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CAYENNE MEDICAL, INC.

USA · Scittsdake

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

13listed device types

Class I 9Class II 4Class III 0

plus 24 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 2Class II 6

17 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

12 including historic records

TWTaiwanTFDA

6valid device licences

Class I 1Class II 5

SGSingaporeHSA SMDR

7device registrations

CLASS B 1CLASS C 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

17active ARTG entries

Class I 7IIa 4IIb 6

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2a 1Class 2b 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 States24 registration records, 23 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: CAYENNE MEDICAL, INC. · CAYENNE MEDICAL INC.

FDA 510(k) clearances by year

22006

22007

12008

32009

12011

52012

22013

32015

12016

12017

12018

12019

FDA listed device types

showing 8 of 13

Screw, Fixation, Bone 1Fastener, Fixation, Nondegradable, Soft Tissue 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Suture Kit 1Cannula, Surgical, General & Plastic Surgery 1Reamer 1Bit, Drill 1Accessories, Arthroscopic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192428	AFX Femoral Implant with Inserter	2019-10-05
US	K180274	Ventix Link Knotless Anchor with Inserter	2018-03-21
US	K172186	BioWick X Implant with Driver	2017-10-16
BR	80044689043	Instrumental Surelock Esteril	Class II
BR	80044680430	Kit Instrumental Quattro	Class II
BR	80044689042	INSTRUMENTAIS SURELOCK	Class II

CAYENNE 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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