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Data / Medical devices / United States / Dornier Medtech America, Inc.

Dornier Medtech America, Inc.: FDA-registered device maker in Kennesaw, GA, United States, 30 510(k) clearances

Dornier Medtech America, Inc. is registered with the FDA (registration 1037955) in Kennesaw, GA, United States. It lists 19 device types. The FDA files 30 510(k) clearances under its listings, the newest dated January 29, 2026. 1 recall event names it as the recalling firm. 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 Dornier Medtech America, Inc.
FDA registration number
1037955
Address
1155 Roberts BLVD., Kennesaw, GA, United States, 30144
Owner or operator
Dornier MedTech America, Inc. (1037955)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
October 26, 1992
Registered through
2026
Brand names listed
DORNIER MEDILAS H, Dornier MedTech America, Inc. MAGELLAN Access Sheath, Medilas H Ball Tip Laser Fiber, Medilas H RFID Laser Fiber, Medilas H RFID Laser Fibers, Medilas H Slim Laser Fiber, Medilas H Solvo 35 Laser, Nautilus and more

Devices it lists

DeviceProduct codeClassRoleSource
Bottle, Collection, VacuumKDQ2Complaint file establishmentaccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Complaint file establishmentaccessdata.fda.gov
Catheter, Ureteral, Gastro-UrologyEYB2Specification developeraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Complaint file establishmentaccessdata.fda.gov
Dilator, Catheter, UreteralEZN2Specification developeraccessdata.fda.gov
Dilator, UrethralKOE2Specification developeraccessdata.fda.gov
Dislodger, Stone, FlexibleFGO2Complaint file establishmentaccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Complaint file establishment, Specification developeraccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Complaint file establishment, Specification developeraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Complaint file establishmentaccessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2Complaint file establishmentaccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Complaint file establishmentaccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Complaint file establishmentaccessdata.fda.gov
Lithotriptor, Extracorporeal Shock-Wave, UrologicalLNS2Complaint file establishmentaccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Complaint file establishment, Manufactureraccessdata.fda.gov
Stent, UreteralFAD2Specification developeraccessdata.fda.gov
Stylet, UreteralEYA1Complaint file establishmentaccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Complaint file establishmentaccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Complaint file establishmentaccessdata.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
January 29, 2026K251923Medical Shaver System (Morcellator) (YSB-IIIA)GCJSubstantially EquivalentHangzhou Hawk Optical Electronic Instruments Co., Ltd.accessdata.fda.gov
December 5, 2025K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )FASSubstantially EquivalentDornier Medtech America Inc (Dmta)accessdata.fda.gov
November 24, 2025K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)GEXSubstantially EquivalentGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.accessdata.fda.gov
November 24, 2025K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)GEXSubstantially EquivalentGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.accessdata.fda.gov
October 3, 2025K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)FGBSubstantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.accessdata.fda.gov
May 29, 2025K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28USEOQSubstantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.accessdata.fda.gov
April 11, 2025K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)FGBSubstantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.accessdata.fda.gov
January 31, 2025K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250FEDSubstantially EquivalentDornier Medtech Americaaccessdata.fda.gov
June 26, 2024K233380TRIDENT Mobile Fluoroscopy SystemJAASubstantially EquivalentDornier Medtech Americaaccessdata.fda.gov
February 22, 2023K221903Delta III ProLNSSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
November 9, 2022K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJSubstantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.accessdata.fda.gov
October 5, 2022K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)FGBSubstantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.accessdata.fda.gov
August 26, 2022K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)FGBSubstantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.accessdata.fda.gov
July 27, 2022K213252Dornier ThulioGEXSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
April 18, 2022K220871NautilusJAASubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
November 24, 2021K211169Bronchoscope SystemEOQSubstantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.accessdata.fda.gov
May 19, 2021K210394Electrosurgical accessoryFASSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
November 20, 2020K201815Dornier MAGELLAN Ureteral Access SheathFEDSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
December 6, 2019K190612EQUINOX Balloon Dilatation CatheterEZNSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
November 15, 2019K190312Dornier Ureteral StentFADSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
September 18, 2019K191187Dornier MINNOW Ureteral CatheterEYBSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
July 3, 2018K180367Ureterorenoscope SystemFGBSubstantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.accessdata.fda.gov
March 7, 2018K180350Dornier Medilas H Solvo 35 LaserGEXSubstantially EquivalentDornier Medtech Americaaccessdata.fda.gov
March 31, 2017K161257MultiPulse HoPLUSGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
July 28, 2016K161771Medilas H Laser FibersGEXSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
June 27, 2016K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeFASSubstantially EquivalentOmnitech Systems, Inc.accessdata.fda.gov
October 8, 2015K152591Medilas H RFID Laser FibersGEXSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
December 14, 2012K123385MEDILAS H LASER FIBERSGEXSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
August 1, 2012K121938MEDILAS H RFID LASER FIBERGEXSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov
August 21, 2002K022544DORNIER MEDILAS H LASER FIBER CABLESGEXSubstantially EquivalentDornier Medtech America, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 1, 201982625Class IITerminatedDornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 miPin hole package failures compromising sterility of productaccessdata.fda.gov

Compare with other makers

Updated January 29, 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.