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Freudenberg Medical Ireland Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30083286903008328690Freudenberg Medical Ireland Limited1N2026-01-01IDA Business & Technology Park, Carrick On Shannon, CO, Leitrim Leitrim IE N41 N8C9

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1151671656306511K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar CageMAX2019-07-25
1151671796366497K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-12-21
1151671631268028K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-01-25
1151671631654731K130430IVAS 10MM AND 15MM BALLOON CATHETERHRX2013-05-23
1151672012434995K123942STRYKER IVAS BALLOON CATHETERNDN2013-04-03
1151671162422785K111031PAINFUSOR CATHETERBSO2011-07-08
1151671318066940K093419IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVASNDN2010-03-18
1151671379370262K031617MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETERKLA2004-01-16
1151671063138587K013704MEDIPLUS SINGLE USE GI MANOMETRY CATHETERKLA2002-08-05
1151671417300071K013536EMTRAC; DELPHIN; SEMTRAC 2000 SETMQF2001-11-30
1151671585907538
1151671240538556
1151671606870038
1151671798521708
1151671806150214

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRX32018-12-21
NDN22013-04-03
KLA22004-01-16
MAX12019-07-25
BSO12011-07-08
MQF12001-11-30