Indocyanine Green
Indocyanine Green and Water
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3034520 | 3003350313 | RENU MEDICAL, INC. | 1 | N | 2026-01-01 | 5900 36th Ave W Ste 100 EVERETT WA US 98203 |
| 3007842555 | 3007842555 | Renee Rees | 1 | N | 2026-01-01 | 35 Constitution Drive, Suite 1D Bedford NH US 03110 |
| 3008190709 | 3008190709 | Renfro LLC | 1 | N | 2026-01-01 | 4405 Michigan Avenue Rd NE Cleveland TN US 37323 |
| 3008840959 | 3008840959 | Renee Rees | 1 | N | 2026-01-01 | 35 Constitution Drive, Suite 1D Bedford NH US 03110 |
| 3009108888 | 3009108888 | RENISHAW MAYFIELD | 1 | N | 2026-01-01 | 31 rue Ampere Chassieu Rhone FR 69680 |
| 3009118264 | 3009118264 | Renee Rees | 1 | N | 2026-01-01 | 35 Constitution Drive, Suite 1D Bedford NH US 03110 |
| 3009218271 | 3009218271 | Renee Rees | 1 | N | 2026-01-01 | 35 Constitution Drive, Suite 1D Bedford NH US 03110 |
| 3009233038 | 3009233038 | Renee Rees | 1 | N | 2026-01-01 | 35 Constitution Drive, Suite 1D Bedford NH US 03110 |
| 3009496643 | 3009496643 | Renee Rees | 1 | N | 2026-01-01 | 35 Constitution Drive, Suite 1D Bedford NH US 03110 |
| 3011279674 | 3011279674 | RENOVORX, INC. | 1 | N | 2026-01-01 | 2570 W El Camino Suite 320 Mountain View CA US 94040 |
| 3011543740 | 3011543740 | Rene van de Zande | 1 | N | 2026-01-01 | 10900 Research Blvd Ste 160c Pmb 2066 Austin TX US 78759 |
| 3012254343 | 3012254343 | RENISHAW HEALTHCARE INC | 1 | Y | 2026-01-01 | 1001 wesemann dr. West Dundee IL US 60118 |
| 3013588740 | 3013588740 | Renee Zamani | 1 | N | 2026-01-01 | 2196 3rd Ave # 1004 New York NY US 10035 |
| 3013956081 | 3013956081 | RENEE'S READERS | 1 | N | 2026-01-01 | 18 Sandusky Road New City NY US 10956 |
| 3014023545 | 3014023545 | RENOVO, INC. | 1 | N | 2026-01-01 | 340 SW COLUMBIA ST Bend OR US 97702 |
| 3018739912 | 3018739912 | RENALYTIXAI | 1 | N | 2026-01-01 | 30-02 48th Avenue Suite 150 Long Island City NY US 11101 |
| 3018799047 | 3018799047 | RENEWMEDICAL CO., LTD. | 1 | N | 2026-01-01 | 28-7, Jeongju-ro Bucheon-si, Gyeonggi-do KR 14532 |
| 3022317591 | 3022317591 | RENERVE LTD | 1 | N | 2026-01-01 | L 10 99 Queen Street Melbourne Victoria AU 3000 |
| 3027098402 | 3027098402 | RENATA MEDICAL | 1 | N | 2026-01-01 | 4675 Macarthur Ct Ste 1150 Newport Beach CA US 92660 |
| 3027241826 | 3027241826 | RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V. | 1 | N | 2026-01-01 | Carretera a los Cues K.M. 2.2, Lote 23 Bodegas 5 y 6. El Marques Queretaro MX 76246 |
| 3027978412 | 3027978412 | RENOLIT HANSEN PACKAGING TECH. (BJ) LTD. | 1 | N | 2026-01-01 | NO.22 Yanqi Street, Huairou Economic Development District Beijing CN 101407 |
| 3042928350 | 3042928350 | Rene Balzano | 1 | N | 2026-01-01 | 610 E Zack St Ste 110-3058 Tampa FL US 33602 |
| 0 | 0 | Renlin Li | 5 | N | 2020-04-25 | 11300 Rockville Pike, Suite 715, Rockville Rockville MD US 20852 |
| 9615020 | 3002739972 | Renee Bennett | 1 | N | 2020-04-25 | 3050 East Hillcrest Drive Thousand Oaks CA US 91362 |
| 9616379 | 3003572251 | Rene van de Zande | 1 | N | 2020-04-25 | 2500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 331175 | 1236501368 | P240003 | Minima Stent System | PNF | 2024-08-28 |
| 133645 | 1711364071 | K250496 | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | LZA | 2025-07-07 |
| 347019 | 1058829504 | K242607 | ScanDiags Ortho L-Spine MR-Q | QIH | 2025-02-21 |
| 130957 | 1316948092 | K222815 | Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl | LZA | 2022-12-04 |
| 135295 | 1993909595 | K222815 | Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl | LZA | 2022-12-04 |
| 135295 | 1016751991 | K222074 | Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves | LZA | 2022-10-17 |
| 107431 | 2003350353 | K222074 | Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves | LZA | 2022-10-17 |
| 316586 | 1204198756 | K221652 | NIKKICART | KPO | 2023-03-03 |
| 135295 | 1300019120 | K212998 | Powder Free Nitrile Examination Gloves (White, Blue and Black) | LZA | 2022-02-19 |
| 176448 | 1152227410 | K212324 | RenovoCath | MJN | 2021-08-23 |
| 59242 | 1040042785 | K203847 | Reprocessed Tri Pulse Compression Garment | JOW | 2021-05-07 |
| 304388 | 1626090135 | K202234 | NervAlign Nerve Cuff | JXI | 2022-02-10 |
| 176448 | 1699725477 | K191606 | RenovoCath | MJN | 2019-08-07 |
| 130957 | 1143182067 | K182640 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | LZA | 2019-04-12 |
| 122988 | 1145548872 | K182640 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | LZA | 2019-04-12 |
| 173276 | 1973782716 | K181706 | neuromate Gen III | HAW | 2018-07-26 |
| 211427 | 2030138206 | K173741 | Reprocessed ArthoCare Ablation Wand | NUJ | 2018-03-05 |
| 211427 | 1143477685 | K173740 | Reprocessed DePuy Mitek Ablation Wand | NUJ | 2018-03-19 |
| 211427 | 1178649201 | K172647 | Reprocessed ArthroCare ENT Coblator | NUJ | 2018-02-21 |
| 211427 | 1352726919 | K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves | NLM | 2017-10-06 |
| 211427 | 1422744499 | K172093 | Reprocessed Covidien Trocar | NLM | 2017-10-05 |
| 211427 | 1579470534 | K172092 | Reprocessed Shavers/Burs | HRX | 2017-10-04 |
| 176448 | 1191421130 | K141175 | RENOVOCATH RC120 | MJN | 2014-10-24 |
| 173276 | 1577191138 | K132755 | NEUROMATE FRAMELESS GEN II | HAW | 2014-04-29 |
| 59242 | 1323679103 | K121145 | RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME | JOW | 2012-06-12 |
| 135295 | 1066229750 | K112222 | ALCATRON AND / OR MULTIPLE BRAND | LYZ | 2011-10-27 |
| 133645 | 1548787294 | K111857 | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE | LYZ | 2011-09-21 |
| 59242 | 1728001450 | K111773 | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | NLF | 2011-11-16 |
| 130957 | 1303738268 | K111297 | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) | LYZ | 2011-06-16 |
| 107431 | 1108729753 | K110621 | SHENGKUN CHEMICAL | LYZ | 2011-08-24 |
| 133645 | 1941804333 | K110621 | SHENGKUN CHEMICAL | LYZ | 2011-08-24 |
| 136304 | 1211118126 | K110314 | STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED) | LYZ | 2011-05-10 |
| 122988 | 1366750331 | K102337 | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE | LYZ | 2010-11-08 |
| 59242 | 1152544767 | K093658 | RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS | JOW | 2010-01-14 |
| 107431 | 1067616166 | K091422 | NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) | LYZ | 2009-07-30 |
| 107431 | 1458178969 | K091421 | NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) | LYZ | 2009-07-23 |
| 136304 | 1864458420 | K090513 | VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) | LYZ | 2009-05-08 |
| 59242 | 1899155459 | K081927 | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | NLF | 2009-02-06 |
| 59242 | 1701948783 | K072194 | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | NLF | 2007-11-29 |
| 59242 | 1016884366 | K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | NLF | 2007-05-25 |
| 59242 | 1135766100 | K051227 | RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 | JOW | 2006-04-07 |
| 100552 | 1332426069 | K050260 | BIORESORB MACRO PORE | LYC | 2005-07-15 |
| 59242 | 1351628016 | K031559 | RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES | JOW | 2003-11-12 |
| 291661 | 2068803454 | DEN200052 | KidneyIntelX.dkd | QWZ | 2023-06-29 |
| 211427 | 1009610732 | ||||
| 211427 | 1041288751 | ||||
| 15969 | 1073297976 | ||||
| 211427 | 1089112145 | ||||
| 59242 | 1120517088 | ||||
| 224681 | 1159957307 | ||||
| 253342 | 1163946638 | ||||
| 211427 | 1174879093 | ||||
| 211427 | 1283042776 | ||||
| 211427 | 1286368290 | ||||
| 211427 | 1300566526 | ||||
| 211427 | 1310257243 | ||||
| 211427 | 1458366982 | ||||
| 211427 | 1512021555 | ||||
| 15969 | 1641048900 | ||||
| 211427 | 1656377002 | ||||
| 15969 | 1734149868 | ||||
| 253342 | 1821192285 | ||||
| 15969 | 1823200394 | ||||
| 224681 | 1902977881 | ||||
| 211427 | 1940972182 | ||||
| 211427 | 1949911859 | ||||
| 59242 | 1963830973 | ||||
| 211427 | 1990449278 | ||||
| 211427 | 2001390664 | ||||
| 211427 | 2019111218 | ||||
| 211427 | 2065748036 | ||||
| 211427 | 1025423461 | ||||
| 136304 | 1059535998 | ||||
| 133645 | 1080417428 | ||||
| 59242 | 1097889985 | ||||
| 210428 | 1227439517 | ||||
| 334266 | 1267865244 | ||||
| 211427 | 1268274762 | ||||
| 210428 | 1319530768 | ||||
| 210428 | 1396088381 | ||||
| 211427 | 1430026738 | ||||
| 59242 | 1458284312 | ||||
| 152588 | 1459656402 | ||||
| 210428 | 1460443772 | ||||
| 136304 | 1475619440 | ||||
| 210428 | 1481683553 | ||||
| 211427 | 1487573219 | ||||
| 59242 | 1495245498 | ||||
| 224681 | 1499238761 | ||||
| 210428 | 1506407923 | ||||
| 59242 | 1525453637 | ||||
| 210428 | 1572490222 | ||||
| 136304 | 1615551374 | ||||
| 334266 | 1628940068 | ||||
| 136304 | 1628989903 | ||||
| 136304 | 1637925782 | ||||
| 136304 | 1638601735 | ||||
| 291661 | 1663894825 | ||||
| 136304 | 1671860507 | ||||
| 136304 | 1676737613 | ||||
| 211427 | 1751585133 | ||||
| 210428 | 1755443755 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LYZ | 10 | 2011-10-27 |
| LZA | 8 | 2025-07-07 |
| NUJ | 6 | 2018-03-19 |
| JOW | 5 | 2021-05-07 |
| NLM | 4 | 2017-10-06 |
| NLF | 4 | 2011-11-16 |
| MJN | 3 | 2021-08-23 |
| HAW | 2 | 2018-07-26 |
| HRX | 2 | 2017-10-04 |
| QIH | 1 | 2025-02-21 |
| QWZ | 1 | 2023-06-29 |
| KPO | 1 | 2023-03-03 |
| JXI | 1 | 2022-02-10 |
| LYC | 1 | 2005-07-15 |
Indocyanine Green and Water
Indocyanine Green
Indocyanine Green
MENTHOL
tolnaftate
ZINC OXIDE
Tolnaftate serum
Tolnaftate Oil
Zinc Cream
Menthol, Methyl Salicylate
Acne Sulfur Lotion
Menthol, Methyl Salicylate
Menthol
Menthol
Menthol
Colloidal Oatmeal, Dimethicone
Hydrocortisone
Lidocaine HCI
ZINC OXIDE
ZINC SPF
Zinc Oxide
Lidocaine Emulsion
Lidocaine 3 percent
Hydrocortisone
MENTHOL
Zinc Oxide 10%
Lidocaine 3 percent
Menthol Roll On
Lidocaine HCl
Menthol
Avobenzone,Homosalate,Octisalate
Avobenzone,Homosalate,Octisalate
CUPRIC CHLORIDE
Dimethyl Sulfoxide
L-glutamine
Ascorbic Acid
Renal Care Dialysis Solutions, S.A. DE C.V.
Renovia Inc.
Renerve Ltd
Renovia Inc.
Renovorx, Inc.
RenalPro Medical, Inc.
RENU Medical, Inc
Renovia Inc.
RenovoRx, Inc.
Renovis Surgical Technologies
Renovis Surgical Technologies
Renovis Surgical Technologies
Renishaw Mayfield Sarl
Renovis Surgical Technologies Inc.
Renishaw Mayfield Sarl
Renovia Inc.
ReNovo, Inc.
ReNovo, Inc.
ReNovo, Inc.
Renovis Surgical Technologies
Renovo, Inc.
Renovo, Inc.
Renovo, Inc.
Rensihaw Plc
Renovis Surgical Technologies
Reno Medical Ltd.
RenovoRx, Inc.
Renovo Life LLC
RENOVIS SURGICAL TECHNOLOGIES
Renovo Life LLC
Renovis Surgical Technologies, Inc.
Renovis Surgical Technologies, Inc.
Renovis Surgical Technologies
Renovis Surgical Technologies, Inc.
RENOVORX, INC.
Renovis Surgical Technologies, Inc.
Renovis Surgical Technologies, Inc.
RENISHAW MAYFIELD SARL
RENOVIS SURGICAL TECHNOLOGIES, LLC
Renovis Surgical Technologies, Inc.