Company ยท AU
Compumedics Limited
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2025. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2025 | K252383 | Somfit D Compumedics Limited, AU | MNR |
| Feb 20, 2025 | K242447 | Falcon HST Compumedics Limited, AU | OLV |
| Nov 30, 2023 | K231546 | Somfit Compumedics Limited, AU | MNR |
| Feb 9, 2023 | K230073 | Okti Compumedics Limited, AU | GWQ |
| Feb 14, 2020 | K191785 | Orion LifeSpan MEG Compumedics Limited, AU | OLY |
| Jan 15, 2010 | K093223 | COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG Compumedics Limited, AU | GWQ |
| Sep 8, 2008 | K081151 | COMPUMEDICS NEUVO Compumedics USA, Ltd. | GWQ |
| Apr 14, 2008 | K072201 | COMPUMEDICS SOMTE PSG RECORDING SYSTEM Compumedics Limited, AU | MNR |
| Apr 23, 2004 | K040194 | COMPUMEDICS SUMMIT IP Compumedics USA, Ltd. | MNR |
| Dec 17, 2003 | K033052 | CONDUCTIVE EEG ELECTROLYTE Compumedics USA, Ltd. | GYB |
| Jan 21, 2003 | K021176 | COMPUMEDICS SOMTE SYSTEM Compumedics Limited | MNR |
| Dec 27, 2000 | K003175 | COMPUMEDICS SIESTA SYSTEM Compumedics Limited | OLV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2005 | Compumedics Usa, Ltd Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier. Terminated |
GWQ | None listed |
| Mar 24, 2005 | Compumedics Usa, Ltd Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia Terminated |
GWQ | K000068 |