FDA.reportPublic FDA data

MEDTRONIC B.V. (EOC)

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028075613002807561MEDTRONIC B.V. (EOC)1N2026-01-01EARL BAKKENSTRAAT 10 HEERLEN Limburg NL 6422 PJ

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58051122921662P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY1993-12-09
58051016057609P140018VENASEAL CLOSURE SYSTEMPJQ2015-02-20
58051289344868K982532PARIETEXFTL1999-01-20
58051907206253K962173SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESJOH1996-10-04
58051178625849K912240CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEMBYE1991-08-22
58051823799901K873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)BTR1987-11-06
58051716670046K862666UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)BTR1986-08-01
58051913305087K790575TUBE, ARMORED TRACHEALBTR1979-04-13
58051946966373K771219BRONCHO-CATHBTS1977-08-04
58051099376353K163212Parietene DS Composite MeshFTL2017-06-29
58051064677602K162892Achieve Advance Mapping CatheterDRF2016-11-15
58051133635057K153139Achieve ST Mapping Catheter, Catheter Connecting CableDRF2016-05-06
58051658609574K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner CannulaJOH2015-07-14
58051655976362K150091Versatex Monofilament MeshFTL2015-05-26
58051744279080K143386Progrip Laparoscopic Self-Fixating MeshFTL2015-03-13
58051380559645K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating MeshFTL2014-10-28
58051989074525K142091PARIETENE MACROPOROUS MESHFTL2014-10-17
58051098843720K131969SYMBOTEX(TM) COMPOSITE MESHFTL2013-08-22
58051516390472K120605PERMACOL SURGICAL IMPLANTFTM2012-05-18
58051420980024K110957M4 MONITORDRY2011-05-31
58051494500234K091813INTREPID SPINAL SYSTEMOVD2009-11-17
58051436332069K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESBTR2008-10-02
58051852515669K073291CAPSTONE SPINAL SYSTEMMAX2008-04-24
58051545083959K052747MODIFICATION TO:CD HORIZON SPINAL SYSTEMNKB2005-10-28
58051636858941K051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULAJOH2005-06-16
58051286923865
58051644538247

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FTL72017-06-29
BTR42008-10-02
JOH32015-07-14
DRF22016-11-15
PJQ12015-02-20
FTM12012-05-18
DRY12011-05-31
OVD12009-11-17
MAX12008-04-24
NKB12005-10-28
NVY11993-12-09
BYE11991-08-22
BTS11977-08-04