Data / Medical devices / Ireland / Merck Millipore Ltd.
Merck Millipore Ltd.: FDA-registered device maker in COUNTY CORK Munster, Ireland, 7 510(k) clearances
Merck Millipore Ltd. is registered with the FDA (registration 8020892) in COUNTY CORK Munster, Ireland. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 11, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020892
- FEI number
- 1000532580
- Address
- Tullagreen Carrigtwohill, COUNTY CORK Munster, Ireland, --
- Owner or operator
- MilliporeSigma (1216103)
- Roles
- Manufacturer
- First device listed
- January 4, 1993
- Registered through
- 2026
- Brand names listed
- Amicon Ultra - 15, Amicon Ultra - 4, Cathivex-GV Filter Units, Centrifree, Dualex Plus TP, Dualex TP, Dualex Ultra TP, Millex - MP Filter Units and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | 1 | Manufacturer | accessdata.fda.gov |
| Filter, Conduction, Anesthetic | BSN | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Infusion Line | FPB | 2 | Manufacturer | accessdata.fda.gov |
| Protector, Transducer, Dialysis | FIB | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Filter, Membrane | JRL | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2015 | K143583 | Cathivex ¿GV filter units | FPB | Substantially Equivalent | Merck Millipore , Ltd. | accessdata.fda.gov |
| March 27, 2014 | K133004 | VENTED MILLEX -GV, CATHIVEX -GV | BSN | Substantially Equivalent | Merck Millipore , Ltd. | accessdata.fda.gov |
| January 17, 2003 | K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | BSN | Substantially Equivalent | Millipore Corp. | accessdata.fda.gov |
| April 4, 2002 | K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | BSN | Substantially Equivalent | Millipore Corp. | accessdata.fda.gov |
| June 10, 1997 | K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | BSN | Substantially Equivalent | Millipore Corp. | accessdata.fda.gov |
| April 21, 1994 | K934069 | MILLEX, DUALEX (PLUS, ULTRA) | FIB | Substantially Equivalent | Millipore Corp. | accessdata.fda.gov |
| June 14, 1977 | K770703 | FILTER UNIT, SINGLE USE | FPB | Substantially Equivalent | Millipore Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 14, 2018 | 81122 | Class II | Terminated | Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon cli | In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have increased concentration times of greater than the specification of 3 hours and up to 24 hours, which may lead to delays in carrying out the subsequent analysis tests. | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Conduction, Anesthetic
- All makers of Protector, Transducer, Dialysis
- All makers of Filter, Infusion Line
- All makers of Unit, Filter, Membrane
- All makers of Clinical Sample Concentrator
Updated August 11, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.