HomeUSAKendall Healthcare Products Co. Div.Of Tyco Health

Kendall Healthcare Products Co. Div.Of Tyco Health

USA · Mansfield
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
74510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 74 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class I 2Class II 8
12 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
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 States0 registration records, 74 510(k), 0 PMA, 8 excluded
Brazil10 confirmed, 2 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: KENDALL, A DIVISION OF TYCO HEALTHCARE GROUP LP · COVIDIEN, anteriormente registrada como Kendall, a division of Tyco Healthcare Group LP · KENDALL HEALTH CARE PRODUCTS COMPANY - DIVISION OF TYCO HEALTHCARE GROUP, LP

Company information

Country
USA
City
Mansfield

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.

FDA 510(k) clearances by year

31983
51989
91990
41991
51992
161993
91994
61995
31996
91997
12003
22004
12005
12006

Registration details (sample)

MarketIdentifierNameClass / date
USK060339KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY2006-04-28
USK051805KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE2005-10-13
USK040511SCD EXPRESS PORTABLE COMPRESSION SYSTEM2004-06-28
BR10349000123CATETER PERITONEAL CURL CATH QUINTONClass II
BR10349000339EQUIPO KANGAROO 924 E ACESSÓRIOSClass II
BR10349000383CATETER TENCKOFF QUINTON E ACESSORIOSClass II

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