FDA.reportPublic FDA data

KORU MEDICAL SYSTEMS, INC.

Matched from indexed company URL: Koru Medical Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30241229533024122953KORU MEDICAL SYSTEMS, INC.1N2026-01-01100 Corporate Drive Mahwah NJ US 07430

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3089801389663381K933652FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBINGFRN1994-05-18
3089801802864155K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN2026-01-28
3089801857742555K231918Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe AdapterFRN2023-11-03
3089801484938067K214045FreedomEdge Syringe Infusion SystemFRN2022-04-29
3089801318730763K211206FreedomEdge(R) Syringe Infusion SystemFRN2021-11-09
3089801789442445K200176FREEDOM Integrated Syringe Infusion SystemFRN2021-12-15
3089801471065730K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemFRN2017-08-31
3089801327795050K122404MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26FPA2013-05-06
3089801194540536K102512RMS SUBCUTANEOUS NEEDLE SETFPA2011-05-20
3089801409721723

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRN72026-01-28
FPA22013-05-06

PMN#