Erbe Elektromedizin GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253915MOVIVA® Hybrid Ablation ProbeDecember 18, 2025
K251108Erbe ESU Model VIO® 3n with AccessoriesAugust 29, 2025
K243120HybridAPC probeJune 20, 2025
K243451FiAPC plus probesMarch 21, 2025
K242044FiAPC plus probesAugust 26, 2024
K240932HybridTherm SystemAugust 5, 2024
K232033HYBRIDknife® flexNovember 29, 2023
K231023ERBEJET® 2 SystemJune 15, 2023
K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitcJanuary 7, 2020
K191234APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicDecember 20, 2019
K190823Erbe ESU Model VIO 3 with AccessoriesMay 22, 2019
K183445Erbe APCapplicatorsApril 4, 2019
K150364ERBE ESU Model VIO dV with AccessoriesMay 5, 2016
K934261ERBOKRYO CA CRYOSURGICAL SYSTEMApril 26, 1994