Zylast Antiseptic
Ethyl Alcohol
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1064152 | 3002668781 | INNOVATIVE ENDOSCOPY COMPONENTS, LLC. | 1 | Y | 2026-01-01 | 320 International Pkwy Sunrise FL US 33325 |
| 1223419 | 1000137654 | INNOVATIVE MEDICAL PRODUCTS, INC. | 1 | Y | 2026-01-01 | 87 SPRING LN. PLAINVILLE INDUSTRIAL PARK PLAINVILLE CT US 06062 |
| 1645361 | 1000117853 | INNOVATIVE HEALTHCARE CORPORATION | 1 | Y | 2026-01-01 | 8220 CHARLES PAGE BLVD SAND SPRINGS OK US 74063 |
| 1833497 | 1000115498 | INNOVATIVE PRODUCTS UNLIMITED, INC. | 1 | Y | 2026-01-01 | 2120 INDUSTRIAL DR. Niles MI US 49120 |
| 1933913 | 3001451226 | INNOVATIVE MEDICAL TECHNOLOGIES, INC | 1 | Y | 2026-01-01 | 16904 Rosehill St Overland Park KS US 66221 |
| 2321034 | 3003399884 | INNOVATE MEDICAL, LLC | 1 | Y | 2026-01-01 | 2210 Buffalo Road Johnson City TN US 37604 |
| 3027939 | 1000142653 | INNOVATIVE MACHINERY PACKAGING AND CONVERTING INC. | 1 | N | 2026-01-01 | 1828 23rd St SE SALEM OR US 97302 |
| 8043867 | 3001126113 | INNOVATIVE EXCIMER SOLUTIONS, INC. | 1 | N | 2026-01-01 | 136 Sparks Avenue Toronto Ontario CA M2H 2S4 |
| 1000300091 | 1000300091 | INNOVATION SPECIALTIES | 1 | Y | 2026-01-01 | 11869 Teale St. Culver City CA US 90230 |
| 3003883240 | 3003883240 | Innovative(JiangYin) Electronics Co.,Ltd | 1 | N | 2026-01-01 | ShiZhuang PanLong Industrial Zone JiangYin Jiangsu CN 214445 |
| 3003974574 | 3003974574 | INNOVATIVE MEDICAL MANUFACTURING CO. | 1 | N | 2026-01-01 | No. 107, LN 181, SEC 1, Yongzhen Rd., Zhunan Township, Miaoli County TW 35057 |
| 3004202080 | 1000126788 | INNOVATIONS FOR ACCESS, INC. | 1 | N | 2026-01-01 | 8531 NE Cornell Rd STE 800, Hillsboro OR US 97124 |
| 3004524293 | 3004524293 | INNOVATIVE DISPOSABLES | 1 | N | 2026-01-01 | 3611 KENNEDY RD. SOUTH PLAINFIELD NJ US 07080 |
| 3004719693 | 3004719693 | INNOVASIS, INC. | 1 | Y | 2026-01-01 | 614 E 3900 S Millcreek UT US 84107 |
| 3005536872 | 3005536872 | INNOVATIVE INNOVATIONS INC. | 1 | Y | 2026-01-01 | 1132 Santa Ynez Ave. Henderson NV US 89002 |
| 3005694504 | 3005694504 | INNOVATIVE NEUROTRONICS INC. | 1 | N | 2026-01-01 | 1170 Trademark Dr Ste 104 Reno NV US 89521 |
| 3006119126 | 3006119126 | INNOVATIVE ORTHOPEDIC TECHNOLOGIES, LLC | 1 | Y | 2026-01-01 | 8708 S Congress Ave Ste A140 Austin TX US 78745 |
| 3006621310 | 3006621310 | INNOVATIVE MATERIAL & DEVICES, INC. | 1 | N | 2026-01-01 | Building 2, No. 345 Yanxin Rd., Huishan District Wuxi Jiangsu CN 214174 |
| 3007353136 | 3007353136 | INNOVATIVE MEDICAL EQUIPMENT | 1 | Y | 2026-01-01 | 23950 Commerce Park Suite 100 Beachwood OH US 44122 |
| 3008278641 | 3008278641 | INNOVATIVE PLASTICS | 1 | N | 2026-01-01 | 400 Route 303 Orangeburg NY US 10962 |
| 3008750913 | 3008750913 | INNOVACYN, INC. | 1 | N | 2026-01-01 | 3546 N Riverside Ave Rialto CA US 92377 |
| 3009436116 | 3009436116 | Innovatus Imaging Corporation | 1 | N | 2026-01-01 | 357 Inverness Dr. South, Suite C Englewood CO US 80112 |
| 3010060767 | 3010060767 | INNOVA PRODUCTS INC | 1 | Y | 2026-01-01 | 1289 Hammerwood Ave Sunnyvale CA US 94089 |
| 3010772758 | 3010772758 | INNOVATIVE STERILIZATION TECHN | 1 | N | 2026-01-01 | 7625 PARAGON RD STE A Dayton OH US 45459 |
| 3010933841 | 3010933841 | INNOVAQUARTZ LLC | 1 | N | 2026-01-01 | 23030 N 15TH AVE Phoenix AZ US 85027 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 53232 | 1647414525 | K972969 | QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM | GIO | 1997-09-22 |
| 44776 | 1666592161 | K962989 | AMOILS EPITHELIAL SCRUBBER | HOG | 1997-01-09 |
| 14004 | 1320305966 | K930431 | ARTHROSTIM MANIPULATOR | LXM | 1994-07-15 |
| 62623 | 1694489890 | K920614 | HEMO-BAND | KOC | 1992-07-27 |
| 345191 | 1847068774 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | OLO | 2025-07-23 |
| 345191 | 1693389590 | K250603 | AxTiHA® Stand-Alone ALIF System | OVD | 2025-03-24 |
| 345191 | 1958754840 | K250182 | Innovasis Navigation Instruments | OLO | 2025-03-24 |
| 345191 | 1111475987 | K250076 | Endeavor™ Stand-Alone Cervical IBF System | OVE | 2025-09-25 |
| 167626 | 1399491585 | K250029 | ONE TRAY® Sealed Sterilization Container System | KCT | 2025-05-01 |
| 345191 | 1900436749 | K241276 | Vector™ Pedicle Screw System | NKB | 2024-05-20 |
| 179362 | 1996958935 | K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | GEX | 2024-05-03 |
| 345191 | 1680976299 | K231899 | HAtetracell™-C Titanium Cervical IBF System | ODP | 2023-10-17 |
| 345191 | 1556113561 | K223511 | Excella Navigation Instruments | OLO | 2023-05-02 |
| 53232 | 1979940976 | K220458 | UltraFlo-R Push Button Blood Collection Set | JKA | 2023-09-29 |
| 167626 | 1471849828 | K213209 | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device | KCT | 2021-12-28 |
| 345191 | 2000078808 | K212967 | AxTiHA Stand-Alone ALIF System | OVD | 2021-10-15 |
| 167626 | 2045327613 | K211007 | EZ-TRAXTM Persona Knee Containment Device | KCT | 2021-07-01 |
| 167626 | 2053742543 | K202270 | EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device | KCT | 2020-12-02 |
| 345191 | 1869494358 | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | MAX | 2020-07-15 |
| 345191 | 1503982435 | K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | FST | 2020-06-30 |
| 167626 | 1029440269 | K192487 | EZ-TRAX Containment Device | KCT | 2019-12-23 |
| 345191 | 1724948665 | K192354 | Innovasis Gibralt Spine System | NKG | 2019-09-24 |
| 345191 | 1938270796 | K192049 | Oryx Cervical Plate System | KWQ | 2019-11-08 |
| 345191 | 1521391665 | K190684 | LxHA PEEK Lateral IBF System | MAX | 2019-06-17 |
| 345191 | 1064106451 | K181115 | CxHA PEEK Cervical IBF System | ODP | 2018-07-16 |
| 345191 | 1006216135 | K181063 | Kestrel™ Buttress Plate System | KWQ | 2018-07-13 |
| 179362 | 1853323079 | K180140 | ProFlex Laser Fibers | GEX | 2018-04-20 |
| 345191 | 1170191087 | K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | MAX | 2018-04-17 |
| 53232 | 1820479177 | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder | JKA | 2018-06-04 |
| 345191 | 1622747969 | K162236 | Ax Stand-Alone ALIF System | OVD | 2017-04-20 |
| 345191 | 1401369137 | K162143 | FixxSure® X-Link | MNH | 2016-09-23 |
| 137374 | 1878357723 | K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | IYN | 2016-08-18 |
| 137374 | 1149931375 | K152126 | UST-5550-R; UST-5536-R; L43K | ITX | 2016-08-17 |
| 345191 | 1008436755 | K151785 | Px HA PEEK IBF System | MAX | 2015-10-14 |
| 171907 | 2049785411 | K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula | FRO | 2015-11-19 |
| 345191 | 1640220748 | K150500 | Px PEEK IBF System | MAX | 2015-06-19 |
| 179362 | 1393204960 | K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | GEX | 2014-12-19 |
| 345191 | 1808470994 | K141644 | INNOVASIS CRANIAL SYSTEM | GWO | 2014-11-07 |
| 345191 | 2067509807 | K141452 | LEFORTE NEURO SYSTEM BONE PLATE AND SCREW | GWO | 2014-07-02 |
| 137374 | 1715784750 | K141440 | DICOMPACS DX-R WITH FLAT PANEL | MQB | 2014-08-29 |
| 24371 | 1994585203 | K140886 | WALKAIDE SYSTEM | GZI | 2014-08-08 |
| 345191 | 1397572978 | K140238 | EXCELLA III-D SPINAL DEFORMITY SYSTEM | NKB | 2014-05-07 |
| 171907 | 1868809480 | K133542 | PURACYN PLUS SKIN AND WOUND | FRO | 2014-04-28 |
| 345191 | 1117728687 | K133340 | SPINEWORKS ANTERIOR LUMBAR DEVICE | MAX | 2014-04-11 |
| 345191 | 1052529037 | K132991 | C-BOX PEEK CERVICAL IBF | ODP | 2014-02-12 |
| 137374 | 1318343968 | K130173 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | IYN | 2013-03-25 |
| 53232 | 1735209315 | K123987 | IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET | JKA | 2013-08-27 |
| 24371 | 1950863256 | K123972 | WALKAIDE SYSTEM | GZI | 2013-04-01 |
| 345191 | 2060020796 | K121581 | BOX PEEK VBR SYSTEM, | MAX | 2012-10-17 |
| 345191 | 1602812532 | K102248 | EXCELLA II SPINAL SYSTEM MODEL EC2-00 | NKB | 2010-10-07 |
| 345191 | 1480936055 | K101563 | SMARTO | KIJ | 2010-12-17 |
| 65547 | 1420023499 | K090727 | IMM DENTAL IRRIGATION TUBING SET | EBW | 2009-08-13 |
| 62623 | 1351576783 | K081740 | HEMOBAND, MODELS HB-NS AND HB-NSXL | KOC | 2009-03-12 |
| 345191 | 1763002799 | K081331 | FIXXSURE CROSS LINK | MNH | 2008-07-23 |
| 345191 | 1732863824 | K071921 | INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) | NKB | 2007-11-16 |
| 65547 | 1873266688 | K070801 | IMM HYPODERMIC NEEDLE SET | FPA | 2007-05-24 |
| 345191 | 1640981996 | K062151 | BOX PEEK VBR SYSTEM | MQP | 2006-12-22 |
| 345191 | 2051815213 | K061147 | OPTERYX ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2006-06-30 |
| 167626 | 1816791561 | K052567 | ONE TRAY SEALED STERILIZATION CONTAINER | KCT | 2006-03-13 |
| 24371 | 1769076113 | K052329 | WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 | GZI | 2005-09-21 |
| 66104 | 1204985808 | K051021 | ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A | DXQ | 2005-06-20 |
| 179362 | 1781744502 | K050412 | VAPORMAX | GEX | 2005-03-14 |
| 345191 | 1208999763 | K042600 | STANSION MATRIX | MQP | 2005-02-18 |
| 345191 | 1581174078 | K042143 | EXCELLA-M SPINAL SYSTEM | KWP | 2004-10-07 |
| 66104 | 1515881334 | K041694 | DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER | FLL | 2004-09-13 |
| 66104 | 1660718672 | K041693 | WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES | DXN | 2004-12-02 |
| 66104 | 1772537514 | K041692 | INFRARED EAR THERMOMETER, ET-100 SERIES | FLL | 2004-09-13 |
| 137374 | 1326108143 | K040719 | ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY | IYO | 2004-03-26 |
| 100900 | 1845242781 | K032150 | SAFETY-MULTIFLY | FPA | 2003-09-12 |
| 14004 | 1102799529 | ||||
| 100900 | 1182015751 | ||||
| 100900 | 1261895150 | ||||
| 252617 | 1361635560 | ||||
| 100900 | 1410143724 | ||||
| 67871 | 1642696832 | ||||
| 44776 | 1716429409 | ||||
| 100900 | 1744758612 | ||||
| 67871 | 1850314036 | ||||
| 67871 | 1897630519 | ||||
| 100900 | 1948244254 | ||||
| 67871 | 1952434161 | ||||
| 53232 | 1957700688 | ||||
| 67871 | 2064978434 | ||||
| 65547 | 1004754715 | ||||
| 46230 | 1018820255 | ||||
| 67871 | 1042700418 | ||||
| 66104 | 1064352386 | ||||
| 65547 | 1096185302 | ||||
| 25709 | 1122183389 | ||||
| 252617 | 1127009144 | ||||
| 75729 | 1132518615 | ||||
| 46230 | 1137354780 | ||||
| 25709 | 1145280781 | ||||
| 100900 | 1156534458 | ||||
| 65547 | 1157108955 | ||||
| 25709 | 1160708799 | ||||
| 94677 | 1176707023 | ||||
| 46230 | 1190732219 | ||||
| 46230 | 1197057435 | ||||
| 46230 | 1219815822 | ||||
| 24371 | 1229021717 | ||||
| 65547 | 1243934393 | ||||
| 46230 | 1259055679 | ||||
| 46230 | 1260945409 | ||||
| 67871 | 1262810012 | ||||
| 65547 | 1274232879 | ||||
| 25709 | 1299298813 | ||||
| 100900 | 1319365703 | ||||
| 65547 | 1343120459 | ||||
| 137374 | 1377090433 | ||||
| 65547 | 1387158739 | ||||
| 65547 | 1393413056 | ||||
| 66104 | 1398137150 | ||||
| 65547 | 1406319445 | ||||
| 25709 | 1409704163 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KCT | 7 | 2025-05-01 |
| MAX | 7 | 2020-07-15 |
| GEX | 6 | 2024-05-03 |
| NKB | 4 | 2024-05-20 |
| OLO | 3 | 2025-07-23 |
| OVD | 3 | 2025-03-24 |
| ODP | 3 | 2023-10-17 |
| JKA | 3 | 2023-09-29 |
| KWQ | 3 | 2019-11-08 |
| GZI | 3 | 2014-08-08 |
| MNH | 2 | 2016-09-23 |
| IYN | 2 | 2016-08-18 |
| FRO | 2 | 2015-11-19 |
| GWO | 2 | 2014-11-07 |
| KOC | 2 | 2009-03-12 |
| FPA | 2 | 2007-05-24 |
| MQP | 2 | 2006-12-22 |
| FLL | 2 | 2004-09-13 |
| OVE | 1 | 2025-09-25 |
| FST | 1 | 2020-06-30 |
| NKG | 1 | 2019-09-24 |
| ITX | 1 | 2016-08-17 |
| MQB | 1 | 2014-08-29 |
| KIJ | 1 | 2010-12-17 |
| EBW | 1 | 2009-08-13 |
| DXQ | 1 | 2005-06-20 |
| DXN | 1 | 2004-12-02 |
| KWP | 1 | 2004-10-07 |
| IYO | 1 | 2004-03-26 |
| GIO | 1 | 1997-09-22 |
| HOG | 1 | 1997-01-09 |
| LXM | 1 | 1994-07-15 |
Ethyl Alcohol
Ethyl Alcohol
Benzethonium Chloride
Benzalkonium Chloride
Alcohol
Ethyl Alcohol
Ethyl Alcohol
Hand Sanitizing Wipes
zinc oxide
zinc oxide
MENTHOL
MENTHOL
Octinoxate, Homosalate, Octisalate, Oxybenzone and Avobenzone
Octinoxate, Homosalate, Octisalate, Oxybenzone and Avobenzone
Octinoxate, Homosalate, Octisalate, Oxybenzone and Avobenzone
Octinoxate, Homosalate, Octisilate, Oxybenzone and Avobenzone
Octinoxate, Homosalate, Octisalate, Oxybenzone, Avobenzone
Octinoxate, Homosalate, Octisalate, Oxybenzone and Avobenzone
Octinoxate, Homosalate, Octisalate, Oxybenzone and Avobenzone
Octinoxate, Homosalate, Octisalate, Oxybenzone, Avobenzone
Octinoxate, Homosalate, Octisalate, Oxybenzone and Avobenzone
Octinoxate, Homosalate, Octisalate, Oxybenzone and Avobenzone
Octinoxate, Homosalate, Octisilate, Oxybenzone and Avobenzone
Octinoxate, Homosalate, Octisilate, Oxybenzone and Avobenzone
Purified Water
Water
Zinc Oxide
Ethyl alcohol
Ethyl alcohol
Ethyl Alcohol
Ethyl alcohol
Ethyl Alcohol
Ethyl Alcohol
Ethyl alcohol
Ethyl alcohol
Ethyl alcohol
ETHYL ALCOHOL
Avobenzone, Homosalate, Octocrylene, Octisalate
Avobenzone, Homosalate, Octocrylene, Octisalate
Avobenzone, Homosalate, Octocrylene, Octisalate
INNOVATIVE MEDICAL SYSTEMS, INC.
INNOVATIVE MEDICAL SYSTEMS, INC.
INNOVATIVE MEDICAL SYSTEMS, INC.
INNOVATIVE MEDICAL SYSTEMS, INC.
INNOVATIVE MEDICAL SYSTEMS, INC.
INNOVATIVE MEDICAL SYSTEMS, INC.
Innovative Health, LLC
Innovative Health
Innovacyn, Inc.
Innovasis, Inc.
Innovaquartz, LLC
Innova Vision, Inc.
Innovative Health, LLC
Innovative Health Sciences, LLC
Innova Vision, Inc.
Innovasis, Inc.
Innovative Medical Technologies, Inc.
Innovative Health Technologies (Nz), Ltd.
Innovate Orthopaedics Limited
Innovative Health, LLC
Innova Vascular, Inc.
Innovative Bioceramix, Inc.
Innovasis, Inc.
Innovative Product Brands, Inc.
Innovative Health, LLC
Innova Vision, Inc.
Innovasis, Inc.
Innovative BioCeramix Inc.
Innovative Surgical Designs, Inc.
Innovasis, Inc.
Innovative Health, LLC.
Innovative Product Brands, Inc.
Innovative Health, LLC.
Innova Vision Inc.
Innovative Health, LLC.
Innovative Surgical Designs, Inc.
Innovate Orthopaedics Limited
Innovative Health, LLC
Innovative Health, LLC.
Innovasis, Inc.
Innovaquartz, LLC
Innovative Health, LLC.
Innovative Health Sciences, LLC
Innovative Surgical Designs, Inc.
Innovative Health, LLC
Innovative Health, LLC.
2026-03-31
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