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Data / Medical devices / United States / American Medical Endoscopy

American Medical Endoscopy: FDA-registered device maker in Doral, FL, United States, 20 510(k) clearances

American Medical Endoscopy is registered with the FDA (registration 3004361445) in Doral, FL, United States. It lists 33 device types. The FDA files 20 510(k) clearances under its listings, the newest dated June 4, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch American Medical Endoscopy
FDA registration number
3004361445
Address
3020 NW 82ND Ave., Doral, FL, United States, 33122
Owner or operator
American Medical Endoscopy (9059843)
Roles
Repackager or relabeler, Specification developer
First device listed
December 31, 2013
Registered through
2026
Brand names listed
Strauss Surgical, Strauss Surgical Cystoscopes & Hysteroscopes, Strauss Surgical cystoscope, hysteroscope and accessories Instruments

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Repackager or relabeler, Specification developeraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Repackager or relabeleraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Repackager or relabeler, Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Repackager or relabeleraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Repackager or relabeler, Specification developeraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Repackager or relabeleraccessdata.fda.gov
Illuminator, Fiberoptic, Surgical FieldHBI2Repackager or relabeleraccessdata.fda.gov
Image, Illumination, Fiberoptic, For Endoscope FFS2Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Repackager or relabeleraccessdata.fda.gov
Kit, NephroscopeFGA2Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Repackager or relabeleraccessdata.fda.gov
Lithotriptor, Biliary MechanicalLQC2Repackager or relabeleraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Repackager or relabeleraccessdata.fda.gov
Needle, Gastro-UrologyFHR1Repackager or relabeleraccessdata.fda.gov
Obturator, For EndoscopeFEC2Repackager or relabeleraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Repackager or relabeleraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Repackager or relabeleraccessdata.fda.gov
Retractor, Self-RetainingFFO1Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Trocar, Gastro-UrologyFBQ2Repackager or relabeleraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Repackager or relabeleraccessdata.fda.gov
UrethrotomeEZO2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 4, 2026K253020Strauss Surgical Resection InstrumentsHIHSubstantially EquivalentAmerican Medical Endoscopy, Inc.accessdata.fda.gov
March 27, 2026K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsFAJSubstantially EquivalentAmerican Medical Endoscopy, Inc.accessdata.fda.gov
August 1, 2025K251652Strauss 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-endoFAJSubstantially EquivalentAmerican Medical Endoscopy, Inc.accessdata.fda.gov
April 2, 2021K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableGEXSubstantially EquivalentLeoni Fiber Optics, Inc.accessdata.fda.gov
June 8, 2018K173070HSW Resection InstrumentsHIHSubstantially EquivalentHenke-Sass, Wolf GmbHaccessdata.fda.gov
December 7, 2017K171336Cystoscope 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 SheathFAJSubstantially EquivalentHenke-Sass, Wolf GmbHaccessdata.fda.gov
August 22, 2017K171523Monopolar Single Use Laparoscopic InstrumentGEISubstantially EquivalentGetsch+Hiller Medizintechnik GmbHaccessdata.fda.gov
February 9, 2016K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetFGASubstantially EquivalentSchoelly Fiberoptic GmbHaccessdata.fda.gov
March 9, 2015K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIHSubstantially EquivalentSchoelly Fiberoptic GmbHaccessdata.fda.gov
December 5, 2014K143221Schoelly LaparoscopeGCJSubstantially EquivalentSchoelly Fiberoptic GmbHaccessdata.fda.gov
June 2, 2014K133682SCHOELLY ARTHROSCOPEHRXSubstantially EquivalentScholly Fiberoptic GmbHaccessdata.fda.gov
March 1, 2011K091010TROKAMED MORCELLATORHETSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
January 16, 2009K083553NASO-LARYNGO-PHARYNGOSCOPEEOBSubstantially EquivalentSchoelly Imaging, Inc.accessdata.fda.gov
March 2, 2007K060899FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPEFAJSubstantially EquivalentSchoelly Imaging, Inc.accessdata.fda.gov
July 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
July 12, 2006K060232TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIESGEISubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
September 6, 2002K021931ENDOSCOPIC FIBEROPTIC CABLEHBISubstantially EquivalentGulf Medical Fiberopticsaccessdata.fda.gov
October 13, 1999K992527URETERO-RENOSCOPEFGBSubstantially EquivalentFiber Imaging Technologies, Inc.accessdata.fda.gov
September 14, 1999K992437SCHOELLY RIGID ENDOSCOPESGCJSubstantially EquivalentFiber Imaging Technologies, Inc.accessdata.fda.gov
August 6, 1999K992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESHRXSubstantially EquivalentFiber Imaging Technologies, Inc.accessdata.fda.gov

Compare with other makers

Updated June 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.