TheraTears Lubricant
carboxymethylcellulose sodium
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1483278 | 1483278 | MEDTEC APPLICATIONS, INC. | 1 | Y | 2026-01-01 | 35 N Brandon Dr Glendale Heights IL US 60139 |
| 1719513 | 1719513 | MEDTECH PRODUCTS, INC. | 1 | Y | 2026-01-01 | 660 white plains rd Tarrytown NY US 10591 |
| 1932738 | 1000143606 | MEDTEC LLC | 1 | Y | 2026-01-01 | 1401 8TH ST. S.E. Orange City IA US 51041 |
| 3009131011 | 3009131011 | MEDTECH ACUNA S.A. DE C.V. | 1 | N | 2026-01-01 | Juarez No. 200 Altos, B Acuna Coahuila MX 26200 |
| 3010123256 | 3010123256 | MEDTECH LLC | 1 | N | 2026-01-01 | 8022 Martha Rd Millington TN US 38053 |
| 3012344767 | 3012344767 | MEDTECS (CAMBODIA) CORP. LIMITED | 1 | N | 2026-01-01 | National road number 7, Phum Ampil Leu, Khum Ampil Srok Kampong Siem Kampong Cham KH 030501 |
| 3017734066 | 3017734066 | Medtecs USA Corporation | 1 | Y | 2026-01-01 | 2082 Business Center Dr, Ste 175, Irvine CA US 92612 |
| 3023824846 | 3023824846 | MEDTEC MEDICAL, INC. | 1 | Y | 2026-01-01 | 1000 Asbury Dr Suite 1 Buffalo Grove IL US 60089 |
| 1062273 | 3000210192 | MedTec Biolab, Inc. | 1 | N | 2020-04-25 | 600 MEADOWLAND DR. Hillsborough NC US 27278 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00841439104064 | Precise Bite™ - Mouthpiece | +1(712)737-8688 | radiotherapy.complaints@civcort.com |
| 00841439104071 | Precise Bite™ - Mouthpiece (small) | +1(712)737-8688 | radiotherapy.complaints@civcort.com |
| 00841439104088 | Precise Bite™ - Mouthpiece with tongue depressor | +1(712)737-8688 | radiotherapy.complaints@civcort.com |
| 00841439104095 | Precise Bite™ - Mouthpiece (small) with tongue depressor | +1(712)737-8688 | radiotherapy.complaints@civcort.com |
| 00841439107652 | Shim - For use with Silverman headrests | +1(712)737-8688 | radiotherapy.complaints@civcort.com |
| 00841439107669 | Shim - For use with Timo headrests | +1(712)737-8688 | radiotherapy.complaints@civcort.com |
| 10841439104221 | Nasion Cushion - For use with trUpoint ARCH™ | +1(712)737-8688 | radiotherapy.complaints@civcort.com |
| 10841439104245 | Bite Cup - For use with trUpoint ARCH™ | +1(712)737-8688 | radiotherapy.complaints@civcort.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 62251 | 1451881092 | P880056 | |||
| 154433 | 1585873706 | K994239 | ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2000-06-19 |
| 17629 | 1612559066 | K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 | IYE | 1998-10-26 |
| 17629 | 1137027588 | K974703 | CARBON FIBER BREAST BOARD | IYE | 1998-03-10 |
| 17629 | 1928956041 | K973842 | CARBON FIBER CONFORMAL COUCH TOP | IXQ | 1997-12-05 |
| 31756 | 1798654509 | K960347 | SAFETY TROCER WITH SPRINGLOADED OBDURATOR | HET | 1996-07-01 |
| 17629 | 1835702475 | K952729 | PAINTED WEDGE & ROD BREAST BOARD | IYE | 1995-09-15 |
| 17629 | 2012600127 | K951808 | MED-TEC REDI-FOAM | IYE | 1995-07-06 |
| 17629 | 1518897728 | K951601 | MED-TEC STRING RETICLE TRAY | IWE | 1995-05-11 |
| 17629 | 1687143849 | K950866 | HIP FIXATION SYSTEM | IYE | 1995-05-30 |
| 17629 | 1746154514 | K950068 | CARBON FIBER COUCH INSERT | KXJ | 1995-04-06 |
| 17629 | 1878113861 | K945515 | COATED TUNGSTEN EYESHIELD | IWS | 1995-06-19 |
| 17629 | 1873570084 | K935412 | MED-TEC, INC. BREAST BOARD, MT-200 | IYE | 1994-07-18 |
| 17629 | 1251358885 | K935411 | MED-TEC, INC. BREAST BOARD, MT-250 | IYE | 1994-07-18 |
| 17629 | 1474504761 | K935300 | VAC-LOK IMMOBILIZATION SYSTEM | IYE | 1994-07-18 |
| 17629 | 1228369369 | K933227 | UNI-FRAME HEAD IMMOBILIZATION SYSTEM | IYE | 1994-07-18 |
| 31756 | 1236135288 | K894303 | MEDSCOPE 4MM ARTHROSCOPE | HRX | 1989-07-25 |
| 62251 | 1677108384 | K242803 | Compound W Skin Tag Remover | GEH | 2024-11-06 |
| 62251 | 1844039301 | K240226 | Pixie Skin Tag | ORE | 2024-10-18 |
| 17629 | 1386694145 | K211001 | C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner | IYE | 2021-05-20 |
| 287377 | 1350998989 | K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown | FYC | 2022-10-21 |
| 62251 | 1428745436 | K202974 | DenTek Fresh Protect Dental Guard | OBR | 2020-12-22 |
| 154433 | 1047141200 | K190365 | Baby Gorilla/Gorilla Plating System | HRS | 2019-04-12 |
| 154433 | 1745799648 | K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly | JWH | 2019-03-29 |
| 17629 | 1193948269 | K182079 | Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask | IYE | 2018-09-07 |
| 154433 | 1430172473 | K181410 | MotoCLIP/HiMAX Implant System | JDR | 2018-06-29 |
| 62251 | 1788869551 | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | FRO | 2018-08-17 |
| 62251 | 2054848137 | K180933 | DenTek Ultimate Dental Guard | OBR | 2018-09-17 |
| 17629 | 1050311580 | K180021 | Proton Positioing and Immobilization Devices | IYE | 2018-06-29 |
| 62251 | 1614284437 | K172373 | Compound W Nitro-Freeze | GEH | 2017-11-02 |
| 154433 | 1643829860 | K170923 | JAWS(TM) Nitinol Staple System | JDR | 2017-07-24 |
| 154433 | 1315015148 | K170693 | Phantom Small Bone Intramedullary Nail System | KTW | 2017-06-19 |
| 62251 | 1801340186 | K163401 | Nix Ultra Lice Treatment Kit | LJL | 2017-03-21 |
| 154433 | 1936445026 | K162422 | Klassic Knee System | JWH | 2016-10-28 |
| 154433 | 1417681182 | K162241 | TITAN 3-D™ Wedge System | PLF | 2017-04-03 |
| 62251 | 1320486374 | K161294 | Compound W Wart Removal System Dual Power | GEH | 2016-09-15 |
| 17629 | 1936050925 | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement | IYE | 2016-05-25 |
| 154433 | 1318674112 | K152306 | MotoBand¿ CP Implant System | HRS | 2015-12-11 |
| 154433 | 1771353296 | K152072 | CrossRoads Screw System | HWC | 2015-09-23 |
| 154433 | 1151560625 | K151440 | Klassic HD Hip System | LPH | 2015-09-03 |
| 62251 | 1087725174 | K151309 | Wartie Advanced Wart Remover or other proprietary name | GEH | 2015-08-14 |
| 62251 | 1774534987 | K151149 | Ready-Fit | OBR | 2015-09-30 |
| 154433 | 1157028277 | K143113 | Klassic BiPolar System | KWY | 2015-01-28 |
| 154433 | 1969696205 | K143039 | CrossRoads Screw System | HWC | 2015-01-16 |
| 154433 | 1345823696 | K142727 | CrossCLIP Implant System | JDR | 2014-10-24 |
| 154433 | 1595737110 | K140749 | INFINITY TOTAL ANKLE SYSTEM | HSN | 2014-04-25 |
| 62251 | 1946341096 | K140314 | WARTIE WART REMOVER | GEH | 2014-06-12 |
| 154433 | 1623473128 | K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE | MAX | 2014-07-02 |
| 17629 | 1567145440 | K132908 | TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT | IYE | 2014-03-04 |
| 17629 | 1473629053 | K132084 | PROTURA COUCH SOFTWARE | JAI | 2013-09-26 |
| 62251 | 2046584434 | K130186 | DENTEK EASY BRUSH WITH FLUORIDE | EFW | 2013-07-15 |
| 154433 | 1508005321 | K124027 | MONSTER SCREW SYSTEM | HWC | 2013-04-05 |
| 62251 | 1780133297 | K123849 | NEW COMFORT-FIT DENTAL GUARD | OBR | 2013-01-10 |
| 62251 | 1014155458 | K122663 | ORAMOIST | LFD | 2013-05-30 |
| 17629 | 1577096073 | K122201 | PROTURA COUCH SOFTWARE | JAI | 2012-08-30 |
| 17629 | 1175358546 | K121545 | BELLYBOARD, SBRT ACCESSORIES | LNH | 2012-06-08 |
| 17629 | 1903727345 | K121284 | CHABNER XRT GARMENTS | IYE | 2013-06-14 |
| 17629 | 1624491895 | K120916 | QFIX RADIOTHERAPY CHAIR | JAI | 2012-06-20 |
| 62251 | 1529639877 | K120109 | SUPER SEAL TOOTH DESENSITIZER | LBH | 2012-03-07 |
| 154433 | 1991291831 | K112906 | KLASSIC KNEE SYSTEM | JWH | 2012-02-01 |
| 17629 | 1879445393 | K111340 | HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM | LNH | 2011-06-28 |
| 17629 | 1896046164 | K102753 | TURBO TEMP 3 | EBG | 2011-02-04 |
| 154433 | 1808368119 | K100445 | KLASSIC HD HIP SYSTEM | LPH | 2010-12-03 |
| 62251 | 1860170598 | K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | JMT | 2011-02-17 |
| 17629 | 1850417681 | K093738 | MRI PATIENT POSITIONING DEVICES | LNH | 2010-05-14 |
| 62251 | 1498579867 | K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 | OBR | 2009-06-12 |
| 154433 | 1897457626 | K090353 | PERIMETER INTERBODY FUSION DEVICE | MAX | 2009-09-29 |
| 62251 | 1588769699 | K083400 | CUSTOM COMFORT NIGHTGUARD | OBR | 2008-12-11 |
| 154433 | 1054182596 | K083026 | CLYDESDALE SPINAL SYSTEM | MAX | 2008-12-29 |
| 62251 | 1110200933 | K081669 | IMPROVED COMFORT-FIT NIGHTGUARD | OBR | 2008-07-10 |
| 17629 | 1340847058 | K080072 | MRI PATIENT POSITIONING DEVICES | IYE | 2008-06-04 |
| 62251 | 1615366414 | K073220 | THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT | OBR | 2007-12-19 |
| 17629 | 2049796049 | K071614 | FIDUCIAL MARKERS | IYE | 2007-09-11 |
| 154433 | 2017405953 | K062133 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | MQP | 2006-09-26 |
| 17629 | 1537938165 | K060737 | SINMED POSITIONING DEVICES | IYE | 2006-03-31 |
| 62251 | 1724040977 | K053580 | DOCTOR'S NIGHTGUARD | MQC | 2006-03-03 |
| 17629 | 1995897580 | K034054 | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 | JAI | 2004-02-20 |
| 62251 | 1146563730 | K032271 | WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) | GEH | 2003-09-10 |
| 17629 | 1758531436 | K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | JAI | 2003-08-14 |
| 17629 | 1938207784 | K023293 | MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 | IYE | 2002-12-23 |
| 17629 | 1566648991 | DEN220052 | BrachyGel Vaginal Hydrogel Packing System | QXR | 2023-08-22 |
| 17629 | 1423491984 | DEN220017 | BioXmark | QUV | 2022-12-23 |
| 154433 | 1003802734 | ||||
| 154433 | 1006957589 | ||||
| 17629 | 1109244500 | ||||
| 17629 | 1160143771 | ||||
| 154433 | 1166577238 | ||||
| 62251 | 1186394511 | ||||
| 154433 | 1213917846 | ||||
| 17629 | 1245049989 | ||||
| 154433 | 1251946795 | ||||
| 154433 | 1263031772 | ||||
| 154433 | 1294099715 | ||||
| 154433 | 1325446411 | ||||
| 154433 | 1328047249 | ||||
| 154433 | 1365461033 | ||||
| 154433 | 1377640524 | ||||
| 17629 | 1382838750 | ||||
| 154433 | 1437755855 | ||||
| 154433 | 1452993527 | ||||
| 17629 | 1454569658 | ||||
| 154433 | 1481277857 | ||||
| 15808 | 1501388336 | ||||
| 154433 | 1515744163 | ||||
| 17629 | 1541824434 | ||||
| 17629 | 1599986629 | ||||
| 154433 | 1604293023 | ||||
| 154433 | 1619463342 | ||||
| 154433 | 1650986237 | ||||
| 17629 | 1693898064 | ||||
| 154433 | 1703393146 | ||||
| 17629 | 1728183793 | ||||
| 17629 | 1738476524 | ||||
| 154433 | 1750510976 | ||||
| 154433 | 1764028272 | ||||
| 154433 | 1774081313 | ||||
| 17629 | 1786271066 | ||||
| 154433 | 1806337044 | ||||
| 154433 | 1807971757 | ||||
| 154433 | 1809303442 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYE | 19 | 2021-05-20 |
| OBR | 8 | 2020-12-22 |
| GEH | 6 | 2024-11-06 |
| JAI | 5 | 2013-09-26 |
| JWH | 3 | 2019-03-29 |
| JDR | 3 | 2018-06-29 |
| HWC | 3 | 2015-09-23 |
| MAX | 3 | 2014-07-02 |
| LNH | 3 | 2012-06-08 |
| HRS | 2 | 2019-04-12 |
| LPH | 2 | 2015-09-03 |
| ORE | 1 | 2024-10-18 |
| QXR | 1 | 2023-08-22 |
| QUV | 1 | 2022-12-23 |
| FYC | 1 | 2022-10-21 |
| FRO | 1 | 2018-08-17 |
| KTW | 1 | 2017-06-19 |
| PLF | 1 | 2017-04-03 |
| LJL | 1 | 2017-03-21 |
| KWY | 1 | 2015-01-28 |
| HSN | 1 | 2014-04-25 |
| EFW | 1 | 2013-07-15 |
| LFD | 1 | 2013-05-30 |
| LBH | 1 | 2012-03-07 |
| JMT | 1 | 2011-02-17 |
| EBG | 1 | 2011-02-04 |
| MQP | 1 | 2006-09-26 |
| MQC | 1 | 2006-03-03 |
| KWQ | 1 | 2000-06-19 |
| IXQ | 1 | 1997-12-05 |
| HET | 1 | 1996-07-01 |
| IWS | 1 | 1995-06-19 |
| IWE | 1 | 1995-05-11 |
| KXJ | 1 | 1995-04-06 |
| HRX | 1 | 1989-07-25 |
carboxymethylcellulose sodium
carboxymethylcellulose sodium
carboxymethylcellulose sodium
carboxymethylcellulose sodium
Carboxymethylcellulose Sodium, Unspecified Form
Carboxymethylcellulose Sodium, Unspecified
carboxymethylcellulose sodium
PHENOL
benzocaine and dextromethorphan HBr
Dextromethorphan Hydrobromide and Guaifenesin
Magnesium Salicylate
Acetaminophen and Diphenhydramine HCl
acetaminophen and diphenhydramine
simthicone
Phenazopyridine Hydrochloride
Aspirin and Caffeine
Aspirin, Acetaminophen, Caffeine
Diphenhydramine HCl
Cimetidine
Cimetidine
Aspirin
Aspirin
Carbamide Peroxide
isopropyl alcohol
polyvinyl alcohol and povidone
isopropyl alcohol
Carbamide Peroxide
Aspirin and Caffeine
Diphenhydramine HCl
Benzocaine
DIPHENHYDRAMINE HYDROCHLORIDE
salicylic acid
salicylic acid
salicylic acid
salicylic acid
salicylic acid
salicylic acid
salicylic acid
salicylic acid
Acetaminophen and Asprin
Medtech Products, Inc.
Medtech S.A.S
Medtecs (Taiwan) Corp.
Medtech S.A.S
Medtecs (Taiwan) Corp.
MEDTEC, Inc. Dba CIVCO Medical Solutions And CIVCO
Medtech Products, Inc.
Medtech S.A.
MEDTECH S.A.
Medtech S.A.
MEDTECH S.A.
Medtech Products Inc.
MEDTEC Inc. Dba CIVCO Medical Solutions
MEDTEC, Inc. D/b/a "CIVCO Medical Solutions" And "CIVCO Radi
MEDTECH S.A.
Medtech Products Inc.
MEDTECH PRODUCTS INC.
MEDTECH PRODUCTS INC.
MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
MEDTECH S.A.
MEDTECH S.A.
MEDTEC, INC.
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
MEDTEC, INC.
MEDTECH SAS
MEDTEC, INC.
MEDTECH S.A.
MEDTECHS, LLC
MEDTECHS, LLC
MEDTECH PRODUCTS LTD.
MEDTECH SYSTEMS, INC.
MEDTECH PRODUCTS LTD.
MEDTECH PRODUCTS LTD.
MEDTECH PRODUCTS LTD.
MEDTECH LTD.
MEDTEC, INC.
MEDTEC, INC.
MEDTECH INSTRUMENTS
MEDTEC, INC.
MEDTEC, INC.
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