Home›USA›F Care Systems USA, LLC

F Care Systems USA, LLC

USA · Miami

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

4listed device types

Class I 1Class II 3Class III 0

plus 5 registration records and 4 510(k)

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

1active device licences

Class III 1

2 including historic records

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 States5 registration records, 4 510(k), 0 PMA, 627 excluded

Brazil0 confirmed, 47 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada1 confirmed, 68 excluded

Manufacturer names merged into this page: F CARE SYSTEMS USA · SIEMENS MEDICAL SOLUTIONS USA, INC. ONCOLOGY CARE SYSTEMS

FDA 510(k) clearances by year

12021 · K210077

12023 · K220725

12025 · K252704

12026 · K253918

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Catheter, Intravascular Occluding, Temporary 1Electrosurgical Coagulation For Aesthetic 1Catheter, Pediatric, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253918	Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)	2026-06-02
US	K252704	F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)	2025-11-24
US	K220725	HPR45i	2023-03-20
CA	15152	SIMVIEW NT	Class III

F Care Systems USA, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies