FDA.reportPublic FDA data

ORBUSNEICH MEDICAL, INC.

Matched from indexed company URL: OrbusNeich Medical, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10644983014148220ORBUSNEICH MEDICAL, INC.1Y2026-01-013350 SW 148th Ave, Suite 110, Miramar, FL 33027, US Miramar FL US 33027
30037751863003775186OrbusNeich Medical (Shenzhen) Co., Ltd.1N2026-01-01No.1st Jinkui Road, FUTIAN FREE TRADE ZONE, Shenzhen, China; Floor 1 and Floor 3, Tower D, Tong'an industrial SHENZHEN Guangdong CN 518038
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
206761650528384P200041Scoreflex NC Scoring PTCA CatheterNWX2021-12-21
206761722584347K253361Teleport Glide MicrocatheterDQY2026-04-10
206761278438823K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)DQY2025-01-07
206761604979848K241025JADE PLUS PTA Balloon Dilatation CatheterLIT2024-06-11
206761195023739K233505Sapphire ULTRA Coronary Dilatation CatheterLOX2024-08-15
206761007076172K233499Sapphire NC ULTRA Coronary Dilatation CatheterLOX2024-08-16
206761254273735K231608Teleport XT MicrocatheterDQY2024-01-07
206761603820434K211807Sapphire NC 24LOX2021-10-14
206761210036672K202231JADELIT2020-12-10
206761030566762K201794JadeLIT2020-07-28
206772026341231K200269Sapphire II PROLOX2020-03-04
206762026341231K200269Sapphire II PROLOX2020-03-04
2127281872753239K192344Sapphire NC Plus Coronary Dilatation CatheterLOX2019-09-19
2127281421049626K182713Scoreflex PTA Scoring Balloon CatheterPNO2019-06-11
206761983561807K182713Scoreflex PTA Scoring Balloon CatheterPNO2019-06-11
206761346228834K182360Teleport MicrocatheterDQY2018-11-09
2127281427625989K182360Teleport MicrocatheterDQY2018-11-09
206761296981500K180921Sapphire II PRO Balloon Dilatation CatheterLOX2018-06-28
2127281994465452K180921Sapphire II PRO Balloon Dilatation CatheterLOX2018-06-28
2127281131183579K173894Jade PTA Balloon Dilatation CatheterLIT2018-02-09
206761159646314K173894Jade PTA Balloon Dilatation CatheterLIT2018-02-09
206761209372585K173680Sapphire II PROLOX2018-03-01
2127281415000474K173680Sapphire II PROLOX2018-03-01
2127281153131866K163114Sapphire II PROLOX2017-01-05
206771735207482K163114Sapphire II PROLOX2017-01-05
206761735207482K163114Sapphire II PROLOX2017-01-05
2127281273801764K162209Sapphire NC PlusLOX2016-10-06
206771756066301K162209Sapphire NC PlusLOX2016-10-06
206761756066301K162209Sapphire NC PlusLOX2016-10-06
2127281797253375K103808SAPPHIRE NCLOX2011-09-01
206761910821440K103808SAPPHIRE NCLOX2011-09-01
206771910821440K103808SAPPHIRE NCLOX2011-09-01
206771627244227K103657SAPPHIRELOX2011-08-09
206761627244227K103657SAPPHIRELOX2011-08-09
2127281836407263K103657SAPPHIRELOX2011-08-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX222024-08-16
DQY52026-04-10
LIT52024-06-11
PNO22019-06-11
NWX 12021-12-21

PMA#

PMN#

GUDID#

80 records. Showing 1-40. Next