TEENY TUMMY
Simethicone
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1723686 | 3000214920 | Altivera Medical, Inc. | 1 | N | 2026-01-01 | 8181 E Tufts Ave Ste 200 Denver CO US 80237 |
| 2084170 | 2084170 | ALTA DIAGNOSTICS, INC. | 1 | N | 2026-01-01 | 3123 Research Way Ste 214 Carson City NV US 89706 |
| 2126684 | 2126684 | Altimate Medical, Inc. | 1 | N | 2026-01-01 | 101 ACTIVEAID RD. Redwood Falls MN US 56283 |
| 2183634 | 2183634 | ALTIMATE MEDICAL, INC. | 1 | N | 2026-01-01 | 262 WEST FIRST ST. MORTON MN US 56270 |
| 2242056 | 2242056 | ALTO DEVELOPMENT CORP. | 1 | Y | 2026-01-01 | 5206 Asbury Road FARMINGDALE NJ US 07727 |
| 2335740 | 1000119582 | ALTAIRE PHARMACEUTICALS, INC. | 1 | N | 2026-01-01 | 311 WEST LN. AQUEBOGUE NY US 11931 |
| 2951094 | 1000150804 | ALTAIR EYEWEAR | 1 | Y | 2026-01-01 | 10875 INTERNATIONAL DR. RANCHO CORDOVA CA US 95670 |
| 9613866 | 3002806355 | ALTATEC GMBH | 1 | N | 2026-01-01 | MAYBACHSTRASSE 5 WIMSHEIM Baden-Wurttemberg DE D-71299 |
| 3003760853 | 3003760853 | Altimate Medical, Inc. | 1 | N | 2026-01-01 | 9450 W LARAWAY RD Frankfort IL US 60423 |
| 3007603422 | 3007603422 | Althea US, Inc. | 1 | N | 2026-01-01 | 101 Old Stone Bridge Goodlettsville TN US 37072 |
| 3007884119 | 3007884119 | Altasciences CDMO Philadelphia, LLC | 1 | N | 2026-01-01 | 1510 Delp Drive 1508 Delp Drive Harleysville PA US 19438 |
| 3009049161 | 3009049161 | ALTUS PARTNERS | 1 | N | 2026-01-01 | 1340 ENTERPRISE DR WEST CHESTER PA US 19380 |
| 3009492406 | 3009492406 | Altona Diagnostics USA, Inc. | 1 | Y | 2026-01-01 | 8120 Corporate Boulevard Plain City OH US 43064 |
| 3013633270 | 3013633270 | ALTAVIZ, LLC | 1 | N | 2026-01-01 | 13766 Alton Parkway Suite 143 Irvine CA US 92618 |
| 3014897003 | 3014897003 | Altrazeal Life Sciences Inc. | 1 | N | 2026-01-01 | 15020 Beltway Dr Addison TX US 75001 |
| 3016966810 | 3016966810 | ALTOR SAFETY | 1 | N | 2026-01-01 | 711 Executive Blvd Suite C Valley Cottage NY US 10989 |
| 3017138012 | 3017138012 | ALTA SMILES, LLC | 1 | N | 2026-01-01 | 1300 Virginia Drive Suite 119 Fort Washington PA US 19034 |
| 3017936974 | 3017936974 | Altivera Medical, Inc. | 1 | N | 2026-01-01 | 14800 Grasslands Drive Englewood CO US 80112 |
| 3018069403 | 3018069403 | ALTAMONT SOFTWARE, INC. | 1 | N | 2026-01-01 | 127 Spring Street, Suite 110 Pleasanton CA US 94566 |
| 3029802591 | 3029802591 | ALTANOVATE INC. | 1 | Y | 2026-01-01 | 500 Wheeler Rd Ste C Hauppauge NY US 11788 |
| 3029833867 | 3029833867 | ALTA MEDICAL LLC | 1 | N | 2026-01-01 | 729 W Historic Mitchell St Milwaukee WI US 53204 |
| 3030311186 | 3030311186 | Altek Medical Sdn. Bhd. | 1 | N | 2026-01-01 | No. 12, Jalan Teknologi Perintis 1/3, Taman Teknologi Nusajaya, Iskandar Puteri Johor MY 79200 |
| 3030650077 | 3030650077 | ALT-BIONICS, INC. | 1 | N | 2026-01-01 | 5039 Beckwith Blvd Ste 109 San Antonio TX US 78249 |
| 3036565577 | 3036565577 | ALTHERY, LLC | 1 | Y | 2026-01-01 | 90 Executive Dr Ste E Carmel IN US 46032 |
| 2024148 | 2024148 | ALTAIR INSTRUMENTS, INC. | 1 | N | 2020-04-25 | 4864 MARKET ST STE D Ventura CA US 93003 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 52984 | 1777989334 | K991241 | IF8000 | IPF | 1999-11-02 |
| 6380 | 1422244976 | K964621 | A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON | GEI | 1996-12-20 |
| 6380 | 1456963208 | K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | GAO | 1994-01-07 |
| 6380 | 1780256396 | K930528 | A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS | GEI | 1993-05-17 |
| 52984 | 1312182412 | K914925 | MEDAC SYSTEM/3 | HCC | 1993-10-21 |
| 52984 | 1908309423 | K914920 | BIOFEEDBACK SYSTEM/3 | HCC | 1992-11-16 |
| 6380 | 1147784360 | K914193 | A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT | GEI | 1992-10-05 |
| 42316 | 1737045822 | K890577 | KENLOR LIQUID URINE CONTROL | JJW | 1989-03-09 |
| 174991 | 1534809228 | K885343 | STANDEX | ION | 1989-05-01 |
| 6380 | 1564355887 | K884783 | RANEY CLIP | FZQ | 1988-11-30 |
| 6380 | 1352822450 | K881413 | ELECTRO-CAUTERY SUCTION TUBE | GEI | 1988-04-21 |
| 6380 | 1073927722 | K803086 | MYOWIRE-ATEMPORARY CARDIAC PACING WIRE | LDF | 1981-07-01 |
| 127790 | 1752361924 | K243419 | Altus Spine Navigation System | OLO | 2025-05-08 |
| 52984 | 1991787748 | K241228 | TENSWave | GZJ | 2024-08-27 |
| 287038 | 1991787748 | K241228 | TENSWave | GZJ | 2024-08-27 |
| 287038 | 1765632907 | K233485 | M-Wave | IPF | 2024-01-26 |
| 312089 | 1869097538 | K231261 | Altaviz Needle Kit II | FMI | 2023-07-27 |
| 127790 | 1044785536 | K230766 | Altus Spine Monaco Pedicle Screw System | NKB | 2023-04-19 |
| 312089 | 1284050093 | K222681 | Altaviz Needle Kit | FMI | 2022-12-05 |
| 287038 | 1402548086 | K222669 | Cryopush Cold Compression Device | IRP | 2022-12-05 |
| 127790 | 1364511938 | K211837 | Altus Spine Interbody Standalone Fusion System | OVD | 2022-04-19 |
| 270345 | 1834634936 | K211762 | Altor Safety 4-Ply Surgical Mask (Model:62232) | FXX | 2021-09-03 |
| 270345 | 1865331653 | K211249 | Altor Safety 3-Ply Surgical Mask (Model:62222) | FXX | 2021-07-23 |
| 127790 | 1045852264 | K211027 | Altus Spine Pedicle Screw System | NKB | 2022-09-16 |
| 127790 | 1019891266 | K210887 | Altus Spine Sochi OCT Spinal System | NKG | 2021-08-20 |
| 127790 | 1319213944 | K200922 | Altus Spine HA Pedicle Screw System | NKB | 2021-01-26 |
| 127790 | 1795036713 | K200322 | Altus Spine Pedicle Screw System | NKB | 2020-06-02 |
| 6380 | 1949488467 | K193479 | Sternal Cable System | JDQ | 2020-03-23 |
| 64931 | 1796531299 | K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | DZE | 2020-09-29 |
| 127790 | 1178475166 | K183084 | Fuji Cervical Plate System | KWQ | 2019-05-29 |
| 127790 | 1215286168 | K182406 | Altus Spine Interbody Fusion System | MAX | 2019-02-22 |
| 6380 | 1873384600 | K181607 | Thorecon Rigid Fixation System | JDQ | 2018-10-12 |
| 127790 | 1031844371 | K181339 | Altus Spine Pedicle Screw System | NKB | 2018-07-24 |
| 127790 | 1033223613 | K181281 | Altus Spine Pedicle Screw System | NKB | 2018-06-11 |
| 127790 | 1393148360 | K172253 | Altus Spine Cervical Interbody Fusion System | ODP | 2017-11-21 |
| 127790 | 1030435926 | K171329 | Altus Spine Titanium Interbody Fusion System | MAX | 2017-08-29 |
| 127790 | 1719658523 | K170553 | Altus Spine Interbody Fusion System | MAX | 2017-12-01 |
| 127790 | 1322116020 | K170512 | Altus Spine Titanium Interbody Fusion System | MAX | 2017-03-10 |
| 127790 | 2073425586 | K163061 | Altus Spine Cervical Plate System | KWQ | 2017-02-06 |
| 127790 | 1572321017 | K160976 | Altus Spine Interbody Fusion System | MAX | 2017-01-25 |
| 64931 | 1576339582 | K160784 | CAM Titanium Blanks | NHA | 2016-09-14 |
| 64931 | 1814104447 | K153779 | Abutment for Bridges | NHA | 2016-03-31 |
| 64931 | 1369141176 | K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | NHA | 2016-01-12 |
| 127790 | 1348307413 | K151648 | Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System | NKB | 2015-10-16 |
| 64931 | 1550694417 | K151599 | iSy Implant System | DZE | 2015-10-02 |
| 64931 | 1991775283 | K143337 | CONELOG Titanium base CAD/CAM | NHA | 2015-02-17 |
| 64931 | 1083332967 | K133991 | ISY | DZE | 2014-08-06 |
| 127790 | 1954079792 | K132280 | ALTUS SPINE PEDICLE SCREW SYSTEM | MNI | 2013-10-31 |
| 174991 | 1128700780 | K123834 | EASYSTAND BANTAM MEDIUM | INO | 2013-08-13 |
| 52984 | 2049338768 | K121820 | INWAVE | KPI | 2012-08-24 |
| 287038 | 2049338768 | K121820 | INWAVE | KPI | 2012-08-24 |
| 64931 | 1437580942 | K113779 | CONELOG IMPLANT SYSTEM | DZE | 2012-12-14 |
| 52984 | 1586692400 | K111279 | NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM | IPF | 2011-09-20 |
| 287038 | 1586692400 | K111279 | NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM | IPF | 2011-09-20 |
| 64931 | 1180292959 | K103252 | CAMLOG VARIO SR ABUTMENTS | NHA | 2011-01-10 |
| 127790 | 1458308964 | K091396 | CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2009-08-05 |
| 174991 | 1180918875 | K091242 | BANTAM | INO | 2009-07-06 |
| 64931 | 1051644220 | K090347 | CAMLOG ABUTMENTS PS | NHA | 2009-06-18 |
| 64931 | 1412669963 | K083496 | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS | DZE | 2009-01-30 |
| 127790 | 1304416744 | K081597 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | MNI | 2008-07-02 |
| 127790 | 1116244745 | K081567 | VERTEBRON SSP CERVICAL PLATING SYSTEM | KWQ | 2008-07-03 |
| 64931 | 1884145202 | K073553 | CAMLOG IMPLANT SYSTEM ABUTMENTS | NHA | 2008-03-05 |
| 127790 | 1679178262 | K073531 | ACCIN PEDICLE SCREW SYSTEM | MNH | 2008-02-04 |
| 127790 | 1929461504 | K073530 | ACCIN ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2008-01-31 |
| 127790 | 1957813531 | K073502 | VERTEBRON VBR SYSTEM | MQP | 2008-03-24 |
| 127790 | 1472801989 | K071376 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | NKB | 2007-06-13 |
| 174991 | 1424197702 | K062402 | EASYSTAND EVOLV | INO | 2006-09-21 |
| 20130 | 1792503391 | K062332 | ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION | LPN | 2007-04-25 |
| 127790 | 1037554922 | K062110 | VERTEBRON SCP CERVICAL PLATE SYSTEM | KWQ | 2006-08-16 |
| 127790 | 1219320723 | K051815 | MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM | KWQ | 2005-10-17 |
| 127790 | 1407865086 | K051716 | VERTEBRON PSS PEDICLE SCREW SYSTEM | KWP | 2005-09-07 |
| 64931 | 1877375915 | K051636 | CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES | NHA | 2006-02-17 |
| 127790 | 1815789241 | K043181 | MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM | KWQ | 2004-12-17 |
| 127790 | 1061623243 | K043152 | VERTEBRON PSS PEDICLE SCREW SYSTEM | MNH | 2005-02-01 |
| 127790 | 1281262192 | K040003 | VERTEBRON SCP CERVICAL PLATE SYSTEM | KWQ | 2004-03-26 |
| 6380 | 1390297543 | K033858 | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE | LDF | 2004-07-12 |
| 127790 | 1196837164 | K033352 | VERTEBRON PSS PEDICLE SCREW SYSTEM | MNI | 2004-02-25 |
| 64931 | 1765361527 | K032448 | ALTATEC CERAMIC ABUTMENT | NHA | 2003-08-22 |
| 52984 | 1870996629 | K013210 | TRUWAVE | GZJ | 2002-04-04 |
| 52984 | 1985617405 | K012885 | NEUROMOVE NM900 | IPF | 2001-11-08 |
| 287038 | 1985617405 | K012885 | NEUROMOVE NM900 | IPF | 2001-11-08 |
| 52984 | 1291109186 | K010745 | EMS 3000 | IPF | 2001-06-27 |
| 64931 | 1391905537 | K000100 | CAMLOG ROOTFORM IMPLANT SYSTEM | DZE | 2000-01-28 |
| 60993 | 1037119372 | ||||
| 60993 | 1152327962 | ||||
| 60993 | 1162181481 | ||||
| 60993 | 1313080081 | ||||
| 60993 | 1362033613 | ||||
| 221923 | 1467362123 | ||||
| 60993 | 1536919933 | ||||
| 60993 | 1685577921 | ||||
| 34436 | 1852086107 | ||||
| 60993 | 1905851940 | ||||
| 42316 | 1974571442 | ||||
| 321964 | 1003410989 | ||||
| 326325 | 1020547397 | ||||
| 60993 | 1022033847 | ||||
| 6380 | 1039290997 | ||||
| 64931 | 1040351930 | ||||
| 325964 | 1056036440 | ||||
| 326325 | 1062129970 | ||||
| 35641 | 1082012164 | ||||
| 20130 | 1110304876 | ||||
| 60993 | 1126318941 | ||||
| 60993 | 1133927395 | ||||
| 60993 | 1135479615 | ||||
| 325964 | 1140122691 | ||||
| 270345 | 1141813468 | ||||
| 325964 | 1145304741 | ||||
| 64931 | 1146261687 | ||||
| 325964 | 1161256563 | ||||
| 20130 | 1180015390 | ||||
| 60993 | 1199260811 | ||||
| 60993 | 1204164514 | ||||
| 326325 | 1211463086 | ||||
| 20130 | 1228073549 | ||||
| 60993 | 1257072118 | ||||
| 6380 | 1263414790 | ||||
| 327198 | 1264411515 | ||||
| 60993 | 1289132752 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KWQ | 9 | 2019-05-29 |
| NHA | 9 | 2016-09-14 |
| NKB | 8 | 2023-04-19 |
| IPF | 7 | 2024-01-26 |
| DZE | 6 | 2020-09-29 |
| MAX | 5 | 2019-02-22 |
| GEI | 4 | 1996-12-20 |
| GZJ | 3 | 2024-08-27 |
| MNI | 3 | 2013-10-31 |
| INO | 3 | 2013-08-13 |
| FMI | 2 | 2023-07-27 |
| FXX | 2 | 2021-09-03 |
| JDQ | 2 | 2020-03-23 |
| KPI | 2 | 2012-08-24 |
| MNH | 2 | 2008-02-04 |
| LDF | 2 | 2004-07-12 |
| HCC | 2 | 1993-10-21 |
| OLO | 1 | 2025-05-08 |
| IRP | 1 | 2022-12-05 |
| OVD | 1 | 2022-04-19 |
| NKG | 1 | 2021-08-20 |
| ODP | 1 | 2017-11-21 |
| MQP | 1 | 2008-03-24 |
| LPN | 1 | 2007-04-25 |
| KWP | 1 | 2005-09-07 |
| GAO | 1 | 1994-01-07 |
| ION | 1 | 1989-05-01 |
| JJW | 1 | 1989-03-09 |
| FZQ | 1 | 1988-11-30 |
Simethicone
BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dextromethorphan HBr, Guaifenesin
Ofloxacin
Diclofenac Sodium
polyvinyl alcohol, povidone and tetrahydrozoline hydrochloride
NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE
HYPROMELLOSE 2906 (4000 MPA.S)
Sodium Chloride
Sodium Chloride
Homatropine Hydrobromide
Mineral oil and petrolatum
Fluorescein Sodium and Proparacaine Hydrochloride
Ciprofloxacin Hydrochloride
Fluorescein Sodium and Benoxinate Hydrochloride
OXYGEN
Sotalol hydrochloride
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
OCTINOXATE
Altacor Ltd.merlin House, Brunel Roadtheale RG7 4 PMA NumberP960011 Supplement NumberS034 Date Received09/08/2022 Decision Date10/03/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufac...
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