AMERICAN MEDICAL ENDOSCOPY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30043614453004361445AMERICAN MEDICAL ENDOSCOPY1Y2026-01-013020 NW 82ND AVE. Doral FL US 33122

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
760951623744646K992527URETERO-RENOSCOPEFGB1999-10-13
760951809466156K992437SCHOELLY RIGID ENDOSCOPESGCJ1999-09-14
760951499867734K992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESHRX1999-08-06
760951167258249K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsFAJ2026-03-27
760951293996470K251652Strauss 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-endoFAJ2025-08-01
760951261576514K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableGEX2021-04-02
760951405291890K173070HSW Resection InstrumentsHIH2018-06-08
760951536624498K171523Monopolar Single Use Laparoscopic InstrumentGEI2017-08-22
760951671792095K171336Cystoscope 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 SheathFAJ2017-12-07
760951243082137K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetFGA2016-02-09
760951171436441K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH2015-03-09
760951794903226K143221Schoelly LaparoscopeGCJ2014-12-05
760951983137700K133682SCHOELLY ARTHROSCOPEHRX2014-06-02
760951621387591K091010TROKAMED MORCELLATORHET2011-03-01
760951059036825K083553NASO-LARYNGO-PHARYNGOSCOPEEOB2009-01-16
760951848067009K060899FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPEFAJ2007-03-02
760951669998863K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJ2006-07-19
760951454517229K060232TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIESGEI2006-07-12
760951806129297K021931ENDOSCOPIC FIBEROPTIC CABLEHBI2002-09-06
760951011194756
760951066743441
760951157792830
760951219445486
760951231232077
760951262671862
760951415039042
760951415599504
760951495710042
760951539714761
760951644577877
760951691300054
760951691544867
760951720590507
760951726040058
760951835550674
760951980140168
760951981219087
760951999153310

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FAJ42026-03-27
GCJ32014-12-05
HIH22018-06-08
GEI22017-08-22
HRX22014-06-02
GEX12021-04-02
FGA12016-02-09
HET12011-03-01
EOB12009-01-16
HBI12002-09-06
FGB11999-10-13

GUDID#

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