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Resmed Corp

Active in EUDAMED
Also registered as Resmed Sas, Resmed, Ltd.

United Statesfrom SRN EUDAMED FDA SRN US-MF-000011805 FEI 1000115734

Resmed Corp is a medical device manufacturer based in the United States, with 136 devices listed in FDA 510(k), FDA GUDID and EUDAMED (FDA Class II and Unclassified; EU Class IIa) and 14 FDA recalls as of 14 Nov 2026.

Devices
136
Registrations
EUDAMEDFDA
FDA recalls
149 ongoing

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA 510(k) 118
  • FDA GUDID 11
  • EUDAMED 7

A device listed in two registries counts in both.

Device classes
  • FDA Class II 128
  • EU Class IIa 7
  • FDA Unclassified 1
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN US-MF-000011805
  • FDA FEI 1000115734
  • DUNS 080243150

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls

What Resmed Corp makes

Resmed Corp manufactures reusable nasal and face masks for CPAP/BPAP therapy, home CPAP and BPAP units, ventilator application software, heated respiratory humidifiers, portable electric ventilators, and reusable ventilator breathing circuits. Examples include the AIRFIT F40 and F20 masks, the MIRAGE QUATTRO humidifier, and the portable ventilator OXYGEN PORT.

The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded under 510(k) clearances and the Unique Device Identifier (UDI) database. These products are listed in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue136

Newest first, rows 1-50 of 136

Search and filter all 136 devices
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  • AirView EU BOM Ref 22241

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Myair Emea Ios App Ref 22257

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Easycare Tx 2 Web Delivery Ref 22225

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Orion 22291

    Listed Registry: GUDID Class:II

  • Orion Ref K253553

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EasyCare Tx 2 Ref K261360

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • AirView EU BOM Ref 22241

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Myair Emea Android App Ref 22258

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Easycare Tx 2 Install Cd Ref 22426

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Resscan Essentials -Web Ref 23201

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ResScan Essentials Ref K254104

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • AirView 22240

    Listed Registry: GUDID Class:II

  • ResScan 31339

    Listed Registry: GUDID Class:II

  • AirView 22240

    Listed Registry: GUDID Class:II

  • ResScan 31337

    Listed Registry: GUDID Class:II

  • Narval Cc 200002

    Active Regimes: 510(k) Registry: GUDID Class:II

  • ResScan 31338

    Listed Registry: GUDID Class:II

  • myAir 22246

    Listed Registry: GUDID Class:II

  • RMDpulse 22254

    Listed Registry: GUDID Class:II

  • RMDpulse 22253

    Listed Registry: GUDID Class:II

  • myAir 22245

    Listed Registry: GUDID Class:II

  • Swift Fx Ref K090244

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rescan Ref K034033

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Autoset Spirit System Ref K032480

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Geo Ref K121705

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vpap Iii St-A Ref K093731

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vpap Tx Ref K092186

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Humidaire 2I Ref K080797

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mirage Activa Mask Ref K032916

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Easycare Tx, Tx Link Ref K092026

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • VPAP Adapt SV, VPAP Tx, S9 VPAP Tx Ref K161487

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sullivan Vpap Ii St Nasal Vpap System Ref K961783

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • S7 Elite Cp Ap System Ref K013909

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Resmed S8 Pioneer Cpap System Ref K041209

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • S8 Advance Ref K082979

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Swift Fx Bella Ref K112489

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rescontrol Ii Ref K040944

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mirage Full Face Mask Series 2 Ref K023284

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Res Traxx Data Center Ref K051314

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Easycare Tx System (Connexuns) Ref K113780

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Txcontrol Ref K072615

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sullivan Autoset Home Nasal Cpap System Ref K970516

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Resscan Ref K050775

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Moore Park Mask Ref K183512 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mirage Vista Mask Ref K031047

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vpap Adapt Ref K051364

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mirage Micro Model 16333 (S), 16334 (M&L), 16335 (Lw & Xl) Ref K100772

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mirage Quattro Full Face Mask Ref K063122

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • S9 Cronulla For Her Ref K132606

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • S8 Escape Ii Ref K080079

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 136

Showing 1-50 of 136

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000011805
FDA FEI number
1000115734
DUNS number
080243150
EUDAMED status
Active
EUDAMED registered name
ResMed Corp.
Registered address
9001, Spectrum Center Blvd, 92123, San Diego, United States
Phone
800-424-0737
PRRC contact
David Lanfranchi(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 12 Sep 2027

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 083904 0009 Expiring Supplemented Expires in 302 days

    Quality management system EU MDR

    Issued
    29 May 2024
    Expires
    12 Sep 2027
    Reason
    Add device or group

FDA recalls14

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 14 recalls initiated by Resmed Corp, the earliest on 2007-04-23 and the most recent on 2026-06-25. By recorded status: 9 ongoing, 4 terminated and 1 with another status. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 1
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 8
  • 2024 0
  • 2025 0
  • 2026 1

4 initiated before 2017

Showing the 10 most recent of 14 recalls.

  • 2026

    • 25 Jun 2026 Z-2735-2026 Class I Ongoing Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Israel, Italy, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Martin (French part), Saudi Ar…
      Submission numbers: K152068, K172875

  • 2023

    • 20 Nov 2023 Z-0536-2024 Class I Ongoing Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact Distribution: US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU,…
      Full distribution text US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA
      Submission number: K132887
    • 20 Nov 2023 Z-0537-2024 Class I Ongoing Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact Distribution: US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU,…
      Full distribution text US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA
      Submission number: K170924
    • 20 Nov 2023 Z-0538-2024 Class I Ongoing Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact Distribution: US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU,…
      Full distribution text US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA
      Submission number: K153563
    • 20 Nov 2023 Z-0539-2024 Class I Ongoing Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact Distribution: US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU,…
      Full distribution text US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA
      Submission number: K171212
    • 20 Nov 2023 Z-0540-2024 Class I Ongoing Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact Distribution: US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU,…
      Full distribution text US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA
      Submission number: K161978
    • 20 Nov 2023 Z-0541-2024 Class I Ongoing Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact Distribution: US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU,…
      Full distribution text US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA
      Submission number: K170924
    • 20 Nov 2023 Z-0542-2024 Class I Ongoing Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact Distribution: US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU,…
      Full distribution text US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA
      Submission number: K183512
    • 13 Sep 2023 Z-0111-2024 Class I Ongoing If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sound for less than 2 minutes or not at all Distribution: Worldwide - US Nationwide distribution including in the states of CA, NJ, VA, IN, MI, WV, NY, WI, ND, IL, NC, FL, CO,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of CA, NJ, VA, IN, MI, WV, NY, WI, ND, IL, NC, FL, CO, TX, AL, LA, MD, OR, AZ, MN, WA, PA, SC, MA, ID, GA, SD, TN, NH, OH, MS, CT, IA, KY, UT, NE, MO, NV, AR, WY, RI, KS, VT, ME, OK, PR, MO, DC and the countries of Taiwan, Israel, Spain, Slovenia, Belgium, Italy, Australia, Guatemala, Argentina, Uruguay, Chile, France, Martinique, Germany, French Polynesia, Korea, Egypt, Colombia, United Kingdom, Jersey, Ecuador, Reunion, Greece, Brazil, Cyprus, Saudi Arabia, Czech Republic, Thailand, New Caledonia, Mauritius, Canada, Vietnam, Indonesia, Pakistan, Japan, Guadeloupe, South Africa, Iran, Hungary, Tunisia, Nepal, Iceland, New Zealand, Austria, Portugal, Malaysia, Norway, Netherlands, Sweden, Lebanon, Finland, Singapore, United Arab Emirates, Peru, Oman, Philippines, Bahrain, French Guiana, Mexico, Sri Lanka, India, Kuwait, Bangladesh, Kenya, Myanmar, Turkey, Bulgaria, Croatia, Hong Kong, Saint Martin, Qatar, Jordan, Romania, M…
      Submission number: K172875

  • 2019

    • 12 Dec 2019 Z-0915-2020 Class I Completed Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch. Distribution: U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT Submission number: K122715
Show all 14 recalls

  • 2016

    • 12 Jul 2016 Z-2550-2016 Class II Terminated Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask. Distribution: US nationwide distribution Submission number: K123979
    • 13 Jan 2016 Z-0746-2016 Class II Terminated Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. Distribution: Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT,…
      Full distribution text Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR.
      Submission number: K133868

  • 2015

    • 5 May 2015 Z-1750-2015 Class II Terminated The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm. Distribution: Worldwide distribution. US nationwide, Uruguay and Canada. Submission number: K133868

  • 2007

    • 23 Apr 2007 Z-1006-2007 Unclassified (pre-2012) Terminated S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sparks, smoke). Distribution: Worldwide, USA, Canada, and Mexico. Submission numbers: K033841, K041209

Frequently asked questions

How many devices does Resmed Corp have in the registry?

The registry currently lists 136 devices for Resmed Corp. Devices recorded under merged duplicate company entries are counted once.

Which registries list Resmed Corp's devices?

Among its 50 most recently registered devices, Resmed Corp has devices listed in EUDAMED (7 devices), FDA 510(k) (32 devices) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Resmed Corp's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Resmed Corp's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Resmed Corp?

FDA recall records list 14 recalls initiated by Resmed Corp, the most recent initiated on 25 Jun 2026. 9 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Resmed Corp?

EUDAMED lists 1 certificate for Resmed Corp (quality management system) under MDR. The most recent was issued on 29 May 2024.

What are the newest devices from Resmed Corp in the registry?

The most recently registered devices listed for Resmed Corp include AirView EU BOM, MYAIR EMEA IOS APP, EASYCARE TX 2 WEB DELIVERY and ORION 22291.

Generated automatically from registry data and not verified by a human reviewer.