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Sign in to claim this brandDornier 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
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1037955
- DUNS Number
- —
Catalogue (244)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dornier MedTech | 600 Micron Reusable | FDA UDI | Class II | Active |
| Dornier MedTech | 400 micron single use SMA | FDA UDI | Class II | Active |
| Dornier MedTech | 270 micron Holmium Laser Fiber Cable, Single Use, RFID (slim, ball tip) | FDA UDI | Class II | Active |
| Dornier MedTech | Dornier Medilas H 270 Micron Single Use Ball Tip Laser Fiber - LATAM | FDA UDI | Class II | Active |
| Dornier MedTech | Equinox Ureteral Dilatation Balloon, 5mm x 4cm | FDA UDI | Class II | Active |
| Dornier MedTech | 270 Micron Reusable | FDA UDI | Class II | Active |
| Dornier MedTech | Equinox Ureteral Dilatation Balloon, 6mm x 10cm Kit | FDA UDI | Class II | Active |
| Dornier MedTech | Angle, Flexible Tip, Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | 600 Micron Reusable HE | FDA UDI | Class II | Active |
| Dornier MedTech | Dornier Magellan Ureteral Access Sheath, 12/14Fr x 45cm | FDA UDI | Class II | Active |
| Dornier MedTech | 270 Micron Single Use HE | FDA UDI | Class II | Active |
| Dornier MedTech | Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use. (6/box) | FDA UDI | Class II | Active |
| Dornier MedTech | BEZ15120 | FDA UDI | Class II | Active |
| Dornier MedTech | Angle, Flexible Tip, Regular | FDA UDI | Class I | Active |
| Dornier MedTech | Dual Flex with Hydrophilic Tip, Straight, Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use. (6/box) | FDA UDI | Class II | Active |
| Dornier MedTech | Cascade Ureteral Stent, 7Fr x 26cm | FDA UDI | Class II | Active |
| Dornier MedTech | 400 Micron SU Thulio Performance 3m Fiber | FDA UDI | Class II | Active |
| Dornier MedTech | 270 micron Holmium Laser Fiber Cable, Reusable, RFID | FDA UDI | Class II | Active |
| Dornier MedTech | 2.5Fr x 120cm, Short Tip 4 Wire Basket | FDA UDI | Class II | Active |
| Dornier MedTech | 1.5Fr x 120cm, Tipless Basket | FDA UDI | Class II | Active |
| Dornier MedTech | Dornier Magellan Ureteral Access Sheath, 10/12Fr x 35cm | FDA UDI | Class II | Active |
| Dornier MedTech | Dual Flex with Hydrophilic Tip, Angle, Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | Cascade Ureteral Stent, 4.9Fr x 14cm | FDA UDI | Class II | Active |
| Dornier MedTech | 200 Series Flex Single Use | FDA UDI | Class II | Active |
| Dornier MedTech | 400 micron Holmium Laser Fiber Cable, Reusable, RFID | FDA UDI | Class II | Active |
| Dornier MedTech | 400 Micron SU Thulio Performance 4.5m Fiber | FDA UDI | Class II | Active |
| Dornier MedTech | Dornier Medilas H 400 Micron Single Use Laser Fiber - LATAM | FDA UDI | Class II | Active |
| Dornier MedTech | 400 Micron Reusable | FDA UDI | Class II | Active |
| Dornier MedTech | Cascade Ureteral Stent, 7Fr x 20cm | FDA UDI | Class II | Active |
| Dornier MedTech | 1000 Micron Single Use | FDA UDI | Class II | Active |
| Dornier MedTech | 200 Micron Ball Tip Single Use HE | FDA UDI | Class II | Active |
| Dornier MedTech | 2.2Fr x 120cm, Tipless Basket | FDA UDI | Class II | Active |
| Dornier MedTech | Dornier 600 µm Single-Use SMA Diode Laser Fiber with Fixed Rinsing Tube 2.1mm No | FDA UDI | Class II | Active |
| Dornier MedTech | 200 Micron SU Thulio Performance Ball-Tip 3m Fiber | FDA UDI | Class II | Active |
| Dornier MedTech | PTFE Coated Guide Wire, Straight, Flexible Tip, Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | Dornier 600 µm Single-Use SMA Diode Laser Fiber with Adjustable Rinsing Tube 3.5 | FDA UDI | Class II | Active |
| Dornier MedTech | Dual Flex with Hydrophilic Tip, Angle, Super Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | Equinox Ureteral Dilatation Balloon, 5mm x 4cm Kit | FDA UDI | Class II | Active |
| Dornier MedTech | Dornier 600 µm Single-Use SMA Diode Laser Fiber 2.5m | FDA UDI | Class II | Active |
| Dornier MedTech | Cascade Ureteral Stent, 7Fr x 22cm | FDA UDI | Class II | Active |
| Dornier MedTech | 400 Micron Reusable HE | FDA UDI | Class II | Active |
| Dornier MedTech | 270 Micron SU Thulio Performance 3m Fiber | FDA UDI | Class II | Active |
| Dornier MedTech | Bipolar Needle 24 Fr. Electrode-Sterile, Single-Use. (6/box) | FDA UDI | Class II | Active |
| Dornier MedTech | Dual Flex with Hydrophilic Tip, Straight, Super Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | 600 micron single use luer lock | FDA UDI | Class II | Active |
| Medilas H Laser Fibers | K123385 | FDA 510(k) | Class II | Active |
| Dornier Medilas D 30 Laser, Medilas D 1064 | K080959 | FDA 510(k) | Class II | Active |
| Genesis | K122768 | FDA 510(k) | Class II | Active |
| Dornier Medilas H30 Solvo | K122159 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 1, 2019 | Z-1381-2019 | — | terminated | Pin hole package failures compromising sterility of product |