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Sign in to claim this brandDornier MedTech America, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1155 ROBERTS BLVD., KENNESAW, GA, 30144
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1037955
- DUNS Number
- —
Catalogue (244)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dornier MedTech | 400 Micron Reusable | FDA UDI | Class II | Active |
| Dornier MedTech | Angle, Flexible Tip, Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | Cascade Ureteral Stent, 6Fr x 22cm | FDA UDI | Class II | Active |
| Dornier MedTech | 600 micron Holmium Laser Fiber Cable, Reusable, French Cycle, RFID | FDA UDI | Class II | Active |
| Dornier MedTech | Straight, Flexible Tip, Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | Cascade Ureteral Stent, 8Fr x 22-32cm Variable | FDA UDI | Class II | Active |
| Dornier MedTech | Slim 270 Micron Reusable | FDA UDI | Class II | Active |
| Dornier MedTech | Slim 270 Micron Ball Tip Single Use | FDA UDI | Class II | Active |
| Dornier MedTech | Cascade Ureteral Stent, 4.9Fr x 28cm | FDA UDI | Class II | Active |
| Dornier MedTech | PTFE Coated Guide Wire, Angle, Flexible Tip, Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | Dornier 400 µm Single-Use SMA Diode Laser Fiber 2.5m | FDA UDI | Class II | Active |
| Dornier MedTech | Straight, Flexible Tip, Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | Equinox Ureteral Dilatation Balloon, 6mm x 4cm | FDA UDI | Class II | Active |
| Dornier MedTech | Dornier 600 µm Single-Use SMA UroBeam Diode Laser Fiber 3.5m | FDA UDI | Class II | Active |
| Dornier MedTech | 3 Wire Stone Grasper 2.0Fr, 120cm, 3 wire | FDA UDI | Class II | Active |
| Dornier MedTech | 1000 Micron Reusable | FDA UDI | Class II | Active |
| Dornier MedTech | DMTL SmartFlex 600 High Energy Reusable (5X) | FDA UDI | Class II | Active |
| Dornier MedTech | Equinox Ureteral Dilatation Balloon, 6mm x 10cm | FDA UDI | Class II | Active |
| Dornier MedTech | 400 micron single use luer lock | FDA UDI | Class II | Active |
| Dornier MedTech | 1000 Micron Reusable HE | FDA UDI | Class II | Active |
| Dornier MedTech | 600 Micron SU Thulio Performance 3m Fiber | FDA UDI | Class II | Active |
| Dornier MedTech | 2.5Fr x 120cm, Short Tip 4 Wire Basket | FDA UDI | Class II | Active |
| Dornier MedTech | APP3515S | FDA UDI | Class I | Active |
| Dornier MedTech | DMTL SmartFlex 400 High Energy Reusable (5X) | FDA UDI | Class II | Active |
| Dornier MedTech | Equinox Ureteral Dilatation Balloon, 4mm x 4cm | FDA UDI | Class II | Active |
| Dornier MedTech | 365 micron single use luer lock | FDA UDI | Class II | Active |
| Dornier MedTech | Holmium 270um 3M Fiber 3ST 10X Use- LATAM Non-RFID Reusable | FDA UDI | Class II | Active |
| Dornier MedTech | Cascade Ureteral Stent, 8Fr x 22cm | FDA UDI | Class II | Active |
| Dornier MedTech | Bipolar Cable, ESG-400 Generator | FDA UDI | Class II | Active |
| Dornier MedTech | 1.5Fr x 120cm, 8mm Open Tip | FDA UDI | Class II | Active |
| Dornier MedTech | 600 micron Holmium Laser Fiber Cable, Reusable, RFID | FDA UDI | Class II | Active |
| Dornier MedTech | Dual Flex with Hydrophilic Tip, Straight, Super Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | PTFE Coated Guide Wire, Angle, Flexible Tip, Stiff | FDA UDI | Class I | Active |
| Dornier MedTech | Cascade Ureteral Stent, 8Fr x 20cm | FDA UDI | Class II | Active |
| Dornier MedTech | SLID3515S | FDA UDI | Class I | Unknown |
| Dornier MedTech | 1000 Micron Reusable | FDA UDI | Class II | Active |
| Dornier MedTech | Dornier Medilas H 270 Micron Single Use Laser Fiber - LATAM | FDA UDI | Class II | Active |
| Dornier MedTech | Cascade Ureteral Stent, 6Fr x 26cm | FDA UDI | Class II | Active |
| Dornier MedTech | 600 micron slim single use luer lock | FDA UDI | Class II | Active |
| Dornier MedTech | Minnow Ureteral Catheter, 5Fr x 70cm Open Tip - Left | FDA UDI | Class II | Active |
| Dornier MedTech | DMTL SmartFlex 270 High Energy Reusable (5X) | FDA UDI | Class II | Active |
| Dornier MedTech | Cascade Ureteral Stent, 4.9Fr x 22-32cm Variable | FDA UDI | Class II | Active |
| Dornier MedTech | Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use. (6/box) | FDA UDI | Class II | Active |
| Dornier MedTech | 600 Micron Reusable | FDA UDI | Class II | Active |
| Dornier MedTech | Cascade Ureteral Stent, 4.9Fr x 20cm | FDA UDI | Class II | Active |
| Dornier MedTech | Equipment Cover (Movement Footswitch) | FDA UDI | Class II | Active |
| Dornier MedTech | THULIO LL-R TM 1000µM 3M PERF. FIBER 3ST 10X USE | FDA UDI | Class II | Active |
| Dornier MedTech | 1000 micron Holmium Laser Fiber Cable, Single Use, RFID | FDA UDI | Class II | Active |
| Dornier MedTech | Dornier 550 µm Single-Use SMA UroBeam Diode Laser Fiber 3.5m | FDA UDI | Class II | Active |
| Dornier MedTech | Equinox Ureteral Dilatation Balloon, 4mm x 10cm | FDA UDI | Class II | Active |
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 1, 2019 | Z-1381-2019 | — | terminated | Pin hole package failures compromising sterility of product |