Gyrus Acmi, Inc.
2925 Appling Rd, BARTLETT, TN, US
Registered product codes
33 product codes
Recent MDR events
7,396 on file
- POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTIONJul 31, 2026Malfunction3011050570-2026-00772
- POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTIONJul 31, 2026Malfunction3011050570-2026-00773
- POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTIONJul 30, 2026Malfunction3011050570-2026-00769
- EZDILATE BALLOON DILATOR (FW) 18-19-20Jul 30, 2026Injury3011050570-2026-00770
- POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTIONJul 30, 2026Malfunction3011050570-2026-00771
- Single Use Aspiration Needle NA-U401SXJul 29, 2026Malfunction3011050570-2026-00767
- SOLTIVE Premium SuperPulsed Laser SystemJul 29, 2026Malfunction3011050570-2026-00768
- SHOCKPULSE-SE LITHOTRIPSY SYSTEMJul 27, 2026Malfunction3011050570-2026-00758
- SHOCKPULSE LITHOTRIPSY FOOTSWITCHJul 27, 2026Malfunction3011050570-2026-00759
- EZDILATE BALLOON DILATOR (FW) 18-19-20Jul 27, 2026Malfunction3011050570-2026-00760
Recalls
11 on file
- Open, ClassifiedMar 20, 2018
"Chattering" when cutting burrs are used in bone.
View FDA record ↗ - TerminatedUnknown
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
View FDA record ↗ - TerminatedUnknown
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
View FDA record ↗ - TerminatedUnknown
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
View FDA record ↗ - TerminatedUnknown
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
View FDA record ↗ - TerminatedUnknown
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
View FDA record ↗ - TerminatedUnknown
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
View FDA record ↗ - TerminatedUnknown
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
View FDA record ↗ - TerminatedUnknown
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
View FDA record ↗ - TerminatedUnknown
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
View FDA record ↗
Compliance history
Matched by FEI 1037007.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.