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Data / Medical devices / Netherlands / Medtronic B.V. (eoc)

Medtronic B.V. (eoc): FDA-registered device maker in HEERLEN Limburg, Netherlands, 21 510(k) clearances and 2 PMA approvals

Medtronic B.V. (eoc) is registered with the FDA (registration 3002807561) in HEERLEN Limburg, Netherlands. It lists 22 device types. The FDA files 21 510(k) clearances and 2 PMA approvals under its listings, the newest dated June 29, 2017. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Medtronic B.V. (eoc)
FDA registration number
3002807561
Address
Earl Bakkenstraat 10, HEERLEN Limburg, Netherlands, 6422 PJ
Owner or operator
Medtronic, Inc. (2112641)
Roles
Exporter to the US
First device listed
December 12, 1992
Registered through
2026
Brand names listed
Adaptor Extender Kit, Adaptor Kit, BronchoCath with CPAP, CAPSTONE Spinal System, CD HORIZON® Spinal System, CD Perc Trauma, CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM, DF-1 Port Pin Plug and more

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Occluding, Vascular, PermanentPJQ3Exporter to the USaccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Exporter to the USaccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Exporter to the USaccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Exporter to the USaccessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)LWS3Exporter to the USaccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Exporter to the USaccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Exporter to the USaccessdata.fda.gov
Mesh, SurgicalFTM2Exporter to the USaccessdata.fda.gov
Mesh, Surgical, Collagen, Large Abdominal Wall DefectsOXK2Exporter to the USaccessdata.fda.gov
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall DefectsOXJ2Exporter to the USaccessdata.fda.gov
Mesh, Surgical, PolymericFTL2Exporter to the USaccessdata.fda.gov
Monitor, Blood-Gas, On-Line, Cardiopulmonary BypassDRY2Exporter to the USaccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Exporter to the USaccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Exporter to the USaccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Exporter to the USaccessdata.fda.gov
Permanent Defibrillator ElectrodesNVY3Exporter to the USaccessdata.fda.gov
Posterior Metal/Polymer Spinal System, FusionNQP2Exporter to the USaccessdata.fda.gov
ScrewdriverHXX1Exporter to the USaccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Exporter to the USaccessdata.fda.gov
Tube Tracheostomy And Tube CuffJOH2Exporter to the USaccessdata.fda.gov
Tube, Bronchial (W/Wo Connector)BTS2Exporter to the USaccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 29, 2017K163212Parietene DS Composite MeshFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
July 14, 2015K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner CannulaJOHSubstantially EquivalentCovidienaccessdata.fda.gov
May 26, 2015K150091Versatex Monofilament MeshFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
March 13, 2015K143386Progrip Laparoscopic Self-Fixating MeshFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
October 28, 2014K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating MeshFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
October 17, 2014K142091PARIETENE MACROPOROUS MESHFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
August 22, 2013K131969SYMBOTEX(TM) COMPOSITE MESHFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
May 18, 2012K120605PERMACOL SURGICAL IMPLANTFTMSubstantially EquivalentCovidien, LLCaccessdata.fda.gov
May 31, 2011K110957M4 MONITORDRYSubstantially EquivalentSpectrum Medical, Llpaccessdata.fda.gov
November 17, 2009K091813INTREPID SPINAL SYSTEMOVDSubstantially EquivalentMedtronic Sofamor Danekaccessdata.fda.gov
October 2, 2008K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESBTRSubstantially EquivalentMallinckrodt Medicalaccessdata.fda.gov
April 24, 2008K073291CAPSTONE SPINAL SYSTEMMAXSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
October 28, 2005K052747MODIFICATION TO:CD HORIZON SPINAL SYSTEMNKBSubstantially EquivalentMedtronic Sofamor Danekaccessdata.fda.gov
June 16, 2005K051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULAJOHSubstantially EquivalentMallinckrodt Medicalaccessdata.fda.gov
January 20, 1999K982532PARIETEXFTLSubstantially EquivalentCogentaccessdata.fda.gov
October 4, 1996K962173SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESJOHSubstantially EquivalentMallinckrodt Medicalaccessdata.fda.gov
August 22, 1991K912240CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEMBYESubstantially EquivalentMallinckrodt Anesthesia Productsaccessdata.fda.gov
November 6, 1987K873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)BTRSubstantially EquivalentMallinckrodt Critical Careaccessdata.fda.gov
August 1, 1986K862666UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)BTRSubstantially EquivalentMallinckrodt Critical Careaccessdata.fda.gov
April 13, 1979K790575TUBE, ARMORED TRACHEALBTRSubstantially EquivalentNational Patent Development Corp.accessdata.fda.gov
August 4, 1977K771219BRONCHO-CATHBTSSubstantially EquivalentMallinckrodt Critical Careaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 20, 2015P140018VENASEAL CLOSURE SYSTEMPJQ47October 15, 2026accessdata.fda.gov
December 9, 1993P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY294August 19, 2026accessdata.fda.gov

Compare with other makers

Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.