| Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (K253479) | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 |
| OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun (K250651) | Fisher & Paykel Healthcare, Ltd. | 2025-11-19 |
| F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full (K252173) | Fisher & Paykel Healthcare, Ltd. | 2025-09-10 |
| F&P Optiflow Air/Oxygen Flow Source (K243917) | Fisher & Paykel Healthcare, Ltd. | 2025-07-14 |
| Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) (K251611) | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 |
| F&P Airvo 3 NIV (PT311US) (K233643) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| F&P Optiflow Flow Diverter (K234053) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) (K234058) | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 |
| F&P Optiflow Oxygen Kit (AA451J) (K233821) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 |
| F&P Optiflow+ Duet Nasal Cannula (K231956) | Fisher & Paykel Healthcare, Ltd. | 2024-02-07 |
| F&P 820 Humidification System (K223684) | Fisher & Paykel Healthcare, Ltd. | 2023-09-05 |
| F&P 950 Accessory Breathing Circuit Kits (K221436) | Fisher & Paykel Healthcare, Ltd. | 2023-06-29 |
| F&P Solo Mask Range (K223696) | Fisher & Paykel Healthcare, Ltd. | 2023-05-17 |
| F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (K222197) | Fisher & Paykel Healthcare, Ltd. | 2023-04-06 |
| F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (K212031) | Fisher & Paykel Healthcare, Ltd. | 2022-04-22 |
| F&P Evora Full Face Mask (K212371) | Fisher & Paykel Healthcare, Ltd. | 2022-03-18 |
| Optiflow Oxygen Kit (K211096) | Fisher & Paykel Healthcare, Ltd. | 2022-01-28 |
| F&P Visairo NIV Mask Range (K203449) | Fisher & Paykel Healthcare, Ltd. | 2021-04-14 |
| F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling (K201723) | Fisher & Paykel Healthcare, Ltd. | 2021-03-16 |
| F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model (K200089) | Fisher & Paykel Healthcare, Ltd. | 2020-06-02 |
| F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) (K191818) | Fisher & Paykel Healthcare, Ltd. | 2020-03-19 |
| F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) (K190713) | Fisher & Paykel Healthcare, Ltd. | 2019-10-11 |
| F&P SleepStyle (K173193) | Fisher & Paykel Healthcare, Ltd. | 2018-08-08 |
| F&P InfoSmart (K161686) | Fisher & Paykel Healthcare, Ltd. | 2017-01-24 |
| F&P Brevida™ Nasal Pillows Mask (K161412) | Fisher & Paykel Healthcare, Ltd. | 2017-01-18 |
| MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit (K143646) | Fisher & Paykel Healthcare, Ltd. | 2015-03-05 |
| HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT (K132017) | Fisher & Paykel Healthcare, Ltd. | 2014-03-25 |
| RT016 INSPIRATORY FILTER (K133666) | Fisher & Paykel Healthcare, Ltd. | 2014-02-05 |
| MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT (K131957) | Fisher & Paykel Healthcare, Ltd. | 2013-12-04 |
| AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER (K131895) | Fisher & Paykel Healthcare, Ltd. | 2013-10-24 |
| AIRVO HUMIDIFIER MYAIRO HUMIDIFIER (K121975) | Fisher & Paykel Healthcare, Ltd. | 2013-01-03 |
| ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS (K122432) | Fisher & Paykel Healthcare, Ltd. | 2012-12-06 |
| DUAL HEATED INFANT VREATHING CIROUITS (K103767) | Fisher & Paykel Healthcare, Ltd. | 2012-04-16 |
| RESPIRATORY HUMIDIFER (K110019) | Fisher & Paykel Healthcare, Ltd. | 2012-03-30 |
| INFOSEND GSM (K110316) | Fisher & Paykel Healthcare, Ltd. | 2011-08-19 |
| ZEST PETITE NASAL MASK (K103786) | Fisher & Paykel Healthcare, Ltd. | 2011-03-24 |
| FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (K100011) | Fisher & Paykel Healthcare, Ltd. | 2010-10-08 |
| RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 (K100554) | Fisher & Paykel Healthcare, Ltd. | 2010-05-28 |
| F&P ICON SERIES CPAP (K094040) | Fisher & Paykel Healthcare, Ltd. | 2010-04-27 |
| AIRVO SERIES HUMIDIFIERS (K092846) | Fisher & Paykel Healthcare, Ltd. | 2010-01-27 |
| ZEST NASAL MASK (K083832) | Fisher & Paykel Healthcare, Ltd. | 2009-03-16 |
| HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 (K083122) | Fisher & Paykel Healthcare, Ltd. | 2009-03-04 |
| SLEEPSTYLE 200 AUTO SERIES HC254 (K081029) | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 |
| FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK (K080209) | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 |
| RESPIRATORY HUMIDIFIER, MODEL MR850 (K073706) | Fisher & Paykel Healthcare, Ltd. | 2008-03-31 |
| OPUS HC482 DIRECT NASAL MASK (K063036) | Fisher & Paykel Healthcare, Ltd. | 2006-12-22 |
| FLEXIFIT HC432 FULL FACE MASK (K061236) | Fisher & Paykel Healthcare, Ltd. | 2006-08-29 |
| ACUTE CARE FACE MASK, MODEL RT040 (K060044) | Fisher & Paykel Healthcare, Ltd. | 2006-04-06 |
| RT019 INSPIRATORY/EXPIRATORY FILTER (K050927) | Fisher & Paykel Healthcare, Ltd. | 2005-08-01 |
| CPAP HUMIDIFIER, MODEL HC238JHU (K050904) | Fisher & Paykel Healthcare, Ltd. | 2005-05-25 |
| RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS (K034026) | Fisher & Paykel Healthcare, Ltd. | 2005-01-12 |
| HC604 CPAP HUMIDIFIER (K041900) | Fisher & Paykel Healthcare, Ltd. | 2004-08-31 |
| CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) (K040941) | Fisher & Paykel Healthcare, Ltd. | 2004-06-10 |
| FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A (K040506) | Fisher & Paykel Healthcare, Ltd. | 2004-05-05 |
| MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU (K033710) | Fisher & Paykel Healthcare, Ltd. | 2004-04-13 |
| PRESSURE MANIFOLD, MODEL BC 110 (K040366) | Fisher & Paykel Healthcare, Ltd. | 2004-03-04 |
| ORACLE ORAL MASK, MODEL HC451A (K033087) | Fisher & Paykel Healthcare, Ltd. | 2004-01-14 |
| RESPIRATORY HUMIDIFIER, MODEL MR850 (K020332) | Fisher & Paykel Healthcare, Ltd. | 2003-07-07 |
| SINGLE USE ORAL MASK, MODEL HC455A (K023670) | Fisher & Paykel Healthcare, Ltd. | 2003-06-12 |
| FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK (K023559) | Fisher & Paykel Healthcare, Ltd. | 2003-06-12 |
| SURGICAL PATIENT WARMER, MODEL PW820 JHU (K022609) | Fisher & Paykel Healthcare, Ltd. | 2003-03-06 |
| END EXPIRATORY FILTER, MODEL RT020 (K002839) | Fisher & Paykel Healthcare, Ltd. | 2001-10-04 |
| ORACLE ORAL MASK (K003894) | Fisher & Paykel Healthcare, Ltd. | 2001-06-25 |
| RESPIRATORY HUMIDIFIER, MODEL HC150 (K003973) | Fisher & Paykel Healthcare, Ltd. | 2001-06-01 |
| PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE (K002414) | Fisher & Paykel Healthcare, Ltd. | 2000-09-25 |
| RESPIRATORY HUMIDIFIER, MODEL # MR850 (K983112) | Fisher & Paykel Healthcare, Ltd. | 1998-11-10 |
| PATIENT WARMER- MODEL PW810 (K982636) | Fisher & Paykel Healthcare, Ltd. | 1998-10-26 |
| CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) (K953205) | Fisher & Paykel Healthcare, Ltd. | 1996-05-23 |
| MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER (K881970) | Fisher & Paykel Healthcare, Ltd. | 1989-03-09 |
| CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252 (K882438) | Fisher & Paykel Healthcare, Ltd. | 1988-07-18 |