FDA.reportPublic FDA data

ORBUSNEICH MEDICAL TRADING, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30141482203014148220ORBUSNEICH MEDICAL TRADING, INC.1Y2020-04-255363 NW 35th Avenue Fort Lauderdale FL US 33309

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2127281872753239K192344Sapphire NC Plus Coronary Dilatation CatheterLOX2019-09-19
2127281421049626K182713Scoreflex PTA Scoring Balloon CatheterPNO2019-06-11
2127281427625989K182360Teleport MicrocatheterDQY2018-11-09
2127281994465452K180921Sapphire II PRO Balloon Dilatation CatheterLOX2018-06-28
2127281131183579K173894Jade PTA Balloon Dilatation CatheterLIT2018-02-09
2127281415000474K173680Sapphire II PROLOX2018-03-01
2127281153131866K163114Sapphire II PROLOX2017-01-05
2127281273801764K162209Sapphire NC PlusLOX2016-10-06
2127281797253375K103808SAPPHIRE NCLOX2011-09-01
2127281836407263K103657SAPPHIRELOX2011-08-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX72019-09-19
PNO12019-06-11
DQY12018-11-09
LIT12018-02-09

PMN#