Lithotriptor, Ultrasonic
Gyrus Acmi, Inc.'s record for this product code
MDR events1,035All time
Recalls0All time
510(k) clearances0All time
Recent MDR events
1,035 adverse event reports on file
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 27, 2026Malfunction3011050570-2026-00758
- SHOCKPULSE LITHOTRIPSY FOOTSWITCHJul 27, 2026Malfunction3011050570-2026-00759
- SHOCKPULSE LITHOTRIPSY TRANSDUCER.Jul 27, 2026Malfunction3011050570-2026-00764
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 27, 2026Malfunction3011050570-2026-00765
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 21, 2026Malfunction3011050570-2026-00753
- SHOCKPULSE LITHOTRIPSY TRANSDUCER.Jul 21, 2026Malfunction3011050570-2026-00756
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 20, 2026Malfunction3011050570-2026-00745
- SHOCKPULSE LITHOTRIPSY TRANSDUCER.Jul 20, 2026Malfunction3011050570-2026-00749
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 20, 2026Malfunction3011050570-2026-00750
- SHOCKPULSE LITHOTRIPSY FOOTSWITCHJul 20, 2026Malfunction3011050570-2026-00752
Recalls
0 recall events for this product code
No recalls on file for Gyrus Acmi, Inc. under this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Gyrus Acmi, Inc. under this product code.