Surmodics Inc

FDA Filings

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

USANASDAQSRDXDUNS 098414659

Surmodics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3001374820
FEI Number3001374820
NameSURMODICS, INC.
Owner & OperatorSURMODICS, INC.
Contact Address9924 WEST 74TH STREET --
Eden Prairie MN 55344 US
Official Correspondent
  • SHAWN K FULLER
  • x-952-5007090-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address9924 W 74th St
EDEN PRAIRIE, MN 55344 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Surmodics, Inc.
Pounce ™ XL Thrombectomy 2024-11-21
Surmodics, Inc.
Pounce ™ Thrombectomy 2024-10-28
Surmodics, Inc.
Pounce™ Venous Thrombectomy System 2024-06-17
Surmodics, Inc.
Pounce ™ LP Thrombectomy 2024-03-27
Surmodics, Inc.
Pounce Venous Thrombectomy System 2023-11-06
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
SurVeil DCB 2023-10-12
Surmodics, Inc.
Pounce Sheath 2023-09-29
Surmodics, Inc.
Pounce ™ Thrombectomy 2023-08-24
Surmodics, Inc.
Sublime Microcatheter, 035, 200cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 035, 200cm, Straight 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 035, 150cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 035, 150cm, Straight 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 035, 135cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 035, 135cm, Straight 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 035, 90cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 035, 90cm, Straight 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 018, 200cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 018, 200cm, Straight 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 018, 150cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 018, 150cm, Straight 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 018, 65cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 018, 65cm, Straight 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 014, 200cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 014, 200cm, Straight 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 014, 150cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 014, 150cm, Straight 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 014, 65cm, Angle 2023-04-24
Surmodics, Inc.
Sublime Microcatheter, 014, 65cm, Straight 2023-04-24
Surmodics Inc.
Sublime Microcatheter2022-10-14
Surmodics, Inc.
Pounce™ Venous Thrombectomy System 2022-06-30
Surmodics Inc.
Pounce Thrombectomy System2022-03-23
Surmodics, Inc.
Pounce™ Thrombectomy System 2022-01-04
Surmodics, Inc.
Pounce Thrombectomy System2021-07-30
Surmodics, Inc.
Pounce Thrombus Retrieval System2020-09-21
Surmodics, Inc.
Guide Sheath2019-04-18
Surmodics, Inc.
Microcatheter2018-01-12

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092921872Anvers,Belgium -> New York/Newark Area, Newark, New JerseyPACKAGING SUPPLIES HS CODE 3926 90971 PKG
2020091482501Anvers,Belgium -> New York/Newark Area, Newark, New JerseyPACKAGING SUPPLIES HS CODE 3926 90971 PKG
2020090188955Anvers,Belgium -> New York/Newark Area, Newark, New JerseyPACKAGING SUPPLIES HS CODE 3926 90971 PKG
2020081853798Anvers,Belgium -> New York/Newark Area, Newark, New JerseyPACKAGING SUPPLIES HS CODE 4819101 PKG
2020080462147Anvers,Belgium -> New York/Newark Area, Newark, New JerseyPACKAGING SUPPLIES HS CODE 4819101 PKG
2020040856813Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyPACKAGING MATERIAL4 PCS

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