Iradimed Corp

FDA Filings

This page includes the latest FDA filings for Iradimed Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USA

NASDAQ

IRMD

DUNS 170301969

FDA Registration(s)

• Registration Number: 3005053560
• FEI Number: 3005053560
• Name: IRADIMED CORPORATION
• Owner & Operator: IRADIMED CORPORATION
• Contact Address: 1025 WILLA SPRINGS DRIVE --; Winter Springs FL 32708 US
• Official Correspondent:
  • FRANCIS X CASEY
  • x-407-6778022-206
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1025 Willa Springs Dr ; Winter Springs, FL 32708 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 00856038001874 IRADIMED CORP.	Iradimed 3883-3	2022-06-28
GUDID 00856038001379 IRADIMED CORP.	Iradimed 3883-2	2022-06-28
GUDID 00856038001362 IRADIMED CORP.	Iradimed 3883-1	2022-06-28
GUDID 00856038001355 IRADIMED CORP.	Iradimed 3880-4	2022-06-17
GUDID 00856038001331 IRADIMED CORP.	Iradimed 3880-3	2022-06-17
GUDID 00856038001324 IRADIMED CORP.	Iradimed 3880-2	2022-06-17
GUDID 00856038001249 IRADIMED CORP.	Iradimed 3880-1	2022-06-17
GUDID 00856038001294 IRADIMED CORP.	Iradimed 1834SA-10	2021-04-23
GUDID 00856038001270 IRADIMED CORP.	Iradimed 1834I-10	2021-04-23
GUDID 00856038001263 IRADIMED CORP.	Iradimed 1834C-10	2021-04-23
GUDID 00856038001256 IRADIMED CORP.	Iradimed 1834AL-10	2021-04-23
GUDID 00856038001751 IRADIMED CORP.	Iradimed 1888	2020-08-28
GUDID 00856038001744 IRADIMED CORP.	Iradimed 3883	2020-08-28
GUDID 00856038001713 IRADIMED CORP.	Iradimed 1119M	2020-08-28
GUDID 00856038001836 IRADIMED CORP.	Iradimed IVP1054	2020-04-22
GUDID 00856038001829 IRADIMED CORP.	Iradimed 1190-12	2020-02-17
GUDID 00856038001812 IRADIMED CORP.	Iradimed 1195	2020-02-17
GUDID 00856038001157 IRADIMED CORP.	Iradimed 1145	2020-01-22
GUDID 00856038001805 IRADIMED CORP.	Iradimed 1863	2019-09-19
GUDID 00856038001799 IRADIMED CORP.	Iradimed 1862	2019-09-19
GUDID 00856038001782 IRADIMED CORP.	Iradimed 1861	2019-09-19
GUDID 00856038001690 IRADIMED CORP.	Iradimed 1846-25	2019-08-21
GUDID 00856038001447 IRADIMED CORP.	Iradimed 1841-25	2019-08-21
GUDID 00856038001775 IRADIMED CORP.	Iradimed 1832A-LONG	2019-07-22
GUDID 00856038001492 IRADIMED CORP.	Iradimed 1832I	2019-07-22
GUDID 00856038001485 IRADIMED CORP.	Iradimed 1832P	2019-07-22
GUDID 00856038001478 IRADIMED CORP.	Iradimed 1832SA	2019-07-22
GUDID 00856038001461 IRADIMED CORP.	Iradimed 1832A	2019-07-22
GUDID 00856038001454 IRADIMED CORP.	Iradimed 1832LA	2019-07-22
PMN K180903 Iradimed Corporation	3880 MRI Patient Monitoring System	2019-03-29
GUDID 00856038001706 IRADIMED CORP.	Iradimed 1845-25	2019-01-23
PMN K182900 Iradimed Corporation	3880 MRI Patient Monitoring System	2018-12-14
GUDID 10856038001055 IRADIMED CORP.	Iradimed IVP1058	2018-07-06
GUDID 10856038001024 IRADIMED CORP.	Iradimed IVP1056	2018-07-06
GUDID 00856038001683 IRADIMED CORP.	Iradimed 1171	2018-07-06
GUDID 00856038001676 IRADIMED CORP.	Iradimed 1884	2018-07-06
GUDID 00856038001669 IRADIMED CORP.	Iradimed 1883	2018-07-06
GUDID 00856038001645 IRADIMED CORP.	Iradimed 1882-3	2018-07-06
GUDID 00856038001638 IRADIMED CORP.	Iradimed 1831	2018-07-06
GUDID 00856038001621 IRADIMED CORP.	Iradimed 1891	2018-07-06
GUDID 00856038001614 IRADIMED CORP.	Iradimed 1844P-25	2018-07-06
GUDID 00856038001607 IRADIMED CORP.	Iradimed 1844A-25	2018-07-06
GUDID 00856038001591 IRADIMED CORP.	Iradimed 1843P-25	2018-07-06
GUDID 00856038001584 IRADIMED CORP.	Iradimed 1843A-25	2018-07-06
GUDID 00856038001577 IRADIMED CORP.	Iradimed 1842P-25	2018-07-06
GUDID 00856038001560 IRADIMED CORP.	Iradimed 1842I-25	2018-07-06
GUDID 00856038001553 IRADIMED CORP.	Iradimed 1842A-25	2018-07-06
GUDID 00856038001546 IRADIMED CORP.	Iradimed 1851	2018-07-06
GUDID 00856038001539 IRADIMED CORP.	Iradimed 1833N4-10	2018-07-06
GUDID 00856038001522 IRADIMED CORP.	Iradimed 1833N3-10	2018-07-06
GUDID 00856038001515 IRADIMED CORP.	Iradimed 1833N2-10	2018-07-06
GUDID 00856038001508 IRADIMED CORP.	Iradimed 1833N1-10	2018-07-06
GUDID 00856038001430 IRADIMED CORP.	Iradimed 1822N-25	2018-07-06
GUDID 00856038001423 IRADIMED CORP.	Iradimed 1822P-25	2018-07-06
GUDID 00856038001416 IRADIMED CORP.	Iradimed 1822I-25	2018-07-06
GUDID 00856038001409 IRADIMED CORP.	Iradimed 1822A-25	2018-07-06
GUDID 00856038001393 IRADIMED CORP.	Iradimed 1887	2018-07-06
GUDID 00856038001386 IRADIMED CORP.	Iradimed 1881	2018-07-06
GUDID 00856038001348 IRADIMED CORP.	Iradimed 1811	2018-07-06
GUDID 00856038001232 IRADIMED CORP.	Iradimed 1188	2018-07-06
GUDID 00856038001225 IRADIMED CORP.	Iradimed 3886	2018-07-06
GUDID 00856038001218 IRADIMED CORP.	Iradimed 3885B	2018-07-06
GUDID 00856038001201 IRADIMED CORP.	Iradimed 3885T	2018-07-06
GUDID 00856038001195 IRADIMED CORP.	Iradimed 3882	2018-07-06
GUDID 00856038001188 IRADIMED CORP.	Iradimed 3881	2018-07-06
GUDID 00856038001171 IRADIMED CORP.	Iradimed 3880	2018-07-06
GUDID 00856038001164 IRADIMED CORP.	Iradimed 1170	2018-07-06
GUDID 00856038001140 IRADIMED CORP.	Iradimed 1133	2018-07-06
GUDID 00856038001133 IRADIMED CORP.	Iradimed 1128	2018-07-06
GUDID 00856038001126 IRADIMED CORP.	Iradimed 1122	2018-07-06
GUDID 00856038001119 IRADIMED CORP.	Iradimed 1121	2018-07-06
GUDID 00856038001102 IRADIMED CORP.	Iradimed 1120	2018-07-06
GUDID 00856038001096 IRADIMED CORP.	Iradimed 3865	2018-07-06
GUDID 00856038001089 IRADIMED CORP.	Iradimed 3860+	2018-07-06
GUDID 00856038001072 IRADIMED CORP.	Iradimed 3861	2018-07-06
GUDID 00856038001041 IRADIMED CORP.	Iradimed IVP1057	2018-07-06
GUDID 00856038001652 IRADIMED CORP.	Iradimed 1812-25	2018-03-29
GUDID 00856038001065 IRADIMED CORP.	Iradimed 1119	2018-03-29
PMN K172200 | MWI IRADIMED CORPORATION	3880 MRI Patient Monitoring System	2017-11-13
DRX IRADIMED CORPORATION	Hextrode MRI ECG Electrode	2017-11-13
PMN K172200 Iradimed Corporation	3880 MRI Patient Monitoring System	2017-10-25
PMN K143369 IRADIMED CORPORATION	MRidium 3860+ MRI Infusion Pump/ Monitoring System	2016-12-15
PMN K090087 | FRN IRADIMED CORPORATION	MRidium 3860 System	2009-12-28
PMN K090087 | FRN IRADIMED CORPORATION	MRidium 3860 MRI Infusion Pump System	2009-12-28
PMN K090087 IRADIMED CORPORATION	MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM	2009-04-07
PMN K050301 | FRN IRADIMED CORPORATION	MRidium	2008-02-21
PMN K050301 | FRN IRADIMED CORPORATION	MRidium 3850 MRI Infusion Pump System	2008-02-21
FOX IRADIMED CORPORATION	MRidium IV Pole	2005-04-11
FOX IRADIMED CORPORATION	MRIDIUM 3850 SERIES MRI INF	2005-04-11
PMN K050301 IRADIMED CORPORATION	MRIDIUM 3850 MRI PUMP SYSTEM	2005-03-24

Related Finance Registrations

NCAGE Code	5BA46	IRADIMED CORP.
CAGE Code	5BA46	IRADIMED CORP.
S.A.M. Registration	5BA46 [170301969]	IRADIMED CORP.
SEC	0001325618	IRADIMED CORP

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090463097	Yantian,China (Mainland) -> Long Beach, California	STEEL INJECTION MOLD	1 PKG
2020090255575	Yantian,China (Mainland) -> Long Beach, California	STEEL INJECTION MOLD	1 PKG
2020090179833	Yantian,China (Mainland) -> Long Beach, California	STEEL INJECTION MOLD	1 PKG
202007257852	Ningpo ,China (Mainland) -> Miami, Florida	CASTING POLE LEG	50 CTN
2020052711671	Rotterdam,Netherlands -> Charleston, South Carolina	OPERATING TABLES HTS 94029000	4 PKG
202005219573	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PLASTIC COVER	21 CTN
2020051828653	Rotterdam,Netherlands -> Charleston, South Carolina	OPERATING TABLES HTS 94029000	4 PKG
2020050745437	Kaohsiung,China (Taiwan) -> Los Angeles, California	PUMP PARTS ========== PUMP PARTS- CLAMP HANDL ALUMINUM,3851 PUMP PARTS- CLAMP HANDLE,DOOR, 3851/61,LATCHED PUMP PARTS- CHASSIS	126 CTN