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Biotronik AG

138 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Astron (P140030/S022)Biotronik AG2025-12-17
Astron Pulsar; Pulsar-18; Pulsar-18 T3 (P160025/S023)Biotronik AG2025-12-17
Pulsar-18 T3 Stent System (P160025/S022)Biotronik AG2025-10-21
Astron Peripheral Self- Expanding Nitinol Stent System (P140030/S021)Biotronik AG2025-10-21
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S056)Biotronik AG2025-10-10
Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System (P170030/S055)Biotronik AG2025-08-19
Astron (P140030/S019)Biotronik AG2025-07-16
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S057)Biotronik AG2025-07-10
Astron Pulsar; Pulsar-18; Pulsar-18 T3 (P160025/S020)Biotronik AG2025-07-10
Astron (P140030/S018)Biotronik AG2025-07-10
PRO-Kinetic Energy Coronary Stent System (P160003/S025)Biotronik AG2025-07-10
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S054)Biotronik AG2025-05-15
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S051)Biotronik AG2025-04-11
ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S053)Biotronik AG2025-04-09
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S048)Biotronik AG2025-03-03
Astron (P140030/S017)Biotronik AG2025-03-03
Pulsar-18 T3 (P160025/S019)Biotronik AG2025-03-03
PRO-Kinetic Energy Coronary Stent System (P160003/S023)Biotronik AG2025-02-14
ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S050)Biotronik AG2025-02-14
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S049)Biotronik AG2025-02-14
Pulsar-18 T3 Stent System (P160025/S018)Biotronik AG2024-12-11
ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S041)Biotronik AG2024-12-11
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S044)Biotronik AG2024-10-17
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S045)Biotronik AG2024-10-15
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S046)Biotronik AG2024-09-26
Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System (P170030/S042)Biotronik AG2024-09-24
ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S043)Biotronik AG2024-08-14
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S040)Biotronik AG2024-07-24
ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S039)Biotronik AG2024-06-06
PRO-Kinetic Energy Coronary Stent System (P160003/S021)Biotronik AG2024-05-17
Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S038)Biotronik AG2024-05-17
ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S033)Biotronik AG2024-05-08
PRO-Kinetic Energy Coronary Stent System (P160003/S020)Biotronik AG2024-04-24
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S037)Biotronik AG2024-04-24
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S036)Biotronik AG2024-03-26
PRO-Kinetic Energy Coronary Stent System (P160003/S019)Biotronik AG2024-03-26
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S028)Biotronik AG2023-12-21
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S034)Biotronik AG2023-10-26
ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S032)Biotronik AG2023-08-25
ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S031)Biotronik AG2023-08-24
PRO-KINETIC ENERGY CORONARY STENT SYSTEM (P160003/S018)Biotronik AG2023-08-16
PRO-Kinetic Energy Coronary Stent System (P160003/S017)Biotronik AG2023-08-07
ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S030)Biotronik AG2023-08-07
Astron Pulsar, Pulsar-18, Pulsar-18 T3 (P160025/S017)Biotronik AG2023-07-20
Astron (P140030/S016)Biotronik AG2023-07-20
Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S029)Biotronik AG2023-06-15
Pulsar-18 T3 Stent System (P160025/S016)Biotronik AG2023-05-23
Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System (P170030/S023)Biotronik AG2023-03-22
Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Siroiimus Eiuting Coronary Stent System (P170030/S027)Biotronik AG2023-03-03
PRO-Kinetic Energy Coronary Stent System (P160003/S016)Biotronik AG2023-03-03
ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S025)Biotronik AG2023-01-26
Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S022)Biotronik AG2022-08-31
Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System (P170030/S026)Biotronik AG2022-08-05
Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S015)Biotronik AG2022-07-27
PRO-Kinetic Energy Coronary Stent System (P160003/S015)Biotronik AG2022-07-27
Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S024)Biotronik AG2022-07-27
Astron Pulsar Stent System, Pulsar-18 Stent System (P160025/S015)Biotronik AG2022-07-27
Pulsar-18 T3 Stent System (P160025/S013)Biotronik AG2022-07-20
Pulsar-18 Stent Systems (P160025/S014)Biotronik AG2022-05-20
ORSIRO Sirolimus Eluting Coronary Stent System and Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S021)Biotronik AG2022-02-23
ORSIRO Sirolimus Eluting Coronary Stent System, ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S019)Biotronik AG2022-02-18
ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S020)Biotronik AG2021-12-09
Astron Pulsar Stent System (P160025/S012)Biotronik AG2021-10-14
Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S014)Biotronik AG2021-10-14
ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S018)Biotronik AG2021-07-28
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S017)Biotronik AG2021-07-13
PRO-Kinetic Energy Coronary Stent System (P160003/S014)Biotronik AG2021-07-13
Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S007)Biotronik AG2021-06-24
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S016)Biotronik AG2021-05-06
PRO-Kinetic Energy Coronary Stent System (P160003/S013)Biotronik AG2021-05-06
Astron Peripheral Self- Expanding Nitinol Stent System (P140030/S013)Biotronik AG2021-05-06
Astron Pulsar Stent System (P160025/S011)Biotronik AG2021-05-06
Astron Pulsar Stent System and Pulsar-18 Stent System (P160025/S010)Biotronik AG2021-04-23
Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S012)Biotronik AG2021-04-23
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S015)Biotronik AG2021-04-23
PRO-Kinetic Energy Coronary Stent System (P160003/S012)Biotronik AG2021-04-23
ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S014)Biotronik AG2021-02-17
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S012)Biotronik AG2020-11-13
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S013)Biotronik AG2020-11-13
ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S011)Biotronik AG2020-10-30
ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S010)Biotronik AG2020-10-21
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S008)Biotronik AG2020-08-20
PRO-Kinetic Energy Coronary Stent System (P160003/S011)Biotronik AG2020-08-20
PRO-Kinetic Energy Stent System (P160003/S010)Biotronik AG2020-08-06
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S006)Biotronik AG2020-06-15
Astron Pulsar Stent System (P160025/S007)Biotronik AG2020-01-23
PRO-Kinetic Energy Coronary Stent System (P160003/S007)Biotronik AG2020-01-23
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S001)Biotronik AG2020-01-23
Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S009)Biotronik AG2020-01-23
PRO-Kinetic Energy Coronary Stent System (P160003/S009)Biotronik AG2019-12-04
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S005)Biotronik AG2019-12-04
Astron Pulsar Stent System and Pulsar-18 Stent System (P160025/S009)Biotronik AG2019-12-04
Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S011)Biotronik AG2019-12-04
ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S002)Biotronik AG2019-11-12
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S004)Biotronik AG2019-10-25
Orsiro Sirolimus Eluting Coronary Stent System (P170030/S003)Biotronik AG2019-08-29
Astron Pulsar/Pulsar-18 Stent Systems (P160025/S008)Biotronik AG2019-08-14
Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S010)Biotronik AG2019-08-14
PRO-Kinetic Energy Coronary Stent System, Papyrus (P160003/S008)Biotronik AG2019-06-05
PRO-Kinetic Energy Coronary Stent System (P160003/S006)Biotronik AG2019-04-25
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Every clearance here is in the API, with alerts when new ones post.