Data / Medical devices / Ireland / Covidien
Covidien: FDA-registered device maker in - Galway(County), Ireland, 18 510(k) clearances and 1 PMA approval
Covidien is registered with the FDA (registration 8020893) in - Galway(County), Ireland. It lists 14 device types. The FDA files 18 510(k) clearances and 1 PMA approval under its listings, the newest dated July 21, 2023. 2 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8020893
- FEI number
- 3002807850
- Address
- Michael Collins Road, H91 W9N4 Mervue, - Galway(County), Ireland, -
- Owner or operator
- Covidien llc (1282497)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 24, 2005
- Registered through
- 2027
- Brand names listed
- 840 Vent with VV+, DC compressor, EndoFlip Catheter, EndoFlip System, Endoflip 300 System, Flip Topography Module, HT70, INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiac Ablation Percutaneous Catheter | LPB | 3 | Manufacturer | accessdata.fda.gov |
| Cerebral Oximeter | QEM | 2 | Manufacturer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Manufacturer | accessdata.fda.gov |
| Continuous, Ventilator, Home Use | NOU | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Specification developer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Ear | DPZ | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Tissue Saturation | MUD | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Manufacturer | accessdata.fda.gov |
| System, Gastrointestinal Motility (Electrical) | FFX | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | 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 |
|---|---|---|---|---|---|---|
| July 21, 2023 | K231861 | EndoflipTM 300 System | FFX | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 5, 2021 | K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) | MUD | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 20, 2020 | K193056 | Puritan Bennett 980 Series Ventilator System | CBK | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| February 15, 2019 | K183072 | EndoFLIP System | FFX | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| March 29, 2016 | K151252 | Puritan Bennett 840 Series Ventilator System | CBK | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| March 5, 2015 | K141518 | Nellcor Bedside Respiratory Patient Monitoring System | DQA | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 4, 2014 | K130320 | BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW | DQA | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 9, 2013 | K123581 | NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN | DQA | Substantially Equivalent | Covidien, Formerly Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| December 1, 2011 | K111146 | NEWPORT HT70 VENTILATOR | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| September 8, 2010 | K101803 | NEWPORT E360 VENTILATOR | CBK | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
| July 9, 2009 | K091224 | OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S | MUD | Substantially Equivalent | Somanetics Corp. | accessdata.fda.gov |
| April 3, 2009 | K082327 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C | MUD | Substantially Equivalent | Somanetics Corp. | accessdata.fda.gov |
| August 11, 2005 | K051352 | OXIMAX NPB-40 HANDHELD PULSE OXIMETER | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| September 27, 2002 | K022103 | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM | BZG | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| August 13, 2002 | K021573 | PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION | CBK | Substantially Equivalent - Subject to Tracking Reg. | Puritan-Bennett | accessdata.fda.gov |
| March 7, 2002 | K012891 | OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| July 7, 1995 | K952428 | POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
| May 21, 1986 | K860373 | THE M100 AIR/OXYGEN MIXER | BZR | Substantially Equivalent | Newport Medical Instruments, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 17, 2003 | P020045 | 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM | LPB | 102 | April 23, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 19, 2022 | 90766 | Class II | Ongoing | Puritan Bennett 560 Ventilator, PB560, CFN 4096600 | Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components. | accessdata.fda.gov |
| March 25, 2022 | 89820 | Class I | Ongoing | Puritan Bennett 980 Series Ventilator | The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Ventilator, Continuous, Facility Use
- All makers of Compressor, Air, Portable
- All makers of Cardiac Ablation Percutaneous Catheter
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
Updated April 23, 2026. 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.