Atlas FDA

General Hospital

810 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S381)Medtronic, Inc.2021-10-28
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S377)Medtronic, Inc.2021-10-12
Implantable System for Remodulin (P140032/S074)Medtronic, Inc.2021-08-31
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S368)Medtronic, Inc.2021-08-30
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S376)Medtronic, Inc.2021-07-21
Implantable System for Remodulin (P140032/S073)Medtronic, Inc.2021-07-21
Implantable System for Remodulin (P140032/S072)Medtronic, Inc.2021-06-25
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S375)Medtronic, Inc.2021-06-25
Intera Hepatic Artery Infusion Pump (P890055/S074)Intera Oncology2021-06-22
Implantable System for Remodulin (P140032/S071)Medtronic, Inc.2021-06-02
SynchroMed Infusion System (P860004/S374)Medtronic, Inc.2021-06-02
Implantable System for Remodulin (P140032/S070)Medtronic, Inc.2021-05-04
SynchroMed® Infusion System (P860004/S373)Medtronic, Inc.2021-05-04
SynchroMed Infusion System, Ascenda® IntrathecaI Catheters (P860004/S372)Medtronic, Inc.2021-05-03
Implantable System for Remodulin (P140032/S069)Medtronic, Inc.2021-05-03
Intera 3000 Hepatic Artery Infusion Pump accessories (P890055/S077)Intera Oncology2021-04-13
Implantable System for Remodulin (P140032/S068)Medtronic, Inc.2021-04-01
SynchroMed Infusion System (P860004/S371)Medtronic, Inc.2021-04-01
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S370)Medtronic, Inc.2021-03-31
Implantable System for Remodulin (P140032/S067)Medtronic, Inc.2021-03-25
Drug Delivery Infusion Pumps SynchroMed (P860004/S369)Medtronic, Inc.2021-03-25
Prometra Programmable Infusion Pump System (P080012/S069)Infusyn Therapeutics, LLC2021-03-02
Medstream Programmable Infusion Pump System (P890055/S075)Intera Oncology2021-01-22
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S361)Medtronic, Inc.2021-01-15
Implantable System for Remodulin (ISR) (P140032/S058)Medtronic, Inc.2021-01-15
Implantable System for Remodulin (P140032/S065)Medtronic, Inc.2021-01-08
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S367)Medtronic, Inc.2021-01-08
Prometra Programmable Infusion Pump System (P080012/S056)Infusyn Therapeutics, LLC2020-12-30
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S366)Medtronic, Inc.2020-12-18
Implantable System for Remodulin (P140032/S064)Medtronic, Inc.2020-12-18
Codman OR Prep Kits (P890055/S076)Intera Oncology2020-12-16
Implantable System for Remodulin (P140032/S063)Medtronic, Inc.2020-11-30
SynchroMed Infusion System (P860004/S365)Medtronic, Inc.2020-11-30
Implantable System for Remodulin (P140032/S062)Medtronic, Inc.2020-11-19
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S364)Medtronic, Inc.2020-11-19
Implantable System for Remodulin (P140032/S061)Medtronic, Inc.2020-11-18
SynchroMed Intrathecal Catheters (P860004/S363)Medtronic, Inc.2020-11-18
SynchroMed Infusion System (P860004/S352)Medtronic, Inc.2020-11-10
Implantable System for Remodulin (ISR) (P140032/S049)Medtronic, Inc.2020-11-10
Prometra Programmable Infusion Pump System (P080012/S067)Infusyn Therapeutics, LLC2020-10-29
Implantable System for Remodulin (P140032/S047)Medtronic, Inc.2020-10-21
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S360)Medtronic, Inc.2020-09-22
Implantable System for Remodulin (P140032/S057)Medtronic, Inc.2020-09-22
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S362)Medtronic, Inc.2020-09-09
Implantable System for Remodulin (P140032/S060)Medtronic, Inc.2020-09-09
Implantable System for Remodulin (P140032/S059)Medtronic, Inc.2020-09-06
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S338)Medtronic, Inc.2020-08-21
Implantable System for Remodulin (P140032/S056)Medtronic, Inc.2020-06-09
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S359)Medtronic, Inc.2020-06-09
Implantable System for Remodulin (P140032/S055)Medtronic, Inc.2020-05-20
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S358)Medtronic, Inc.2020-05-20
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S345)Medtronic, Inc.2020-05-15
Implantable System for Remodulin (P140032/S054)Medtronic, Inc.2020-05-14
SynchroMed Infusion System (P860004/S357)Medtronic, Inc.2020-05-14
Implantable System for Remodulin (P140032/S053)Medtronic, Inc.2020-05-08
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S356)Medtronic, Inc.2020-05-08
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S355)Medtronic, Inc.2020-04-22
Implantable System for Remodulin (P140032/S052)Medtronic, Inc.2020-04-22
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S354)Medtronic, Inc.2020-04-07
Implantable System for Remodulin (P140032/S051)Medtronic, Inc.2020-04-07
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S353)Medtronic, Inc.2020-04-02
Implantable System for Remodulin (P140032/S050)Medtronic, Inc.2020-04-02
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S334)Medtronic, Inc.2020-03-23
IsoMed Infusion System (P990034/S039)Medtronic, Inc.2020-03-23
Prometra II Programmable Infusion Pump System (P080012/S065)Infusyn Therapeutics, LLC2020-03-17
3000 Series Implantable Infusion Pump and the MedStream Programmable Infusion System and Accessories (P890055/S073)Intera Oncology2020-02-07
INFUSAID Implantable Infusion Pump and Accessories (P800036/S041)Intera Oncology2020-02-07
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S346)Medtronic, Inc.2020-02-03
SynchroMed Infusion System, Ascenda Intrathecal Catheter (P860004/S351)Medtronic, Inc.2020-01-22
Implantable System for Remodulin (P140032/S048)Medtronic, Inc.2020-01-22
Prometra II Programmable Infusion Pump System (P080012/S057)Infusyn Therapeutics, LLC2020-01-15
Prometra Programmable Infusion Pump System (P080012/S064)Infusyn Therapeutics, LLC2020-01-15
Implantable System for Remodulin (P140032/S046)Medtronic, Inc.2020-01-09
Implantable System for Remodulin (P140032/S045)Medtronic, Inc.2020-01-09
Drug Delivery Infusion Pumps SynchroMed (P860004/S349)Medtronic, Inc.2020-01-09
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S350)Medtronic, Inc.2020-01-09
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S348)Medtronic, Inc.2019-12-19
Implantable System for Remodulin (P140032/S044)Medtronic, Inc.2019-12-19
Implantable System for Remodulin (P140032/S043)Medtronic, Inc.2019-12-11
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S347)Medtronic, Inc.2019-12-11
Prometra Programmable Infusion Pump System (P080012/S061)Infusyn Therapeutics, LLC2019-11-08
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S344)Medtronic, Inc.2019-10-24
Implantable System for Remodulin (P140032/S042)Medtronic, Inc.2019-10-24
Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.28 (P080012/S062)Infusyn Therapeutics, LLC2019-10-22
SynchroMed Infusion System, Ascenda Intratecal Catheters (P860004/S330)Medtronic, Inc.2019-10-16
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S343)Medtronic, Inc.2019-10-13
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S336)Medtronic, Inc.2019-10-08
Implantable System for Remodulin (P140032/S036)Medtronic, Inc.2019-10-02
SynchroMed (SM) Infusion System (P860004/S342)Medtronic, Inc.2019-10-01
Implantable System for Remodulin (P140032/S041)Medtronic, Inc.2019-09-27
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S341)Medtronic, Inc.2019-09-27
Prometra Programmable Infusion Pump System (P080012/S060)Infusyn Therapeutics, LLC2019-09-23
SynchroMed Infusion System (P860004/S325)Medtronic, Inc.2019-09-06
Implantable System for Remodulin (P140032/S040)Medtronic, Inc.2019-09-04
SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S339)Medtronic, Inc.2019-09-04
Implantable System for Remodulin (P140032/S039)Medtronic, Inc.2019-08-27
Implantable System for Remodulin (P140032/S038)Medtronic, Inc.2019-08-20
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S337)Medtronic, Inc.2019-08-20
Implantable System for Remodulin (P140032/S037)Medtronic, Inc.2019-08-14
SynchroMed Infusion System Ascenda Intrathecal Catheters (P860004/S335)Medtronic, Inc.2019-08-14
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Every clearance here is in the API, with alerts when new ones post.