Thomas Valentine

FDA Filings

This page includes the latest FDA filings for Thomas Valentine. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009894282
FEI Number3009894282
NameThomas Valentine
Owner & OperatorElekta Instrument AB
Contact AddressKungstensgatan 18 113 57 Stockholm Swede
Stockholm SE-AB Stockholms lan [SE-01] 10393 SE
Official Correspondent
  • Anders Skoglund
  • 46-85-8725428-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400 Perimeter Center Terrace, Suite 50
ATL, GA 30346 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number9710332
FEI Number3003251135
NameThomas Valentine
Owner & OperatorELEKTA AB
Contact AddressKUNGSTENSGATAN 18 Box 7593
STOCKHOLM SE-AB Stockholms lan [SE-01] SE10393 SE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400 Perimeter Center Terrace, Suite 50
ATL, GA 30346 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number9611894
FEI Number3002807741
NameThomas Valentine
Owner & OperatorNucletron B.V.
Contact Address3900 Ax Veenendaal, P.O. Box 930 Waardgelder 1
Veenendaal NL-UT Utrecht 3905 TH NL
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400 Perimeter Center Terrace, Suite 50
ATL, GA 30346 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Thomas Valentine [ELEKTA AB]
BodyFIX System2018-10-15
Thomas Valentine [Nucletron B.V.]
Leksell Vantage Stereotactic System2018-09-13
Thomas Valentine [Nucletron B.V.]
Leksell Stereotactic System2018-09-13
Thomas Valentine [Nucletron B.V.]
Advanced Gynecological Applicator2017-01-30
Thomas Valentine [Nucletron B.V.]
Henschke Titanium Applicator Set2015-06-24
Thomas Valentine [Nucletron B.V.]
Martinez Prostate Template Set2015-03-11
Thomas Valentine [Nucletron B.V.]
CT Markers Set2014-12-17
Thomas Valentine [Nucletron B.V.]
Luneray2014-07-01
Thomas Valentine [Nucletron B.V.]
Oncentra Brachy2014-06-20
Thomas Valentine [Nucletron B.V.]
FLETCHER CT/MR SHIELDED APPLICATOR SET2014-05-13
Thomas Valentine [Nucletron B.V.]
LumenCare Azure2014-02-25
Thomas Valentine [Nucletron B.V.]
Esteya2013-10-28
Thomas Valentine [Elekta Instrument AB]
Precise? Treatment Table2013-07-01
Thomas Valentine [Nucletron B.V.]
ProGuide Needle2012-12-17
Thomas Valentine [ELEKTA AB]
STEALTHSTATION PASSIVE INSTRUMENT OPTION2012-12-04
Thomas Valentine [ELEKTA AB]
INST 960-539 GUIDE, BIOPSY2012-12-04
Thomas Valentine [ELEKTA AB]
STEALTHSTATION SYSTEM UPDATE2012-12-04
Thomas Valentine [ELEKTA AB]
ARM 9734252 VERTEK II2012-12-04
Thomas Valentine [Nucletron B.V.]
check cable2012-07-13
Thomas Valentine [Nucletron B.V.]
Ir-192 Source2012-07-13
Thomas Valentine [Nucletron B.V.]
Smit Sleeve2012-07-13
Thomas Valentine [Nucletron B.V.]
Smit Sleeve CT/MR2012-07-13
Thomas Valentine [Nucletron B.V.]
VAGINAL CT/MR APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
STANDARD CT/MR APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
RING CT/MR APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
Fletcher CT/MR Applicator Set2012-07-06
Thomas Valentine [Nucletron B.V.]
Fletcher CT/MR Applicator Set XS2012-07-06
Thomas Valentine [Nucletron B.V.]
FLETCHER WILLIAMSON APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
FREIBURG FLAP APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
ROTTERDAM NASOPHARYNX MOULD SET2012-07-06
Thomas Valentine [Nucletron B.V.]
Prostate Stepper Template Set2012-07-06
Thomas Valentine [Nucletron B.V.]
Oncentra2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Masterplan2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra External Beam2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Brachy2012-07-05
Thomas Valentine [Nucletron B.V.]
Masterplan2012-07-05
Thomas Valentine [Nucletron B.V.]
OncoSelect Stepper2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Seeds2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Prostate2012-07-05
Thomas Valentine [Nucletron B.V.]
Laptop Cart2012-07-05
Thomas Valentine [Nucletron B.V.]
ERCM - EndoCavity Rotational Mover2012-07-05
Thomas Valentine [Nucletron B.V.]
Utrecht Interstitial Fletcher CT/MR Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Utrecht Interstitial CT/MR Applicator set2012-07-05
Thomas Valentine [Nucletron B.V.]
MR Line Marker2012-07-05
Thomas Valentine [Nucletron B.V.]
Interstitial Ring CT/MR Applicator set2012-07-05
Thomas Valentine [Nucletron B.V.]
Guiding Tube for Ring Set for Interstitial Ring2012-07-05
Thomas Valentine [Nucletron B.V.]
Guiding Tube for Ovoids2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Simulation2012-07-05
Thomas Valentine [Nucletron B.V.]
Vienna Ring CT/MR Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Trocar Point Titanium Needle Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Round Point Titanium Needle Set2012-07-05
Thomas Valentine [Nucletron B.V.]
TROCAR POINT TITANIUM NEEDLE SETS2012-07-05
Thomas Valentine [Nucletron B.V.]
ROUND POINT TITANIUM NEEDLE SETS2012-07-05
Thomas Valentine [Nucletron B.V.]
Valencia Skin Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Valencia Ft Skin Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL2012-07-05
Thomas Valentine [Nucletron B.V.]
IBU - Table2012-07-05
Thomas Valentine [Nucletron B.V.]
IBU - Digital2012-07-05
Thomas Valentine [Nucletron B.V.]
Simulix Evolution2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra ConeBeam2012-07-05
Thomas Valentine [Nucletron B.V.]
INTRACAVITARY MOULD APPLICATOR SET2012-07-05
Thomas Valentine [Nucletron B.V.]
INTRACAVITARY MOULD APPLICATOR SET Ft2012-07-05
Thomas Valentine [Nucletron B.V.]
OncoSmart Flange Molding Set2012-07-05
Thomas Valentine [Nucletron B.V.]
OncoSmart Catheter System2012-07-05
Thomas Valentine [Nucletron B.V.]
Flexible Implant Tube2012-07-05
Thomas Valentine [Nucletron B.V.]
CT/MR OncoSmart Catheter Sets2012-07-05
Thomas Valentine [Nucletron B.V.]
Kuske Breast Template Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Kuske Breast Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Breast CT/MR Template Set2012-07-05
Thomas Valentine [Nucletron B.V.]
selectSpacer2012-06-12
Thomas Valentine [Nucletron B.V.]
seedSelectron and accessories2012-06-12
Thomas Valentine [Nucletron B.V.]
disposable set2012-06-12
Thomas Valentine [ELEKTA AB]
Fraxion2012-05-18
Thomas Valentine [Nucletron B.V.]
Vaginal CT/MR Multi Channel Applicator Set2011-09-26
Thomas Valentine [Nucletron B.V.]
Catheter Set with Collar 6Fx293 mm2011-09-26
Thomas Valentine [Nucletron B.V.]
Vaginal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Trocar needles2011-06-28
Thomas Valentine [Nucletron B.V.]
Template Set, Breast Implants (complete)2011-06-28
Thomas Valentine [Nucletron B.V.]
Surface Mould Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Super Mould Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Standard Shielded Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Standard Nasopharyngeal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Speiser Needle Insertion System2011-06-28
Thomas Valentine [Nucletron B.V.]
Shielded Cylindrical Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Selectron Standard Shielded Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Selectron Standard Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Rowland Oesophageal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Rotte Endometrial Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Rotte Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Ring Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Porter Perineal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Pipard Tounge Template Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Pencil point needles2011-06-28
Thomas Valentine [Nucletron B.V.]
Pancreatic Flexible Needle Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Oesophageal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Novi Sad Inflatable Rectal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Norman Simon Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Nasopharyngeal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
NAG Brachyflex Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Miami Vaginal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Martinez Endometrial Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
MUPIT Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Lumencath Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Leipzig Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Ir-192 source2011-06-28
Thomas Valentine [Nucletron B.V.]
Interstitial Needle Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Interstitial Needle Basic Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Houdek Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Horiot Endometrial Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Henschke Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Fritz Adjustable Intralumenal Applicator2011-06-28
Thomas Valentine [Nucletron B.V.]
Fritz Adjustable Intralumenal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Fritz Adjustable Intralumenal Appl. Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Flexiguide Needle Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Flexible Implant Tube Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Demanes Rodriquez Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Catheter Insertion Set, 6F Trocar2011-06-28
Thomas Valentine [Nucletron B.V.]
Catheter Insertion Set, 6F Bevel2011-06-28
Thomas Valentine [Nucletron B.V.]
Catheter Deflection Set2011-06-28
Thomas Valentine [Nucletron B.V.]
CT/MR Applicator Clamp2011-06-28
Thomas Valentine [Nucletron B.V.]
Brain, Flexible Implant Needle Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Brain Needle Set with Fixing Tool2011-06-28
Thomas Valentine [Nucletron B.V.]
Bonvoisin-Gerard Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Bladder Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Bevel needles2011-06-28
Thomas Valentine [Nucletron B.V.]
Basic Rotte Endometrial Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Basic Norman Simon Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Arnhem Bile Duct Applicator2011-06-28
Thomas Valentine [Nucletron B.V.]
Martinez Prostate Template set2010-11-22
Thomas Valentine [Nucletron B.V.]
Cervix Ring Applicator set2010-11-22
Thomas Valentine [Nucletron B.V.]
Bonvoisin Gerard Esophageal Applicator Set2010-11-22
Thomas Valentine [Nucletron B.V.]
X-ray markers2010-11-17
Thomas Valentine [Nucletron B.V.]
Vaginal Cylinder applicator2010-11-17
Thomas Valentine [Nucletron B.V.]
Transfer Tubes2010-11-17
Thomas Valentine [Nucletron B.V.]
Ti vaginal Cylinder applicator set2010-11-17
Thomas Valentine [Nucletron B.V.]
Source Position Check Ruler (SPCR)2010-11-17
Thomas Valentine [Nucletron B.V.]
Flexitron2010-11-17
Thomas Valentine [Nucletron B.V.]
Flexisource and Check Cable2010-11-17
Thomas Valentine [Nucletron B.V.]
Cervix Rotterdam Applicators2010-11-17
Thomas Valentine [Nucletron B.V.]
Bronchial Catheter Adapter2010-11-17
Thomas Valentine [Nucletron B.V.]
microSelectron V32008-10-16
Thomas Valentine [Nucletron B.V.]
microSelectron PDR2008-10-16
Thomas Valentine [Nucletron B.V.]
microSelectron HDR2008-10-16
Thomas Valentine [Nucletron B.V.]
microSelectron Digital2008-10-16
Thomas Valentine [Nucletron B.V.]
OncoSelect PDR2008-10-16
Thomas Valentine [Nucletron B.V.]
OncoSelect HDR2008-10-16
Thomas Valentine [ELEKTA AB]
HEXAPOD COUCH TOP2006-10-25
Thomas Valentine [Nucletron B.V.]
selectSeed I-1252006-09-06
Thomas Valentine [ELEKTA AB]
ATLAS INTERVENTION2005-10-17
Thomas Valentine [ELEKTA AB]
iBEAM, various2004-10-14
Thomas Valentine [ELEKTA AB]
Unity CT Overlay2004-10-14
Thomas Valentine [ELEKTA AB]
Elekta Unity CT Overlay2004-10-14
Thomas Valentine [ELEKTA AB]
Connexion, various2004-10-14
Thomas Valentine [ELEKTA AB]
TARGET POSITIONER UNIT2001-05-15
Thomas Valentine [ELEKTA AB]
HEADFIX AND LOCALIZER2001-05-15

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