FDA.reportPublic FDA data

MEDTEC LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19327381000143606MEDTEC LLC1Y2026-01-011401 8TH ST. S.E. Orange City IA US 51041

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
176291612559066K982624MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242IYE1998-10-26
176291137027588K974703CARBON FIBER BREAST BOARDIYE1998-03-10
176291928956041K973842CARBON FIBER CONFORMAL COUCH TOPIXQ1997-12-05
176291835702475K952729PAINTED WEDGE & ROD BREAST BOARDIYE1995-09-15
176292012600127K951808MED-TEC REDI-FOAMIYE1995-07-06
176291518897728K951601MED-TEC STRING RETICLE TRAYIWE1995-05-11
176291687143849K950866HIP FIXATION SYSTEMIYE1995-05-30
176291746154514K950068CARBON FIBER COUCH INSERTKXJ1995-04-06
176291878113861K945515COATED TUNGSTEN EYESHIELDIWS1995-06-19
176291873570084K935412MED-TEC, INC. BREAST BOARD, MT-200IYE1994-07-18
176291251358885K935411MED-TEC, INC. BREAST BOARD, MT-250IYE1994-07-18
176291474504761K935300VAC-LOK IMMOBILIZATION SYSTEMIYE1994-07-18
176291228369369K933227UNI-FRAME HEAD IMMOBILIZATION SYSTEMIYE1994-07-18
176291386694145K211001C-Qual M™ Breastboard; Monarch™ Overhead Arm PositionerIYE2021-05-20
176291193948269K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic MaskIYE2018-09-07
176291050311580K180021Proton Positioing and Immobilization DevicesIYE2018-06-29
176291936050925K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge ReplacementIYE2016-05-25
176291567145440K132908TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KITIYE2014-03-04
176291473629053K132084PROTURA COUCH SOFTWAREJAI2013-09-26
176291577096073K122201PROTURA COUCH SOFTWAREJAI2012-08-30
176291175358546K121545BELLYBOARD, SBRT ACCESSORIESLNH2012-06-08
176291903727345K121284CHABNER XRT GARMENTSIYE2013-06-14
176291624491895K120916QFIX RADIOTHERAPY CHAIRJAI2012-06-20
176291879445393K111340HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEMLNH2011-06-28
176291896046164K102753TURBO TEMP 3EBG2011-02-04
176291850417681K093738MRI PATIENT POSITIONING DEVICESLNH2010-05-14
176291340847058K080072MRI PATIENT POSITIONING DEVICESIYE2008-06-04
176292049796049K071614FIDUCIAL MARKERSIYE2007-09-11
176291537938165K060737SINMED POSITIONING DEVICESIYE2006-03-31
176291995897580K034054PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100JAI2004-02-20
176291758531436K031866MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DACJAI2003-08-14
176291938207784K023293MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02IYE2002-12-23
176291566648991DEN220052BrachyGel Vaginal Hydrogel Packing SystemQXR2023-08-22
176291423491984DEN220017BioXmarkQUV2022-12-23
176291109244500
176291160143771
176291245049989
176291382838750
176291454569658
176291541824434
176291599986629
176291693898064
176291728183793
176291738476524
176291786271066
176291612748231
176291661235646
176291725465006
176291961600296
176292041658076

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE192021-05-20
JAI52013-09-26
LNH32012-06-08
QXR12023-08-22
QUV12022-12-23
EBG12011-02-04
IXQ11997-12-05
IWS11995-06-19
IWE11995-05-11
KXJ11995-04-06