
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)MXD2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW3Manufactureraccessdata.fda.gov
Stylet, CatheterDRB2Manufactureraccessdata.fda.gov
Tester, Pacemaker Electrode FunctionDTA2Manufactureraccessdata.fda.gov
Wire, Guide, CatheterDQX2Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 12, 2024K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)DQYSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
May 19, 2023K230375BIOMONITOR IVMXDSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
July 27, 2022K221856BIOMONITOR IIIm, BIOMONITOR IIIMXDSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
July 19, 2022K222037Selectra Lead Implantation SystemDQYSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
October 15, 2021K212593ViaCath, AcQRate Dx Steerable CatheterDRFSubstantially EquivalentBiotronick, Inc.accessdata.fda.gov
September 2, 2021K201445MultiCath, AcQRate Dx Fixed Curve CatheterDRFSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
October 16, 2020K193474Selectra 3D Outer Guiding CathetersDQYSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
April 23, 2020K200444Biomonitor III, Biomonitor IIImMXDSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
November 21, 2019K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolDQYSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
August 1, 2019K191469Biotronik StyletsDRBSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
July 5, 2019K190548BIOMONITOR III, Remote Assistant IIIMXDSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
April 11, 2016K152995BioMonitor 2-AF, BioMonitor 2-SMXDSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
August 7, 2015K151409Selectra Catheters and Selectra Accessory KitDQYUnknownBiotronik, Inc.accessdata.fda.gov
March 19, 2015K143503BioMonitorMXDSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
September 26, 2011K112482SELECTRA SLITTER TOOLDQYSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
September 26, 2011K111839SELECTRA ACCESSORY KITDQYSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
May 23, 2011K111154SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75DQYSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
April 20, 2011K110461SELECTRA CS LEAD INTRODUCER SYSTEMDQYSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
April 1, 2009K083674PK-141 PATIENT CABLEDTCSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
December 4, 2008K082935VISION WIRE CORONARY GUIDEWIREDQXSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
January 18, 2001K003454A1-CS-SB Y-ADAPTER, MODEL 124 871DTDSubstantially Equivalent - Subject to Tracking Reg.Biotronik, Inc.accessdata.fda.gov
August 14, 1997K971930BK-N SEALING CAPDTDSubstantially Equivalent - Subject to Tracking & PMSBiotronik, Inc.accessdata.fda.gov
July 10, 1997K964190ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERDTESubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
April 29, 1997K970204BK-A; BK-B; BK-IS SEALING CAPDTDSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
March 31, 2023P210037Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote ManagementLGW14June 5, 2026accessdata.fda.gov
May 12, 2008P070008STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADNKE177October 22, 2026accessdata.fda.gov
August 10, 2006P050023TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEADMRM209October 22, 2026accessdata.fda.gov
September 29, 2000P000009PHYLAX AV ICD SYSTEMMRM128October 22, 2026accessdata.fda.gov
October 27, 1998P980023PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMLWS150October 22, 2026accessdata.fda.gov
October 11, 1996P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSDXY282October 22, 2026accessdata.fda.gov
February 15, 1984P820076DIPLOS MODEL 05 A & BLWP28February 12, 2019accessdata.fda.gov

Compare with other makers

Updated June 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.