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Sign in to claim this brandGyrus Acmi, Inc.
United States·US-MF-000034237
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 9600, Louisiana Ave. North, , Brooklyn Park, MN, United States
- Website
- olympus-osta.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Dave Joppru
- EUDAMED SRN
- US-MF-000034237
- FDA FEI Number
- 3003790304
- DUNS Number
- —
Catalogue (2823)
Page 1 of 57| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gyrus Acmi | 70141080 | FDA UDI | Class II | Active |
| Gyrus ACMI | 400-2100 | FDA UDI | Class II | Active |
| Soltive | TFL-APCUS | FDA UDI | Class II | Active |
| Gyrus Acmi, Inc | 140144-ENT | FDA UDI | Class II | Active |
| Gyrus Acmi, Inc | 140106 | FDA UDI | Class II | Active |
| Gyrus Acmi | 70245014 | FDA UDI | Class II | Active |
| Gyrus ACMI | 7089-0853 | FDA UDI | Class I | Unknown |
| Gyrus Acmi | 5720004 | FDA UDI | Class II | Active |
| Martin Incudo Prosthesis | 70921564 | FDA UDI | Class II | Unknown |
| Soltive | TFL-AVC | FDA UDI | Class II | Active |
| Gyrus ACMI | 911100 | FDA UDI | Class II | Unknown |
| Gyrus Acmi | 5700001 | FDA UDI | Class II | Active |
| Gyrus ACMI | 240060 | FDA UDI | Class II | Active |
| Diego | 70338008 | FDA UDI | Class II | Active |
| Tecoflex | 5604516 | FDA UDI | Class II | Active |
| Gyrus Acmi | 70327039 | FDA UDI | Class I | Active |
| Gyrus Acmi | 5720003 | FDA UDI | Class II | Active |
| USA Elite | E121-O | FDA UDI | Class II | Active |
| Gyrus Acmi | 145220-ENT | FDA UDI | Class II | Active |
| Gyrus Acmi | 70327011 | FDA UDI | Class I | Active |
| Gyrus ACMI | 70140986 | FDA UDI | Class II | Active |
| nCare | 1006538 | FDA UDI | Class I | Active |
| Evonos | 130154 | FDA UDI | Class I | Active |
| Gyrus ACMI | 70140730 | FDA UDI | Class II | Active |
| ShockPulse | SPL-G | FDA UDI | Class II | Active |
| Gyrus Acmi, Inc | 140771 | FDA UDI | Class II | Active |
| Double-J | 5204200 | FDA UDI | Class II | Active |
| Evonos | 131028 | FDA UDI | Class I | Active |
| Tecoflex | 5617024 | FDA UDI | Class II | Active |
| Gyrus ACMI | 245706 | FDA UDI | Class II | Active |
| Evonos | 130451 | FDA UDI | Class I | Active |
| Diego | 70138004 | FDA UDI | Class I | Active |
| Vocom | 143000 | FDA UDI | Class II | Active |
| Gyrus ACMI | 245704 | FDA UDI | Class II | Active |
| Diego Elite | BB2000SA | FDA UDI | Class II | Active |
| Gyrus ACMI | 140465 | FDA UDI | Class II | Active |
| Gyrus Acmi | 70326128 | FDA UDI | Class I | Active |
| Double-J | 5202800 | FDA UDI | Class II | Active |
| Evonos | 131080 | FDA UDI | Class I | Active |
| Gyrus Acmi | 5710001 | FDA UDI | Class II | Active |
| Gyrus ACMI | 70921605 | FDA UDI | Class II | Active |
| Diego | 70338007 | FDA UDI | Class II | Active |
| Gyrus Acmi | 70140396 | FDA UDI | Class II | Active |
| Gyrus Acmi | 70130933 | FDA UDI | Class I | Active |
| USA Elite | E152 | FDA UDI | Class II | Active |
| Gyrus Acmi | 70329035 | FDA UDI | Class I | Active |
| Gyrus ACMI | 70353107 | FDA UDI | Class II | Active |
| Diego | 70138033 | FDA UDI | Class I | Active |
| Evonos | 130549 | FDA UDI | Class I | Active |
| Tecoflex | 5557028 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Recalls (24)
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 |
|---|---|---|---|---|
| Mar 8, 2019 | Z-1183-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1180-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1182-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1184-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1178-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1181-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1187-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1179-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1186-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1185-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Aug 3, 2017 | Z-1337-2018 | — | open, classified | "Chattering" when cutting burrs are used in bone. |
| Jan 8, 2010 | Z-0797-2010 | — | terminated | Units of the product in lot MH136952 may have been shipped without being sterilized. |
| Aug 18, 2009 | Z-0635-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0632-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0636-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0633-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0637-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0634-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Oct 1, 2008 | Z-0273-2009 | — | terminated | Sterility may be compromised |
| Jun 25, 2008 | Z-2226-2008 | — | terminated | Particulate matter in the catheter |
| May 23, 2007 | Z-1073-2007 | — | terminated | Sterilization Instructions not adequate for sterilizing. |
| Feb 19, 2007 | Z-0613-2007 | — | terminated | Product sterility may be compromised due to failure of the tray seal packaging |
| Feb 19, 2007 | Z-0615-2007 | — | terminated | Product sterility may be compromised due to failure of the tray seal packaging |
| Feb 19, 2007 | Z-0614-2007 | — | terminated | Product sterility may be compromised due to failure of the tray seal packaging |