FDA.reportPublic FDA data

HARMAC MEDICAL PRODUCTS, INC.

Matched from indexed company URL: HARMAC MEDICAL PRODUCTS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13175471317547HARMAC MEDICAL PRODUCTS, INC.1N2026-01-012201 BAILEY AVE. BUFFALO NY US 14211
30036305043002468842HARMAC MEDICAL PRODUCTS1N2026-01-01I.D.A. BUSINESS PARK CASTLEREA Roscommon IE --
30111636683011163668HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de R.L. de C.V.1N2026-01-01Calle Maquiladoras No. 320-A Col. Ciudad Industrial Tijuana Baja California MX C.P. 22444

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
309261125687753K950895HARMAC EXTENSION INFUSION SETFPA1995-09-01
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
309261100409920K090736POWER INFUSER, MODEL M100B-3AFRN2009-05-20
309261909555748K021916HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001FPA2002-08-29
1744561590793943
309281010934677
1744561033967531
309261097775874
309281097775874
309261122363612
309281149851598
309261160671726
1744561175138459
309261197907463
309261199068379
1744561225478811
309261225478811
309261228009636
309261245128592
309261275060911
309261289778915
1744561297020352
309281325157840
1744561429550473
309261455567536
1744561455567536
309261501839381
309261601086310
309261620513586
1744561711581864
309261742134329
309261748399735
309261764854710
309261854188098
309281906933982
309261911682876
1744561963241094
309281997328448
309281999103685
309262002718243
1744562002718243
309282014567184
309282019310946
309282048728848
309262048728848
309262069800030

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUU32014-01-24
FPA22002-08-29
MSD12018-02-08
OMP12015-04-29
DTL12012-09-07
FRN12009-05-20

PMN#