HomeUSAVycor Medical, Inc.

Vycor Medical, Inc.

USA · Boca Raton
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel, Russia — 6 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
2listed device types
Class I 1Class II 1Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 3Class II 2
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
1 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class III 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 3 1
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 States3 registration records, 2 510(k), 0 PMA
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: VYCOR MEDICAL INC · VYCOR MEDICAL INC. · Vycor Medical Inc

Company information

Country
USA
City
Boca Raton

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
VYCOR MEDICAL INC
CIK
0001424768
Registration status
Active
Listing status
Listed (VYCO)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12006 · K060973
12021 · K202694

FDA listed device types

Retractor, Self-Retaining, For Neurosurgery 1Clamp, Surgical, General & Plastic Surgery 1

Registration details (sample)

MarketIdentifierNameClass / date
USK202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)2021-01-14
USK060973VYCOR SURGICAL ACCESS SYSTEMS2006-07-26
BR10275160040Vycor Extension ArmClass I
BR10275160043VBAS RetractorClass I
BR10275160042VBASClass II

Similar companies

Abaxis
USA · markets 9
Accorto Regulatory Solutions LLC
USA · markets 0
Accumold LLC
USA · markets 1
AccuVein Inc.
USA · markets 8
Acme Monaco Corporation
USA · markets 4
ACON Laboratories, Inc.
USA · markets 9
Is this your company? Claim the page, add information or report a data error.Claim / report an error →