Medtec Inc

FDA Filings

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

FDA Registration(s)
Registration Number1932738
FEI Number1000143606
NameMEDTEC, Inc.
Owner & OperatorMEDTEC
Contact Address1401 8TH ST., S.E. --
Orange City IA 51041 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1401 8TH ST. S.E.
Orange City, IA 51041 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
MEDTEC, INC.
 Pronumbra RT-C892K2025-09-22
MEDTEC, INC.
 Pronumbra RT-C889K2025-09-22
MEDTEC, INC.
 Pronumbra RT-C878K2025-09-22
MEDTEC, INC.
 Pronumbra RT-C876K2025-09-22
MEDTEC, INC.
 Pronumbra RT-4536KV-2002025-09-22
MEDTEC, INC.
 Pronumbra RT-4536-1002025-09-22
MEDTEC, INC.
 Encompass™ RT-B889KYSH-12025-09-22
MEDTEC, INC.
 Encompass™ RT-B889KYSH2025-09-22
MEDTEC, INC.
 ONEFit RT-4800-C02025-09-22
MEDTEC, INC.
 Pronumbra RT-4536-012025-09-22
MEDTEC, INC.
 Pronumbra RT-4536KV-022025-09-22
MEDTEC, INC.
 ZiFix Traverse RT-4558CB042025-09-22
MEDTEC, INC.
 Pronumbra RT-4536-SA012025-09-22
MEDTEC, INC.
 Pronumbra RT-4536-NS652025-09-22
MEDTEC, INC.
 Pronumbra RT-4536-NS502025-09-22
MEDTEC, INC.
 Pronumbra RT-4536-NS402025-09-22
MEDTEC, INC.
 Pronumbra RT-4536KV-012025-09-22
MEDTEC, INC.
 Pronumbra RT-4536-HH01R2025-09-22
MEDTEC, INC.
 Pronumbra RT-4536-HH01L2025-09-22
MEDTEC, INC.
 BioXmark 2025-07-09
MEDTEC, INC.
 Adjustable Backrest MTIL71162025-05-01
MEDTEC, INC.
 Adjustable Backrest MTIL71152025-05-01
MEDTEC, INC.
 Posi Indexing Bar MTWBL0062025-01-10
MEDTEC, INC.
 Headrest - Timo size F with base MTTIMO2FBB2024-12-12
MEDTEC, INC.
 Headrest - Timo size B with base MTTIMO2BBB2024-12-12
MEDTEC, INC.
 Headrest - Timo size F with base MTTIMO2FL2024-12-12
MEDTEC, INC.
 Headrest - Timo size C with base MTTIMO2CL2024-12-12
MEDTEC, INC.
 Headrest - Timo size B with base MTTIMO2BL2024-12-12
MEDTEC, INC.
 Headrest - Timo size A with base MTTIMO2AL2024-12-12
MEDTEC, INC.
 Headrest - TIMO Size A, B, C, F MTTIMO2L2024-12-12
MEDTEC, INC.
 Headrest - Timo Size F MTTIMO2F2024-12-12
MEDTEC, INC.
 Headrest - Timo size E MTTIMO2E2024-12-12
MEDTEC, INC.
 Headrest - Timo size D MTTIMO2D2024-12-12
MEDTEC, INC.
 Headrest - Timo size C MTTIMO2C2024-12-12
MEDTEC, INC.
 Headrest - Timo size B MTTIMO2B2024-12-12
MEDTEC, INC.
 Headrest - Timo Size A MTTIMO2A2024-12-12
MEDTEC, INC.
 Headrest - TIMO Size A, B, C, D, E, F MTTIMO22024-12-12
MEDTEC, INC.
 Universal Couchtop™ MTIL67422024-10-28
MEDTEC, INC.
 Rectangular Extension MTIL66862024-10-09
MEDTEC, INC.
 GE MR Posifix® Baseplate 1010272024-10-09
MEDTEC, INC.
 Wedge and Spacer Set 107106MR2024-07-17
MEDTEC, INC.
 Spacer 107104MR2024-07-17
MEDTEC, INC.
 Spacer 107103MR2024-07-17
MEDTEC, INC.
 Wedge 107102MR2024-07-17
MEDTEC, INC.
 BrachyGel Vaginal Hydrogel Packing System RT-53002024-05-31
MEDTEC, INC.
 Pro Posifix® Headrest Adapter OAP1212024-05-24
MEDTEC, INC.
 ProForm™ Thermoplastic PRO3391832SGN2024-02-20
MEDTEC, INC.
 ProForm™ Thermoplastic PRO339IM1832CLN2024-02-20
MEDTEC, INC.
 ProForm™ Thermoplastic PRO339IM1832S2024-02-20
MEDTEC, INC.
 ProForm™ Thermoplastic PRO339IM1832N2024-02-20
MEDTEC, INC.
 ProForm™ Thermoplastic PRO339IM1832CL2024-02-20
MEDTEC, INC.
 ProForm™ Thermoplastic PRO339IM18322024-02-20
MEDTEC, INC.
 Molded Hand Grip OAP1402024-02-20
MEDTEC, INC.
 Mevion Rectangular Backrest MTIL71112024-02-12
MEDTEC, INC.
 Universal Couchtop™ MTIL6048152024-01-30
MEDTEC, INC.
 Universal Couchtop™ MTIL6047152024-01-30
MEDTEC, INC.
 Canon RGSC Adapter Plate MTIL3704102024-01-30
MEDTEC, INC.
 Evolve Type-S™ Locating Bar OAP2262023-07-04
MEDTEC, INC.
 Slide Guide 3-Pin Lok-Bar™ MTIL60582023-07-04
MEDTEC, INC.
 Positioning Cushion 3012022023-06-19
MEDTEC, INC.
 Positioning Cushion 3012032023-06-19
MEDTEC, INC.
 Positioning Cushion 3012042023-06-19
MEDTEC, INC.
 Positioning Cushion 3012052023-06-19
MEDTEC, INC.
 Rectangular Backrest MTIL71102023-06-19
MEDTEC, INC.
 Thorawedge™ Locator TWI1002023-05-26
MEDTEC, INC.
 AccuForm™ Cushion MTACL5865T2023-03-20
MEDTEC, INC.
 AccuForm™ Cushion MTACL2035U2023-03-20
MEDTEC, INC.
 AccuForm™ Cushion MTACLTYPES22023-03-20
MEDTEC, INC.
 AccuForm™ Cushion MTACLTYPESN2023-03-20
MEDTEC, INC.
 ThermFix Spacing Tool MTWBL0052023-03-13
MEDTEC, INC.
 ThermFix Pelvic Inferior Bar MTWBL0042023-03-13
MEDTEC, INC.
 ThermFix Inferior Bar MTWBL0032023-03-13
MEDTEC, INC.
 ThermFix Superior Bar MTWBL0022023-03-13
MEDTEC, INC.
 Universal Couchtop™ MTIL6049152023-02-27
MEDTEC, INC.
 Interface Plate MTIL6029122023-02-27
MEDTEC, INC.
 Universal Couchtop™ MTIL60492023-02-27
MEDTEC, INC.
 Universal Couchtop™ MTIL60292023-02-27
MEDTEC, INC.
 UCT Proton Extension (1349mm) MTIL66842023-02-13
MEDTEC, INC.
 Positioning Cushion 3012012022-11-23
MEDTEC, INC.
 Universal Couchtop™ MRI Overlay - GE MTM33052022-11-14
MEDTEC, INC.
 Universal Couchtop™ MRI Overlay - GE MTM33042022-11-14
MEDTEC, INC.
 Universal Couchtop™ MRI Overlay - GE GEM MTM33032022-11-14
MEDTEC, INC.
 ProForm™ Head and Neck Extension MTIL66832022-10-24
MEDTEC, INC.
 ProForm™ Head and Neck Extension MTIL66812022-10-24
MEDTEC, INC.
 ProForm™ Head and Neck Extension MTIL66802022-10-24
MEDTEC, INC.
 ProForm™ Head and Neck Extension MTIL66792022-10-24
MEDTEC, INC.
 ProForm™ Head and Neck Extension MTIL66782022-10-24
MEDTEC, INC.
 Evolve Slant Board OAP2002022-10-24
MEDTEC, INC.
 Evolve Bottom Board OAP2102022-10-24
MEDTEC, INC.
 Pro Handle OAP2212022-10-24
MEDTEC, INC.
 Pro Wing Board™ OAP2202022-10-24
MEDTEC, INC.
 ProForm™ Pediatric Thermoplastic PRO430IM1832SG2022-08-29
MEDTEC, INC.
 ProForm™ Pediatric Thermoplastic PRO430IM1832CL2022-08-29
MEDTEC, INC.
 ProForm™ Pediatric Thermoplastic PRO430IM18322022-08-29
MEDTEC, INC.
 ProForm™ Pediatric Thermoplastic PRO4302022-08-29
MEDTEC, INC.
 ProForm™ Pediatric MR Overlay PRO4202022-08-29
MEDTEC, INC.
 ProForm™ Pediatric Overlay PRO4002022-08-29
MEDTEC, INC.
 ProForm™ Pediatric Head and Neck Extension MTIL66822022-08-29
MEDTEC, INC.
 Prodigy™ 2 Lok-Bar™ MTIL60572022-08-29
MEDTEC, INC.
 Prodigy™ 2 Lok-Bar™ MTIL60562022-08-29
MEDTEC, Inc. Dba CIVCO Medical Solutions And CIVCO
C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner2021-05-20
MEDTEC, Inc. [MEDTEC]
Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask2018-09-10
MEDTEC, Inc. [MEDTEC]
Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask2018-09-10
MEDTEC Inc. Dba CIVCO Medical Solutions
Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask2018-09-07
MEDTEC, Inc. [MEDTEC]
Proton Positioning and Immobilization Solutions2018-07-05
MEDTEC, Inc. [MEDTEC]
Proton Positioning and Immobilization Solutions2018-07-05
MEDTEC, Inc. [MEDTEC]
Proton Positioning and Immobilization Solutions2018-07-05
MEDTEC, Inc. D/b/a "CIVCO Medical Solutions" And "CIVCO Radi
Proton Positioing And Immobilization Devices2018-06-29
MEDTEC, Inc. [MEDTEC]
Chabner XRT Garments2017-11-03
MEDTEC, Inc. [MEDTEC]
Body Pro-Lok Respiratory Plate with Cushion, Body Pro-Lok Respiratory Belt2016-11-28
MEDTEC, Inc. [MEDTEC]
Body Pro-Lok Respiratory Plate with Cushion, Body Pro-Lok Respiratory Belt2016-11-28
MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp For Respiratory Belt, Pressure Gauge Replacement2016-05-25
MEDTEC, Inc. [MEDTEC]
Shoulder Retractor; Wrist Straps2015-08-27
MEDTEC, Inc. [MEDTEC]
trUpoint Arch2015-08-26
MEDTEC, Inc. [MEDTEC]
Protura Software2015-08-26
MEDTEC, INC.
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT2014-03-04
MEDTEC, Inc. [MEDTEC]
Carbon Fiber Conformal Couch Top2013-12-17
MEDTEC, Inc. [MEDTEC]
MEDTEC String Reticle Tray2013-12-17
MEDTEC, Inc. [MEDTEC]
Coated Tungsten Eyeshield2013-12-17
MEDTEC, Inc. [MEDTEC]
Protura Couch Software 1.3.02013-12-17
MEDTEC, Inc. [MEDTEC]
SBRT Accessories2013-12-17
MEDTEC, Inc. [MEDTEC]
Bellyboard2013-12-17
MEDTEC, Inc. [MEDTEC]
SBRT Accessories2013-12-17
MEDTEC, Inc. [MEDTEC]
Bellyboard2013-12-17
MEDTEC, Inc. [MEDTEC]
MR & Radiological Patient Positioning Devices2013-12-17
MEDTEC, Inc. [MEDTEC]
MR & Radiological Patient Positioning Devices2013-12-17
MEDTEC, Inc. [MEDTEC]
MRI Patient Positioning Devices2013-12-17
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
BELLYBOARD, SBRT ACCESSORIES2012-06-08
MEDTEC, INC.
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM2011-06-28
MEDTEC, Inc. [MEDTEC]
Painted Wedge & Rod Breast Board2010-12-28
MEDTEC, Inc. [MEDTEC]
Breast Board2010-12-28
MEDTEC, Inc. [MEDTEC]
Breast Board2010-12-28
MEDTEC, INC.
MRI PATIENT POSITIONING DEVICES2010-05-14
MEDTEC, Inc. [MEDTEC]
Protura Software2009-12-28
MEDTEC, Inc. [MEDTEC]
Protura2009-12-28
MEDTEC, Inc. [MEDTEC]
Redi Foam2009-09-09
MEDTEC, Inc. [MEDTEC]
Hipfix2009-09-09
MEDTEC, Inc. [MEDTEC]
Hip & Pelvic fixation system2009-09-09
MEDTEC, Inc. [MEDTEC]
Posifix pediatric2009-09-09
MEDTEC, Inc. [MEDTEC]
Posifix head inclination system2009-09-09
MEDTEC, Inc. [MEDTEC]
Posifix Head & Neck2009-09-09
MEDTEC, Inc. [MEDTEC]
Bellyboard2009-09-09
MEDTEC, Inc. [MEDTEC]
Vac-Loc cushions2009-02-26
MEDTEC, Inc. [MEDTEC]
MRI Vac-Loc Cushions2009-02-26
MEDTEC, Inc. [MEDTEC]
MRI Uniframe Baseplate2009-02-26
MEDTEC, Inc. [MEDTEC]
MRI Thermoplastic2009-02-26
MEDTEC, Inc. [MEDTEC]
MRI Redifoam2009-02-26
MEDTEC, Inc. [MEDTEC]
MRI Loc-bar2009-02-26
MEDTEC, Inc. [MEDTEC]
MRI Headrest2009-02-26
MEDTEC, Inc. [MEDTEC]
MRI Accuform Cushions2009-02-26
MEDTEC, Inc. [MEDTEC]
Fiducial Markers2009-02-26
MEDTEC, Inc. [MEDTEC]
AccuForm Cushion2008-06-23
MEDTEC, Inc. [MEDTEC]
Type-S Extension2008-06-23
MEDTEC, Inc. [MEDTEC]
Breast Board & Accessories2008-06-13
MEDTEC, Inc. [MEDTEC]
carbon fiber couch insert2008-05-15
MEDTEC, Inc. [MEDTEC]
MEDTEC ACCESSORIES2005-10-27
MEDTEC, Inc. [MEDTEC]
MEDTEC SHIELDING ALLOY2005-06-28
MEDTEC, Inc. [MEDTEC]
MEDTEC FLAT-FOAM2005-06-28
MEDTEC, Inc. [MEDTEC]
MED-TEC THERMOPLASTIC SHIELD2005-06-28
MEDTEC, Inc. [MEDTEC]
MED-TEC POSITIONING AIDS2002-12-11
MEDTEC, Inc. [MEDTEC]
MED-TEC TABLE TOP (C2001-08-24
MEDTEC, Inc. [MEDTEC]
MED-TEC BRACHYTHERAPY LOADER2001-08-24
MEDTEC, Inc. [MEDTEC]
HOLDER2001-08-24
MEDTEC, Inc. [MEDTEC]
MED-TEC WATER BATH2001-05-11
MEDTEC, Inc. [MEDTEC]
MED-TEC ALLOY MELTER2001-05-11
MEDTEC, Inc. [MEDTEC]
TG-51)1999-10-15
MEDTEC, Inc. [MEDTEC]
SEQUEL1999-10-15
MEDTEC, Inc. [MEDTEC]
MED-TEC PHANTOMS (DISCOVERY1999-10-15
MEDTEC, Inc. [MEDTEC]
,1999-10-15
MEDTEC, INC.
CARBON FIBER BREAST BOARD1998-03-10
MEDTEC, INC.
MATRIX MT-MX31998-03-04
MEDTEC, INC.
CARBON FIBER CONFORMAL COUCH TOP1997-12-05
MEDTEC, INC.
INTRA-ORAL THERMOPLASTIC SHIELD1996-10-01
MEDTEC, INC.
GREEN TEC-21001996-05-24
MEDTEC, INC.
ACRYSTEEL BLOCKING TRAY1996-01-05
MEDTEC, INC.
THERMOPLASTIC SHIELD1995-12-21
MEDTEC, INC.
MED-TEC HAND GRIP1995-11-14
MEDTEC, INC.
MEDTEC AUTOBLOT 20001995-10-17
MEDTEC, INC.
PAINTED WEDGE & ROD BREAST BOARD1995-09-15
MEDTEC, INC.
TEC-2110 GREEN LASER MODEL MT-HNG1995-08-18
MEDTEC, INC.
MED-TEC REDISET1995-08-09
MEDTEC, INC.
MED-TEC TRAY ADAPTER1995-07-13
MEDTEC, INC.
MED-TEC RADIO THERAPY TREATMENT CHAIR1995-07-12
MEDTEC, INC.
MED-TEC TESTICULAR SEPARATOR1995-07-12
MEDTEC, INC.
MED-TEC REDI-FOAM1995-07-06
MEDTEC, INC.
MED-TEC KNEE CRUTCH1995-06-28
MEDTEC, INC.
COATED TUNGSTEN EYESHIELD1995-06-19
MEDTEC, INC.
HIP FIXATION SYSTEM1995-05-30
MEDTEC, INC.
MED-TEC STRING RETICLE TRAY1995-05-11
MEDTEC, INC.
CARBON FIBER COUCH INSERT1995-04-06
MEDTEC, Inc. [MEDTEC]
MED-TEC DUAL LEG POSITIONER1995-01-30
MEDTEC, INC.
FIELD ABUTMENT WEDGE1994-12-23
MEDTEC, INC.
TUNGSTEN EYESHIELD1994-12-23
MEDTEC, INC.
HP BACK POINTER SYSTEM1994-12-07
MEDTEC, INC.
MOTORIZED DEPTH DOSE APPARATUS1994-12-07
MEDTEC, INC.
BLOCKING TRAY1994-11-22
MEDTEC, INC.
MT-300 CASSETTE HOLDER1994-09-16
MEDTEC, INC.
MED-TEC BREAST SUPPORT SYSTEM1994-07-18
MEDTEC, INC.
360 DEG. ROTATING 1/2 BEAM BLOCK1994-07-18
MEDTEC, INC.
TEC 2101 (MODEL MT-HPLGD)1994-07-18
MEDTEC, INC.
MED-TEC, INC. BREAST BOARD, MT-2001994-07-18
MEDTEC, INC.
MED-TEC, INC. BREAST BOARD, MT-2501994-07-18
MEDTEC, INC.
VAC-LOK IMMOBILIZATION SYSTEM1994-07-18
MEDTEC, INC.
UNI-FRAME HEAD IMMOBILIZATION SYSTEM1994-07-18
MEDTEC, Inc. [MEDTEC]
55 CM BODY CALIPER1994-07-12
MEDTEC, Inc. [MEDTEC]
GRID TRAY1994-07-12
MEDTEC, Inc. [MEDTEC]
MED-TEC COATED TUNGSTEN EYESHIELD1994-07-12
MEDTEC, Inc. [MEDTEC]
QA TOOL1994-06-03
MEDTEC, Inc. [MEDTEC]
MED-TEC LASER POSITIONER1994-06-03
MEDTEC, INC.
HANDI-FOAM1994-04-07
MEDTEC, Inc. [MEDTEC]
MED-TEC SHOULDER SUPPRESSION SYSTEM1994-01-28
MEDTEC, Inc. [MEDTEC]
MED-TEC GREEN STRATUS L1994-01-28
MEDTEC, INC.
TEC 2100 (MODEL MT-LPLGD)1994-01-25
MEDTEC, INC.
INSTA-FLO1993-12-13
MEDTEC, INC.
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM1993-12-13

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Related Finance Registrations
NCAGE Code0U9D0MEDTEC, INC.!DBA CIVCO MEDICAL SOLUTIONS!DIV CIVCO RADIOTHERAY
CAGE Code0U9D0MEDTEC, INC. CIVCO MEDICAL SOLUTIONS CIVCO RADIOTHERAY
S.A.M. Registration0U9D0 [103977526]MEDTEC, INC. CIVCO MEDICAL SOLUTIONS
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
201905083070Stadersand,Federal Republic of Germany -> Norfolk, VirginiaSTANDARD WING BOARD TIMO HEADREST GE CT OVERL AY LOADED ON 3 PACKAGES28 PCS
2019042511647Stadersand,Federal Republic of Germany -> Norfolk, VirginiaSTANDARD WING BOARD TIMO HEADREST GE CT OVERL AY LOADED ON 3 PACKAGES28 PCS
2019042413985Stadersand,Federal Republic of Germany -> Norfolk, VirginiaSTANDARD WING BOARD TIMO HEADREST GE CT OVERL AY LOADED ON 3 PACKAGES28 PCS
2019041824164Stadersand,Federal Republic of Germany -> Norfolk, VirginiaSTANDARD WING BOARD TIMO HEADREST GE CT OVERL AY LOADED ON 3 PACKAGES28 PCS
2019041037636Stadersand,Federal Republic of Germany -> Norfolk, VirginiaSTANDARD WING BOARD TIMO HEADREST GE CT OVERL AY LOADED ON 3 PACKAGES28 PCS
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