FDA.reportPublic FDA data

CROOM PRECISION MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091855913009185591CROOM PRECISION MEDICAL1N2026-01-01SFADCO Enterprise Centre Croom Limerick(County) IE V35YD39

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1532791184746716K994207HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEEKRO2000-03-13
1532791214369476K910500HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEMJWH1991-05-06
1532791984984559K904208KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEMJWH1991-04-01
1532791368551774K051380TRIATHLON PRESS-FIT TOTAL KNEE SYSTEMMBH2005-08-30
1532791997290742K002552HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEEKRO2000-11-13
1532791635293024
1532791595537498
1532791814606876

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KRO22000-11-13
JWH21991-05-06
MBH12005-08-30