Dideco S.P.A. FDA Record
Dideco S.P.A. has 0 FDA recalls, 0 inspections, 33 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Dideco S.P.A." is on file.
- Latest 510(k)
- Oct 20, 2005
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 33 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K052717 | D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER | Oct 20, 2005 |
| K051232 | D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL… | May 20, 2005 |
| K050890 | ECC.O SYSTEM | May 5, 2005 |
| K050447 | PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | Mar 8, 2005 |
| K043323 | D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | Feb 1, 2005 |
| K041061 | D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS | May 6, 2004 |
| K033323 | D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER… | Jan 13, 2004 |
| K033987 | D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS | Jan 8, 2004 |
| K033714 | MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING | Dec 11, 2003 |
| K032040 | IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT… | Jul 9, 2003 |
| K031223 | SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR | May 2, 2003 |
| K030154 | IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT… | Mar 31, 2003 |
| K021732 | DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO… | Nov 4, 2002 |
| K022450 | INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL… | Oct 22, 2002 |
| K020647 | DIDECO ELECTA | Sep 5, 2002 |
| K020997 | APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | Apr 4, 2002 |
| K020351 | D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR | Feb 26, 2002 |
| K014080 | APEX ADULT HOLLOWE FIBER OXYGENATOR | Jan 8, 2002 |
| K013915 | D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER | Dec 27, 2001 |
| K004001 | MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR | Oct 4, 2001 |
Dideco S.P.A. and the FDA: common questions
Has Dideco S.P.A. received an FDA warning letter?
No FDA warning letter addressed to the name "Dideco S.P.A." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Dideco S.P.A. received an FDA Form 483?
FDA has not published a Form 483 for "Dideco S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.
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