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BIOTRONIK, Inc.

17 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer soft recall (Z-2376-2015)BIOTRONIK, Inc.2015-08-13
Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber de recall (Z-1373-2008)Biotronik Inc2008-07-29
Tachos DR - Implantable Cardioverter Defibrillator recall (Z-0941-04)Biotronik Inc2004-07-20
Tachos DR - Atrial Tx recall (Z-0942-04)Biotronik Inc2004-07-20
Tachos ATx recall (Z-0943-04)Biotronik Inc2004-07-20
Deikos A+ recall (Z-0944-04)Biotronik Inc2004-07-20
Belos DR Implantable Cardioverter Defibrillator recall (Z-0072-04)Biotronik Inc2003-10-31
Belos DR-T Implantable Cardioverter Defibrillator recall (Z-0073-04)Biotronik Inc2003-10-31
Belos VR Implantable Cardioverter Defibrillator recall (Z-0074-04)Biotronik Inc2003-10-31
Belos VR-T Implantable Cardioverter Defibrillator recall (Z-0075-04)Biotronik Inc2003-10-31
Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer recall (Z-0076-04)Biotronik Inc2003-10-31
Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programme recall (Z-0077-04)Biotronik Inc2003-10-31
Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators recall (Z-0816-03)Biotronik Inc2003-05-14
Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. recall (Z-0817-03)Biotronik Inc2003-05-14
Tachos DR - Implantable Cardioverter Defibrillator. recall (Z-0700-03)Biotronik Inc2003-04-01
Deikos A+ Implantable Cardioverter Defibrillator recall (Z-0701-03)Biotronik Inc2003-04-01
Tachos DR - Atrial TX Implantable Cardioverter Defibrillators recall (Z-0702-03)Biotronik Inc2003-04-01

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Every clearance here is in the API, with alerts when new ones post.