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Reflow Medical, Inc.

USA · San Clemente

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel — 7 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

3listed device types

Class I 0Class II 3Class III 0

plus 25 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

3valid device licences

Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

1registrations

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 States25 registration records, 19 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: REFLOW MEDICAL, INC · Reflow Medical · REFLOW MEDICAL, INC.

FDA 510(k) clearances by year

12010

12012

12013

22014

12015

12016

22017

12018

12019

42020

12021

12024

22025

FDA listed device types

Peripheral Temporary And Retrievable Stent System 1Catheter, Percutaneous 1Catheter For Crossing Total Occlusions 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251277	CoraForce Microcatheter, CoraFlex Microcatheter	2025-08-22
US	DEN240048	Spur Peripheral Retrievable Stent System	2025-05-29
US	K233350	SINC Support Catheter	2024-02-08
BR	82392089014	Micro Cateter Guia de Suporte Modelável Spex/Spex LP	Class II
BR	82392089011	Cateter Cruzamento Wingman	Class II
BR	82392089012	Cateter Cruzamento Wingman	Class II

Reflow Medical, 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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