FDA.reportPublic FDA data

HARMAC MEDICAL PRODUCTS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036305043002468842HARMAC MEDICAL PRODUCTS1N2026-01-01I.D.A. BUSINESS PARK CASTLEREA Roscommon IE --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
309281165188217K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)MSD2018-02-08
309282048728848K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX CanistersOMP2015-04-29
309281012053063K132815PUREGRAFT 50 SYSTEMMUU2014-01-24
309281665587671K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEDTL2012-09-07
309281293101252K113255PUREGRAFT 850/PURE SYSTEMMUU2012-03-07
309281683831935K092923CYTORI PUREGRAFT 250/PURE SYSTEMMUU2010-01-06
309281010934677
309281097775874
309281149851598
309281325157840
309281575765460
309281906933982
309281997328448
309281999103685
309282014567184
309282019310946
309282048728848

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUU32014-01-24
MSD12018-02-08
OMP12015-04-29
DTL12012-09-07