FDA.reportPublic FDA data

DORNIER MEDTECH AMERICA, INC.

Matched from indexed company URL: Dornier MedTech America

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10379551037955DORNIER MEDTECH AMERICA, INC.1Y2026-01-011155 ROBERTS BLVD. KENNESAW GA US 30144

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
287491593624570K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)FGB2025-10-03
287491571913549K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)GEX2025-11-24
287491290984571K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)GEX2025-11-24
287491018829777K251403Dornier 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 )FAS2025-12-05
287491111037903K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)FGB2025-04-11
287491780540178K243820Hoover 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-1250FED2025-01-31
287491800635648K243497Portable 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-28USEOQ2025-05-29
287491595986729K233380TRIDENT Mobile Fluoroscopy SystemJAA2024-06-26
287491549196480K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)FGB2022-10-05
287492059220357K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ2022-11-09
287491377901656K221903Delta III ProLNS2023-02-22
287491879560615K220871NautilusJAA2022-04-18
287491016536111K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)FGB2022-08-26
287491342460216K213252Dornier ThulioGEX2022-07-27
287491812218477K211169Bronchoscope SystemEOQ2021-11-24
287491181301055K210394Electrosurgical accessoryFAS2021-05-19
287491838680306K201815Dornier MAGELLAN Ureteral Access SheathFED2020-11-20
287491786147525K191187Dornier MINNOW Ureteral CatheterEYB2019-09-18
287491036581533K190612EQUINOX Balloon Dilatation CatheterEZN2019-12-06
287491737013321K190312Dornier Ureteral StentFAD2019-11-15
287491917533831K180367Ureterorenoscope SystemFGB2018-07-03
287491414819182K180350Dornier Medilas H Solvo 35 LaserGEX2018-03-07
287492035803543K161771Medilas H Laser FibersGEX2016-07-28
287491426891722K161257MultiPulse HoPLUSGEX2017-03-31
287492019867468K152591Medilas H RFID Laser FibersGEX2015-10-08
287491464464011K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeFAS2016-06-27
287491627195623K123385MEDILAS H LASER FIBERSGEX2012-12-14
287491575681566K121938MEDILAS H RFID LASER FIBERGEX2012-08-01
287491276438754K022544DORNIER MEDILAS H LASER FIBER CABLESGEX2002-08-21
287491205678849
287491558965310
287491867456603
287492006856800

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX102025-11-24
FGB52025-10-03
FAS32025-12-05
EOQ22025-05-29
FED22025-01-31
JAA22024-06-26
LNS12023-02-22
FAJ12022-11-09
EZN12019-12-06
FAD12019-11-15
EYB12019-09-18

PMA#

UROWAVE

1999-03-12

Dornier MedTech America, Inc.

68 records. Showing 1-40. Next

PMN#

Nautilus

2022-04-18

Dornier Medtech America, Inc.

GENESIS

2015-06-30

DORNIER MEDTECH AMERICA, INC.

GENESIS

2013-01-18

DORNIER MEDTECH AMERICA, INC.

45 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next