Candee Caine Topical Anesthetic
Benzocaine
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004361445 | 3004361445 | AMERICAN MEDICAL ENDOSCOPY | 1 | Y | 2026-01-01 | 3020 NW 82ND AVE. Doral FL US 33122 |
| 3004552850 | 3004552850 | AMERICAN MEDICALS | 1 | Y | 2026-01-01 | 8900 Corporate Square Ct Jacksonville FL US 32216 |
| 3008364966 | 3008364966 | AMERICAN MEDICAL PRODUCTS LLC | 1 | Y | 2026-01-01 | 151 Industrial Way East Eatontown NJ US 07724 |
| 3014732877 | 3014732877 | AMERICAN MEDICAL WAREHOUSE, INC. | 1 | Y | 2026-01-01 | 2635 ARDOR LANE Orange City FL US 32763 |
| 2084960 | 1000135819 | AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. | 1 | Y | 2020-04-25 | 28703 INDUSTRY DR Valencia CA US 91355 |
| 2183959 | 1000116179 | American Medical Systems, Inc. | 1 | N | 2020-04-25 | 10700 BREN ROAD WEST Minnetonka MN US 55343 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 186598 | 1294619430 | P000053 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | EZY | 2001-06-14 |
| 186598 | 1442909449 | N970012 | AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES | JCW | 1998-11-02 |
| 76095 | 1623744646 | K992527 | URETERO-RENOSCOPE | FGB | 1999-10-13 |
| 76095 | 1809466156 | K992437 | SCHOELLY RIGID ENDOSCOPES | GCJ | 1999-09-14 |
| 76095 | 1499867734 | K992040 | FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES | HRX | 1999-08-06 |
| 76095 | 1167258249 | K260271 | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | FAJ | 2026-03-27 |
| 76095 | 1293996470 | K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo | FAJ | 2025-08-01 |
| 76095 | 1261576514 | K201171 | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable | GEX | 2021-04-02 |
| 76095 | 1405291890 | K173070 | HSW Resection Instruments | HIH | 2018-06-08 |
| 76095 | 1536624498 | K171523 | Monopolar Single Use Laparoscopic Instrument | GEI | 2017-08-22 |
| 76095 | 1671792095 | K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath | FAJ | 2017-12-07 |
| 22858 | 1367957294 | K160802 | Infrared Forehead Thermometer, FT-100A | FLL | 2016-08-24 |
| 76095 | 1243082137 | K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | FGA | 2016-02-09 |
| 76095 | 1171436441 | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | HIH | 2015-03-09 |
| 76095 | 1794903226 | K143221 | Schoelly Laparoscope | GCJ | 2014-12-05 |
| 76095 | 1983137700 | K133682 | SCHOELLY ARTHROSCOPE | HRX | 2014-06-02 |
| 76095 | 1621387591 | K091010 | TROKAMED MORCELLATOR | HET | 2011-03-01 |
| 186598 | 1758669446 | K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | FAE | 2009-04-09 |
| 76095 | 1059036825 | K083553 | NASO-LARYNGO-PHARYNGOSCOPE | EOB | 2009-01-16 |
| 76095 | 1848067009 | K060899 | FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE | FAJ | 2007-03-02 |
| 76095 | 1669998863 | K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | GCJ | 2006-07-19 |
| 76095 | 1454517229 | K060232 | TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES | GEI | 2006-07-12 |
| 186598 | 1104446946 | K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM | OTM | 2006-02-03 |
| 76095 | 1806129297 | K021931 | ENDOSCOPIC FIBEROPTIC CABLE | HBI | 2002-09-06 |
| 22858 | 1074339067 | ||||
| 22858 | 1148980599 | ||||
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| 22858 | 1989225345 | ||||
| 186598 | 2045997532 | ||||
| 22858 | 1003842124 | ||||
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| 22858 | 1745731177 | ||||
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| 22858 | 1813302020 | ||||
| 76095 | 1835550674 | ||||
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| 76095 | 1980140168 | ||||
| 76095 | 1981219087 | ||||
| 116109 | 1986558055 | ||||
| 76095 | 1999153310 | ||||
| 22858 | 2064006206 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FAJ | 4 | 2026-03-27 |
| GCJ | 3 | 2014-12-05 |
| HIH | 2 | 2018-06-08 |
| GEI | 2 | 2017-08-22 |
| HRX | 2 | 2014-06-02 |
| GEX | 1 | 2021-04-02 |
| FLL | 1 | 2016-08-24 |
| FGA | 1 | 2016-02-09 |
| HET | 1 | 2011-03-01 |
| FAE | 1 | 2009-04-09 |
| EOB | 1 | 2009-01-16 |
| OTM | 1 | 2006-02-03 |
| HBI | 1 | 2002-09-06 |
| EZY | 1 | 2001-06-14 |
| FGB | 1 | 1999-10-13 |
| JCW | 1 | 1998-11-02 |
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Oxygen
Oxygen
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED
AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
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AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
AMERICAN MEDICAL SYSTEMS, INC.
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