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Biotronik, Inc.

945 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
PHILOS, CYLOS, EVIA, ESTELLA, EFFECTA FAMILY IMPLANTABLE PULSE GENERATORS (P950037/S107)Biotronik, Inc.2012-12-03
EVIA PACEMAKER FAMILY (P950037/S112)Biotronik, Inc.2012-10-10
LINOX LEAD FAMILY (P980023/S048)Biotronik, Inc.2012-10-10
LUMAX ICD FAMILY (P050023/S055)Biotronik, Inc.2012-10-10
COROX LEAD FAMILY (P070008/S034)Biotronik, Inc.2012-10-10
STRATOS LV/LV-T (P070008/S031)Biotronik, Inc.2012-10-03
BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S049)Biotronik, Inc.2012-10-03
VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS (P950037/S105)Biotronik, Inc.2012-10-03
KRONOS LV-T CRT-D AND LUMAX 300/340 & 500/540 CRT-D'S & ICD'S (P050023/S053)Biotronik, Inc.2012-10-03
LINOX SMART (P980023/S047)Biotronik, Inc.2012-09-24
REOCOR S/D EXTERNAL PACEMAKER (P950037/S111)Biotronik, Inc.2012-09-24
RELIATY / MODEL 3145 PACING SYSTEM (P950037/S109)Biotronik, Inc.2012-08-28
VARIOUS FAMILIES OF ACTROS, AXIOS, 8A03, CYLOS, DROMOS, KAIROS, PHILOS, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, & ESTELLA (P950037/S110)Biotronik, Inc.2012-08-08
BELOS AND LEXOS DR/DR-T/VR-T, LUMOS DR/VR-T, XELOS DR-T ICD'S (P000009/S050)Biotronik, Inc.2012-08-08
KRONOS LV-T & VARIOUS FAMILIES OF LUMAX HF CRT-D's; VARIOUS FAMILIES OF LUMAX DR & VR ICD's (P050023/S054)Biotronik, Inc.2012-08-08
STRATOS LV/LV-T CRT-P (P070008/S033)Biotronik, Inc.2012-08-08
DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM (P950037/S108)Biotronik, Inc.2012-05-17
REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS (P950037/S084)Biotronik, Inc.2012-05-08
BELOS DR/DR-T/VR/VR-T/LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T (P000009/S047)Biotronik, Inc.2012-05-04
LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T (P050023/S048)Biotronik, Inc.2012-05-04
CYLOS/DR/DR-T/VR/DROMOS DR/SR/SL/KAIROS DR/SR/SL/D/S/PHILOS/DR/DR-T/SR/SLR/D/S/PHILOS II D/DR/S/SLR/SR/DR-T/PROTOS DR/CL (P950037/S100)Biotronik, Inc.2012-05-04
STRATOS LV/LV-T (P070008/S028)Biotronik, Inc.2012-05-04
CARDIO MESSENGER II & CARDIO MESSENGER II-S FAMILIES (P950037/S102)Biotronik, Inc.2012-03-29
CARDIO MESSENGER & CARDIO MESSENGER II-S FAMILIES (P050023/S049)Biotronik, Inc.2012-03-29
LUMAX ICDS AND CRT-DS (P050023/S050)Biotronik, Inc.2012-03-29
EVIA / ENTOVIS FAMILY PULSE GENERATORS (P950037/S101)Biotronik, Inc.2012-03-23
STRATOS LV/LV-T (P070008/S030)Biotronik, Inc.2012-03-15
VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS (P950037/S104)Biotronik, Inc.2012-03-15
BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S048)Biotronik, Inc.2012-03-15
KRONOS LV-T CRT-D AND LUMAX 300/340 & 500/540 CRT-D'S & ICD'S (P050023/S052)Biotronik, Inc.2012-03-15
STRATOS LV/LV-T (P070008/S029)Biotronik, Inc.2012-03-05
LUMAX ICDS AND CRT-DS (P050023/S051)Biotronik, Inc.2012-03-05
VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS (P950037/S103)Biotronik, Inc.2012-03-05
ICS 3000 IMPLANT MODULE AUTOMATED TEST (P820076/S025)Biotronik, Inc.2012-02-24
STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP (P070008/S024)Biotronik, Inc.2012-02-24
EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S097)Biotronik, Inc.2012-02-24
VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS (P980023/S046)Biotronik, Inc.2012-02-22
VARIOUS FAMILIES/MODELS OF TILDA BRADYCARDIA PACING LEADS (P950037/S099)Biotronik, Inc.2011-12-02
VARIOUS FAMILIES/MODELS OF CELERITY CRT PACING LEADS (P070008/S027)Biotronik, Inc.2011-12-02
LUMAX 500/540 ICDS THORACIC IMPEDANCE (P050023/S047)Biotronik, Inc.2011-11-17
LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS (P000009/S046)Biotronik, Inc.2011-09-30
LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX (P050023/S046)Biotronik, Inc.2011-09-30
COROX OTW-L BP LEADS (P070008/S026)Biotronik, Inc.2011-09-30
EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S098)Biotronik, Inc.2011-09-30
COROX OTW-L BP LEADS (P070008/S025)Biotronik, Inc.2011-07-22
COROX OTW UP STEROID-ELUTING LEAD (P050023/S014)Biotronik, Inc.2011-07-01
COROX OTW (-S) BP STEROID-ELUTING LEADS (P070008/S004)Biotronik, Inc.2011-07-01
KENTROX SL/SL-S/RV/RV-S & LINOX S/SD/T/TD STEROID-ELUTING LEADS (P980023/S034)Biotronik, Inc.2011-07-01
SELOX SR/ST/JT, SETROX S, AND DEXTRUS STEROID-ELUTING LEADS (P950037/S062)Biotronik, Inc.2011-07-01
STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP (P070008/S023)Biotronik, Inc.2011-05-26
LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX (P050023/S045)Biotronik, Inc.2011-05-26
EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S096)Biotronik, Inc.2011-05-26
LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS (P000009/S045)Biotronik, Inc.2011-05-26
LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS (P980023/S044)Biotronik, Inc.2011-05-26
LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX (P050023/S044)Biotronik, Inc.2011-05-06
EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S095)Biotronik, Inc.2011-05-06
RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS (P950037/S088)Biotronik, Inc.2011-04-20
IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM (P000009/S042)Biotronik, Inc.2011-04-15
LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T (P050023/S039)Biotronik, Inc.2011-04-15
IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMING (P950037/S089)Biotronik, Inc.2011-04-15
STRATOS LV/LV-T (P070008/S019)Biotronik, Inc.2011-04-15
EVIA FAMILY OF PULSE GENERATORS (P950037/S094)Biotronik, Inc.2011-04-06
EVIA / ENTOVIS FAMILY OF PULSE GENERATORS (P950037/S091)Biotronik, Inc.2011-03-25
LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS (P980023/S043)Biotronik, Inc.2011-02-28
LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX (P050023/S041)Biotronik, Inc.2011-02-11
IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM (P000009/S043)Biotronik, Inc.2011-02-11
STRATOS LV/LV-T (P070008/S021)Biotronik, Inc.2011-02-11
ESTELLA AND EFFECTA PULSE GENERATORS (P950037/S092)Biotronik, Inc.2011-02-11
LUMAX ICDS/CRT-DS (P050023/S043)Biotronik, Inc.2011-01-20
COROX OTW-L BP LEFT VENTRICULAR PACING LEAD (P070008/S015)Biotronik, Inc.2010-12-23
LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX (P050023/S040)Biotronik, Inc.2010-12-08
PHILOS DR/DR-B/SR/SR-B/DR-T/PHILOS II DR/DR-T/SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/SR/SR-T/ENTOVIS DR/DR-T/SR/SR-T (P950037/S090)Biotronik, Inc.2010-12-08
STRATOS LV/LV-T (P070008/S020)Biotronik, Inc.2010-12-08
LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S038)Biotronik, Inc.2010-12-03
STRATOS LV/LV-T CRT-P (P070008/S017)Biotronik, Inc.2010-11-26
EVIA/ENTOVIS DR/DR-T/SR-T & VARIOUS OTHER MODELS OF PULSE GENERATORS (P950037/S083)Biotronik, Inc.2010-11-26
BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T, & XELOS DR-T ICDS (P000009/S040)Biotronik, Inc.2010-11-26
VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES (P050023/S033)Biotronik, Inc.2010-11-26
PHILOS DR/SR/PHILOS II DR /SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/ENTOVIS DR PULSE GENERATORS (P950037/S086)Biotronik, Inc.2010-09-17
COROX OTW/STRATOS LV/LV-T (P070008/S018)Biotronik, Inc.2010-09-17
LEXOS/LUMOS ICDS (P000009/S041)Biotronik, Inc.2010-09-17
LINOX SMART STEROID-ELUTING DUAL-COIL ICD LEADS (P980023/S038)Biotronik, Inc.2010-09-17
LUMAX ICDS/COROX OTW UP STEROID (P050023/S037)Biotronik, Inc.2010-09-17
PHILOS DR/SR & PHILOS II DR/SR (P950037/S085)Biotronik, Inc.2010-09-10
RELIATY/MODEL 3145 PACING SYSTEM ANALYZER (P950037/S079)Biotronik, Inc.2010-09-02
LUMAX FAMILIES OF ICDS & CRT-DS (P050023/S036)Biotronik, Inc.2010-08-20
LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S034)Biotronik, Inc.2010-08-04
VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES; COROX OTW UP STEROID LEAD (P050023/S032)Biotronik, Inc.2010-07-30
STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS (P070008/S016)Biotronik, Inc.2010-07-30
EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX (P950037/S082)Biotronik, Inc.2010-07-30
KAINOX VCS, LINOX S/T/SD/TD, KENTROX SL-S/RV-S/SL/RV STEROID, LINOX(SMART) ST/TD LEADS (P980023/S041)Biotronik, Inc.2010-07-30
LEXOS DR/DR-T/VR/VR-T AND LUMOS DR-T/VR-T ICDS (P000009/S039)Biotronik, Inc.2010-07-30
COROX OTW STEROID LV LEAD MONITORING (COSMO) (P050023/S035)Biotronik, Inc.2010-07-16
CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE (P950037/S081)Biotronik, Inc.2010-06-18
CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE (P050023/S031)Biotronik, Inc.2010-06-18
LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S030)Biotronik, Inc.2010-05-13
LINOX SD AND LINOX S FAMILY OF ICD PACING LEADS (P980023/S040)Biotronik, Inc.2010-05-13
STEROX S AND DEXTRUS FAMILY OF IMPLANTABLE PACEMAKER PULSE GENERATORS AND PROGRAMMERS (P950037/S080)Biotronik, Inc.2010-05-13
KRONOS LV-T AND LUMAX 300/340 & 500/540 HF/HF-T (P050023/S024)Biotronik, Inc.2010-05-07
EVIA/ENTOVIS PULSE GENERATORS (P070008/S011)Biotronik, Inc.2010-05-07
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