FDA.reportPublic FDA data

DEKA RESEARCH & DEVELOPMENT CORP.

Matched from indexed company URL: DEKA Research & Development

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12209731220973DEKA RESEARCH & DEVELOPMENT CORP.1N2026-01-01340 Commercial St Manchester NH US 03101

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1454261046608163K250930twiist systemQFG2025-04-02
1454261095674776K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionFRN2025-03-11
1454261039002250K243841Sparta Infusion Set for InsulinFPA2025-08-01
1454261717955943K243442iBOT® PMDIMK2025-01-30
1454261698747437K243354Remunity SystemQJY2024-11-27
1454261176229965K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN2025-01-16
1454261113252405K241178DEKA ACE Pump SystemQFG2024-05-24
1454262049429957K234055DEKA LoopQJI2024-03-13
1454261911424868K213536DEKA ACE Pump SystemQFG2023-07-25
1454261313536304K210920iBOT Personal Mobility Device (iBOT PMD)IMK2021-06-16
1454261729212375K202690Remunity Pump for Remodulin (treprostinil) InjectionQJY2020-12-30
1454261311437239K191313Unity Subcutaneous Infusion System for RemodulinQJY2020-02-21
1454261661621809K190182Unity Subcutaneous Delivery System for RemodulinFRN2019-05-06
1454261267108092K172601Next Generation iBOTIMK2018-03-02
1454261005652208K153760Volumetric Infusion ControllerLDR2016-10-03
1454261244937112K093915DEKA TAC DEVICEFIG2011-08-23
1454261367646317DEN120016DEKA ARM SYSTEMPAE2014-05-09
1454261935655475

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QFG32025-04-02
FRN32025-03-11
IMK32025-01-30
QJY32024-11-27
FPA12025-08-01
QJI12024-03-13
LDR12016-10-03
PAE12014-05-09
FIG12011-08-23

PMN#

DEKA Loop

2024-03-13

Deka Research and Development

DEKA JR.

1986-09-03

DEKA RESEARCH & DEVELOPMENT CORP.