HEPLISAV-B
Hepatitis B Vaccine (Recombinant) Adjuvanted
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1121034 | 1121034 | DYNASPLINT SYSTEMS, INC. | 1 | N | 2026-01-01 | 150 LOG CANOE CIRCLE STEVENSVILLE MD US 21666 |
| 1932270 | 1000119187 | DYNA-TEK, INC. | 1 | N | 2026-01-01 | 14048 W 107th St LENEXA KS US 66215 |
| 2431014 | 2431014 | DYNAREX CORP. | 1 | Y | 2026-01-01 | 11 Dynarex Drive Middletown NY US 10941 |
| 3004028690 | 3004028690 | Dynamic Group | 1 | N | 2026-01-01 | 13911 Unity Street NW Ramsey MN US 55303 |
| 3005301283 | 3005301283 | DYNAVOX Group AB | 1 | N | 2026-01-01 | Lojtnantsgatan 25 Stockholm SE SE11550 |
| 3006227741 | 3006227741 | DYNAMIC TECHNO MEDICALS PRIVATE LIMITED | 1 | N | 2026-01-01 | SF No. 138 & 137/2C, Rayarthottam, Trichy Road, Kannampalayam, S Coimbatore Tamil Nadu IN 641402 |
| 3008776780 | 3008776780 | Dynasthetics | 1 | N | 2026-01-01 | 3487 W 2100 S 300 Salt Lake City UT US 84119 |
| 3010197315 | 3010197315 | Dynavision Global Holdings LLC | 1 | N | 2026-01-01 | 7865 Palace Drive Cincinnati OH US 45249 |
| 3010230734 | 3010230734 | DYNAMIC DIAGNOSTICS INCORPORATED | 1 | Y | 2026-01-01 | 800 Junction St Plymouth MI US 48170 |
| 3011555947 | 3011555947 | Dynamic solution Co., Ltd | 1 | N | 2026-01-01 | 809, 42, Changeop-ro, Sujeong-gu Seongnam-si Gyeonggi KR 13449 |
| 3012452932 | 3012452932 | DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD. | 1 | N | 2026-01-01 | No. 2 Building, Rongzhi Industry Park, No. 3667, Zhongbin Avenue Tianjin CN 300467 |
| 3012832277 | 3012832277 | Dynasol International Inc | 1 | Y | 2026-01-01 | 4420 Baldwin Ave El Monte CA US 91731 |
| 3013341368 | 3013341368 | DYNAFLEX TECHNOLOGIES | 1 | N | 2026-01-01 | 9 Goddard Irvine CA US 92618 |
| 3019512297 | 3019512297 | Dynamic Devices | 1 | N | 2026-01-01 | 41715 N. 41st Street Anthem AZ US 85086 |
| 3021641087 | 3021641087 | DYNACARE SDN BHD | 1 | N | 2026-01-01 | Lot 15528 (PT5001) Kawasan Perusahaan Kampung Acheh Sitiawan Perak MY 32000 |
| 3027718340 | 3027718340 | DYNAPULSE MEDICAL LLC | 1 | Y | 2026-01-01 | 13500 Wayzata Blvd. Minnetonka MN US 55305 |
| 3030427687 | 3030427687 | DynaMedic Co., Ltd. | 1 | N | 2026-01-01 | #406, #506, 125 Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu Cheongju-si Chungbuk KR 28161 |
| 3038288163 | 3038288163 | Dynamic Techno Medicals Pvt. Ltd | 1 | N | 2026-01-01 | Plot No E-1, Sipcot Industrial Growth Centre, Sipcot Main Road P.V.Palayam Post, Perundurai Erode Tamil Nadu IN 638052 |
| 1645338 | 1000118361 | DYNATEC SCIENTIFIC LABORATORIES, INC. | 1 | N | 2020-04-25 | 11940 GOLDEN GATE RD. EL PASO TX US 79936 |
| 1719362 | 1719362 | DYNATRONICS CORP. | 1 | Y | 2020-04-25 | 7030 PARK CENTRE DR. Salt Lake City UT US 84121 |
| 1000643136 | 1000643136 | DYNATRONICS CORP. CHATTANOOGA OPERATIONS | 1 | Y | 2020-04-25 | 6607 MOUNTAIN VIEW RD. College Dale TN US 37363 |
| 3006703870 | 3006703870 | Dynamic Connect (Suzhou) Hi-Tech Electronics Co. Ltd. | 1 | N | 2020-04-25 | Unit C&D, No: 201 Wu Xiang No. 200 Suhong Road Jiangsu Jiangsu CN 215021 |
| 3007602361 | 3007602361 | DYNADX CORPORATION | 1 | N | 2020-04-25 | 406 Tasman Dr Sunnyvale CA US 94089 |
| 3012962636 | 3012962636 | DYNAMIC CONCEPTS MFG | 1 | N | 2020-04-25 | 1836 Stout Dr Ste 8 Warminster PA US 18974 |
| 3013679519 | 3013679519 | DYNAMD | 1 | N | 2020-04-25 | 15900 Old 41 Unit 110 Naples FL US 34110 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 69016 | 1151693368 | K970426 | VALUETRODE | GXY | 1997-05-09 |
| 44894 | 1010812485 | K964771 | DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 | DIF | 1997-02-04 |
| 69016 | 1179356393 | K961250 | DYNATRON 125 ULTRASOUND | IMI | 1996-08-26 |
| 69016 | 1591916326 | K950349 | DYNATRON 950 | LIH | 1995-09-13 |
| 69016 | 1379462065 | K950348 | DYNATRON 650 | LIH | 1995-09-13 |
| 69016 | 1683061114 | K941577 | DYNATRON 550 | LIH | 1995-09-01 |
| 69016 | 2048595869 | K941461 | DYNATRON 850 | LIH | 1995-09-01 |
| 326370 | 1775420351 | K911938 | DYNAVISION 2000 | LQD | 1991-08-02 |
| 44894 | 1071073678 | K904326 | DE-TOX TUBES A AND DE-TOX TUBES B | DPA | 1991-01-17 |
| 160208 | 1404393666 | K230932 | ANDORATE® Valve Kit | OCX | 2023-07-07 |
| 301602 | 1790834260 | K223221 | Non-Sterile Powder Free Nitrile Examination Gloves | LZA | 2023-01-13 |
| 160208 | 1934488761 | K223171 | AquaPulse® Irrigation Tubing | OCX | 2022-11-10 |
| 122687 | 1714416940 | K220591 | Proxima | NFB | 2022-12-15 |
| 160208 | 1134264901 | K192035 | EvaQMax Smoke Evacuation System | FYD | 2019-08-29 |
| 37097 | 1321410163 | K172266 | Dynarex Three-Way Stopcock | FMG | 2018-03-14 |
| 37097 | 1158353783 | K152970 | Dynarex Xeroform Petrolatum Dressing | FRO | 2016-10-03 |
| 69016 | 1305636288 | K151640 | ELTRAC 471 | ITH | 2015-10-16 |
| 37097 | 1916275593 | K151575 | Dynarex Eye Cups | LXQ | 2015-09-01 |
| 160208 | 1404464794 | K143103 | PROPENCIL Smoke Pencil | GEI | 2015-07-16 |
| 319326 | 1301095396 | K141919 | VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR | NGX | 2015-06-16 |
| 69016 | 1544984097 | K132057 | DYNATRON PELTIER THERMOSTIM PROBE | GXY | 2014-01-24 |
| 69016 | 1438060627 | K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | GXY | 2013-07-17 |
| 69016 | 2055217258 | K113250 | DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE | ILY | 2012-02-09 |
| 160208 | 1457080116 | K092732 | PROPENCIL ESU PENCIL | GEI | 2009-11-25 |
| 122687 | 1757709205 | K092031 | VAPOR-CLEAR, MODEL 100 | CBN | 2010-04-16 |
| 160208 | 1874304155 | K091672 | DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES | GEI | 2009-12-04 |
| 37097 | 1448850672 | K082863 | DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) | KNT | 2009-01-09 |
| 37097 | 1176375539 | K081569 | DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS | LZA | 2008-09-12 |
| 69016 | 1135722808 | K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | EGJ | 2008-06-18 |
| 160208 | 1849373536 | K073360 | PROPLATE | GEI | 2007-12-19 |
| 319326 | 1845952336 | K072252 | VEINOPLUS NEUROMUSCULAR STIMULATOR | IPF | 2008-01-30 |
| 207212 | 1592293420 | K070855 | SLEEP QUALITY | MNR | 2008-03-20 |
| 69016 | 1205996057 | K060814 | DYNATRON ION IONTOPHORESIS ELECTRODE | EGJ | 2006-06-14 |
| 37097 | 1333137195 | K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | CBP | 2005-12-22 |
| 69016 | 1868023611 | K052453 | TRACTION SYSTEM, DIGIT-TRAC 930 | ITH | 2006-01-13 |
| 69016 | 1812593096 | K043047 | DYNATRON IBOX IONTOPHORESIS DEVICE | EGJ | 2005-01-07 |
| 69016 | 1492775112 | K040729 | SOLARIS D890 THERAPY PROBE | ILY | 2004-06-02 |
| 69016 | 1061187894 | K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) | IMI | 2003-10-22 |
| 37097 | 1498558905 | K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 | FRO | 2002-10-17 |
| 69016 | 2007820551 | K012522 | WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL | ITX | 2001-10-18 |
| 69016 | 1371779821 | K000947 | ULTRASTIM ELECTRODE, MODEL US4040 | GXY | 2000-06-16 |
| 69017 | 1003112924 | ||||
| 45133 | 1014564496 | ||||
| 197249 | 1194219695 | ||||
| 69017 | 1197762372 | ||||
| 69017 | 1224059687 | ||||
| 209003 | 1281641691 | ||||
| 45133 | 1343703542 | ||||
| 69017 | 1355207029 | ||||
| 69017 | 1358021289 | ||||
| 69017 | 1365921731 | ||||
| 177619 | 1370659919 | ||||
| 69017 | 1379537271 | ||||
| 201264 | 1388940556 | ||||
| 69017 | 1393909288 | ||||
| 177619 | 1434618137 | ||||
| 177619 | 1455288573 | ||||
| 209003 | 1501304685 | ||||
| 177619 | 1510262489 | ||||
| 69017 | 1524643623 | ||||
| 69017 | 1534738442 | ||||
| 69017 | 1602882514 | ||||
| 69017 | 1605263882 | ||||
| 69017 | 1646317810 | ||||
| 69017 | 1670878605 | ||||
| 69017 | 1689974560 | ||||
| 177619 | 1719063114 | ||||
| 177619 | 1729972986 | ||||
| 69017 | 1761098690 | ||||
| 69017 | 1776358577 | ||||
| 201264 | 1801746690 | ||||
| 69017 | 1871569815 | ||||
| 138234 | 1909763473 | ||||
| 177619 | 1923735702 | ||||
| 209003 | 1932917833 | ||||
| 83640 | 1950334082 | ||||
| 138234 | 2052306601 | ||||
| 197249 | 2073547359 | ||||
| 138234 | 1013608831 | ||||
| 324233 | 1031582929 | ||||
| 138234 | 1053658943 | ||||
| 138234 | 1059875008 | ||||
| 138234 | 1073093873 | ||||
| 138234 | 1081155467 | ||||
| 138234 | 1093966783 | ||||
| 230446 | 1123004607 | ||||
| 138234 | 1132706479 | ||||
| 138234 | 1168472514 | ||||
| 138234 | 1173970495 | ||||
| 29606 | 1187479355 | ||||
| 138234 | 1202227773 | ||||
| 138234 | 1254878931 | ||||
| 29606 | 1276747936 | ||||
| 324233 | 1282252571 | ||||
| 138234 | 1302634520 | ||||
| 138234 | 1306344470 | ||||
| 138234 | 1307562000 | ||||
| 160208 | 1316005811 | ||||
| 138234 | 1326560708 | ||||
| 65553 | 1332238267 | ||||
| 160208 | 1333714777 | ||||
| 29606 | 1380267417 | ||||
| 138234 | 1407317410 | ||||
| 138234 | 1421052906 | ||||
| 339377 | 1421052906 | ||||
| 293737 | 1428651003 | ||||
| 138234 | 1470086548 | ||||
| 138234 | 1473202830 | ||||
| 138234 | 1489526900 | ||||
| 138234 | 1520241575 | ||||
| 138234 | 1547337775 | ||||
| 97642 | 1564277283 | ||||
| 138234 | 1567457140 | ||||
| 160208 | 1574325254 | ||||
| 138234 | 1578314327 | ||||
| 177619 | 1636641289 | ||||
| 138234 | 1638407208 | ||||
| 29606 | 1645184508 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEI | 4 | 2015-07-16 |
| GXY | 4 | 2014-01-24 |
| LIH | 4 | 1995-09-13 |
| EGJ | 3 | 2008-06-18 |
| OCX | 2 | 2023-07-07 |
| LZA | 2 | 2023-01-13 |
| FRO | 2 | 2016-10-03 |
| ITH | 2 | 2015-10-16 |
| ILY | 2 | 2012-02-09 |
| IMI | 2 | 2003-10-22 |
| NFB | 1 | 2022-12-15 |
| FYD | 1 | 2019-08-29 |
| FMG | 1 | 2018-03-14 |
| LXQ | 1 | 2015-09-01 |
| NGX | 1 | 2015-06-16 |
| CBN | 1 | 2010-04-16 |
| KNT | 1 | 2009-01-09 |
| MNR | 1 | 2008-03-20 |
| IPF | 1 | 2008-01-30 |
| CBP | 1 | 2005-12-22 |
| ITX | 1 | 2001-10-18 |
| DIF | 1 | 1997-02-04 |
| LQD | 1 | 1991-08-02 |
| DPA | 1 | 1991-01-17 |
Hepatitis B Vaccine (Recombinant) Adjuvanted
Antiseptic
Antipruritic (Anti-Itch)
Petrolatum
Skin Protectant
Burn First Aid
First Aid Antibiotic
Lidocaine Pain Relief
Hand Sanitizer
Isopropyl Alcohol Spray
Antiseptic Spray
1168 Burn Spray
1169 Hydrogen Peroxide Spray
Calmara
Pain Relieving Cream
Bacitracin
Isopropyl Alcohol
Lidocaine Hydrochloride
Antidandruff Shampoo
Povidone Iodine Prep Solution
Povidone Iodine Surgical Scrub Solution
Cold Therapy Gel
Moisturizer
Glycerin
Sodium Fluoride
1177, 1178 Sunscreen
Clear Mint, Gel Toothpaste
White Toothpaste
Morning Fresh Mint Toothpaste, with Fluoride
Bubble Fresh Toothpaste, with Fluoride
Hot Cold Patch
PETROLATUM
PETROLATUM
bacitracin zinc, neomycin sulfate and polymyxin b sulfate
Neomycin Ointment
Zinc Oxide Ointment
antifungal
Menthol and Zinc Oxide
Durma DynaGel
Benzalkonium Chloride
Dyna Flex
Dynacare Sdn Bhd
Dynasthetics, LLC
DynaFlex
Dynarex Corporation
DYNAREX CORPORATION
DYNAREX CORPORATION
DYNATRONICS CORP.
DYNATRONICS CORPORATION
DYNA FLEX
DYNATRONICS CORP.
DYNAMIC INNOVATIONS INC.
DYNAREX CORPORATION
DYNAFLEX
DYNAREX CORPORATION
DYNACARDIA, INC.
DYNAREX CORPORATION
DYNAMITECH MEDICAL, INC
DYNAREX CORPORATION
DYNAREX CORPORATION
DYNADX CORPORATION
DYNATRONICS CORP.
DYNAREX CORP.
DYNAREX CORP.
DYNATRONICS CORP.
DYNATRONICS CORP.
DYNATRONICS CORP.
DYNAMIC IMAGING INC.
DYNATHERM MEDICAL, INC.
DYNATRONICS CORP.
DYNATRONICS CORP.
DYNAMIC IMAGING INC.
DYNAMIC AIR, INC.
DYNAREX CORP.
DYNAREX CORP.
DYNASCEND CONSULTING INT'L LLC.
DYNAREX CORP.
DYNAMIC IMAGING LTD.
DYNATRONICS CORP.
DYNATRONICS CORP.
2019-09-26
2019-09-30
2019-09-30
2019-09-30
2023-01-11
2023-01-11
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2019-05-06
2019-09-30
2018-05-26
2018-05-26
2018-05-26
2019-11-25
2019-11-25
2019-11-25
2019-11-25
2026-06-01
2021-09-01
2022-05-02
2022-05-10
2022-05-10
2022-05-10
2022-05-10
2022-05-10
2022-05-10
2022-05-10
2021-04-22
2021-04-22
2021-09-01
2021-06-21