FDA.reportPublic FDA data

BARD SHANNON LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056365443005636544BARD SHANNON LIMITED1N2026-01-01San Geronimo Industrial Park Km. 76.7 Lot #1 Road #3 Bo. Rio Abajo Humacao PR US 00791

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
361051395807547K953577BARD VISILEX MESH 3 X 6FTL1995-09-26
361051633967069K922916BARD MARLEX MESH DARTFTL1992-08-24
361051529270858K915841BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPICKNT1993-06-25
361051043927615K860432PERCUTANEOUS INTRODUCER KITDYB1986-03-31
361051205175991K830406NON-STERILE CATHETER REPAIR KITSLJS1983-03-01
361051125162429K171953Bard Mission Disposable Core Biopsy InstrumentKNW2017-09-14
361051451532857K143380Phasix ST MeshOWT2015-06-05
361051870097065K142818Phasix MeshOOD2015-03-31
361051305604715K142808CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fastenersGDW2015-03-09
361051388394431K133948BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENTKNW2014-02-21
361051389078595K122436COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEMFTL2012-11-02
361051630221286K103109PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBEKNT2010-12-22
361051071348469K092607AJUST ADJUSTABLE SINGLE INCISION SLINGPAH2009-11-20
361051148094231K091659BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732FTL2009-08-03
361051461600091K083839AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEMOTP2009-01-15
361051429722011K082571AVAULTA SUPPORT SYSTEMOTP2008-09-30
361051467779788K081272PORCINE SURGICAL MESH; DERMAL MATRIXFTM2008-07-31
361051769198429K081010BARD 3DMAX MESHFTL2008-10-07
361051325934237K063712AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEMOTP2007-03-12
361051207275390K052155BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPEDFTL2005-10-20
361051140231836K042026BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004FTL2004-09-10
361051227200643K041641DAVOL DELIVERY SYSTEMGCJ2004-07-01
361051875035693K022350BARD CRURASOFT PATCH, MODELS 0116003 & 0116001FTL2002-08-23
361051347117541K002684COMPOSIX E/X MESHFTL2000-10-11
361051205761221
361051306900747
361051518164645
361051700369043
361051008564765
361051037138987
361051081439100
361051081840160
361051172894015
361051189012553
361051204923851
361051208161874
361051222623587
361051234366676
361051246545340
361051252258738
361051267348653
361051282431785
361051305599672
361051339592358
361051350800957
361051371101384
361051401492422
361051405464196
361051438642181
361051453849783
361051461381332
361051476572322
361051515449469
361051530419612
361051550026144
361051562878235
361051563529954
361051599353124
361051633967069
361051634879936
361051718671558
361051729549758
361051734000236
361051777884253
361051800074813
361051810473647
361051812637610
361051827079434
361051831106899
361051831544907
361051837618884
361051844229215
361051869109950
361051881070827
361051886923577
361051893984755
361051931988259
361051933310477
361051981754070
361051994827074
361052005993443
361052024220708
361052045600072
361052048629884
361052066322745

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FTL92012-11-02
OTP32009-01-15
KNW22017-09-14
KNT22010-12-22
OWT12015-06-05
OOD12015-03-31
GDW12015-03-09
PAH12009-11-20
FTM12008-07-31
GCJ12004-07-01
DYB11986-03-31
LJS11983-03-01