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SURMODICS, INC.

USA · Eden Prairie

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 0Class II 5Class III 1

plus 15 registration records and 11 510(k), 7 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States15 registration records, 11 510(k), 7 PMA, 2 excluded

Manufacturer names merged into this page: SURMODICS, INC.

FDA 510(k) clearances by year

12018

12019

12020

12021

22022

32023

12024

12025

FDA listed device types

Catheter, Continuous Flush 1Peripheral Mechanical Thrombectomy With Aspiration 1Catheter, Angioplasty, Peripheral, Transluminal 1Catheter, Percutaneous 1Introducer, Catheter 1Drug-Eluting Peripheral Transluminal Angioplasty Catheter 1

Market	Identifier	Name	Class / date
US	K252227	Pounce(TM) Sheath	2025-09-24
US	K241362	Pounce XL Thrombectomy System (PTS-1011-7F135)	2024-09-11
US	K232647	Microcatheter	2023-09-29

SURMODICS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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