Medical Device Manufacturer · US , Kennesaw , GA

Dornier Medtech America Inc (Dmta)

1 submissions · 1 cleared · Since 2025
1
Total
1
Cleared
0
Denied

Dornier Medtech America Inc (Dmta) — FDA 510(k) Submissions

Dornier Medtech America Inc (Dmta) has submitted 1 FDA 510(k) premarket notifications since 2025, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Electrosurgical, Active, Urological . Use the specialty filter in the sidebar to narrow results.

1 devices
1–1 of 1
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 · FAS Electrode,... · Gastroenterology & Urology
Dec 2025 213d
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