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Dornier MedTech America, Inc.

US

Last updated September 17, 2026

What Dornier MedTech America, Inc. makes

Dornier MedTech America, Inc. manufactures laser lithotripsy systems and general surgical laser beam guides. Their portfolio also includes single-use gastro-urological guidewires, polymeric ureteral stents, urinary stone retrieval baskets, urethral dilators, endoscopic bipolar electrosurgical electrodes, and ureteral introduction sheaths.

The company is based in the United States, and its products are regulated as Class I, Class II, and Class III medical devices. These devices are listed in the FDA 510(k), FDA PMA, and FDA UDI databases.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
1155 ROBERTS BLVD., KENNESAW, GA, 30144
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1037955
DUNS Number
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Catalogue (244)

Page 5 of 5
DeviceModel / ReferenceRegistriesClassStatus
Dornier Medilas H Laser Fiber Cables K022544
FDA 510(k)
Class IIActive
Medilas H Rfid Laser Fiber K121938
FDA 510(k)
Class IIActive
Hoover 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-1250 K243820
FDA 510(k)
Class IIActive
Nautilus K220871
FDA 510(k)
Class IIActive
Tca 5r / 5s K070123
FDA 510(k)
Class IIActive
Medilas H RFID Laser Fibers K152591
FDA 510(k)
Class IIActive
Delta III Lithotripter K201074
FDA 510(k)
Class IIActive
Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems K021724
FDA 510(k)
Class IIActive
Dornier MINNOW Ureteral Catheter K191187
FDA 510(k)
Class IIActive
Dornier Medila H K983963
FDA 510(k)
Class IIActive
Extra Corporeal Shockwave Lithotripter K132672
FDA 510(k)
Class IIActive
Electrosurgical accessory K210394
FDA 510(k)
Class IIActive
Flexisys K904149
FDA 510(k)
Class IIActive
Dornier Medilas D Litebeam+ 1470 K110364
FDA 510(k)
Class IIActive
Dornier 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 ) K251403
FDA 510(k)
Class IIActive
TRIDENT Mobile Fluoroscopy System K233380
FDA 510(k)
Class IIActive
Dornier Compact Alpha Lithotripter K002929
FDA 510(k)
Class IIActive
EQUINOX Balloon Dilatation Catheter K190612
FDA 510(k)
Class IIActive
Delta III Lithotripter K170122
FDA 510(k)
Class IIActive
Urotract I K955019
FDA 510(k)
Class IActive
Dornier Medilas Fiber Tome Laser K964760
FDA 510(k)
Class IIActive
Dornier Ureteral Stent K190312
FDA 510(k)
Class IIActive
Dornier Fibertome 100 Watt Surgical Laser K921549
FDA 510(k)
Class IIActive
Dornier Sapphireerbium Handpiece, Dornier Sapphirespot Handpiece K011322
FDA 510(k)
Class IIActive
Delta III Lithotripter K172084
FDA 510(k)
Class IIActive
Medilas D Family Lasers, Including Medilas D Litebeam, Litebeam +, Urobeam, Multibeam, Flexipulse And Magnapulse K083258
FDA 510(k)
Class IIActive
Medilas D Family Lasers K073427
FDA 510(k)
Class IIActive
Medilas H Laser Fibers K161771
FDA 510(k)
Class IIActive
Dornier Laser Lithotripter Impact K913191
FDA 510(k)
Class IIActive
Dornier MAGELLAN Ureteral Access Sheath K201815
FDA 510(k)
Class IIActive
Dornier Medilas Uropulse K130344
FDA 510(k)
Class IIActive
Medilas 4060n Fibertom(r) Surgical Laser K904155
FDA 510(k)
Class IIActive
Genesis Ii K133434
FDA 510(k)
Class IIActive
Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System K020339
FDA 510(k)
Class IIActive
Dornier Medilas H Solvo 35 Laser K180350
FDA 510(k)
Class IIActive
Medilas D Family Lasers, Including Medilas D Litebeam, Litebeam +, Urobeam, Multibeam, Flexipulse And Magnapulse K083500
FDA 510(k)
Class IIActive
Gemini Lithotripter K121656
FDA 510(k)
Class IIActive
Gemini XXP-HP K151298
FDA 510(k)
Class IIActive
Genesis K151485
FDA 510(k)
Class IIActive
Medilas D Family Lasers K070536
FDA 510(k)
Class IIActive
Dornier Medilas H 20 Laser K061455
FDA 510(k)
Class IIActive
Dornier Epos Ultra P000048
FDA PMA
Class IIIActive
Dornier Urowave Microwave Thermotherapy System P970044
FDA PMA
Class IIIActive
Dornier Lithotripter, Model Hm3 P840008
FDA PMA
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There is one recall record for Dornier MedTech America, Inc. initiated on 2019-04-01. The status of this record is terminated, and the reason provided is pin hole package failures compromising the sterility of the product.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Apr 1, 2019Z-1381-2019—terminated

Pin hole package failures compromising sterility of product