| PYTON (K092733) | Arm Medical Devices, Inc. | 2010-02-26 |
| BACT-TRAP HEPA MIDI (K093426) | Pharma Systems AB | 2010-02-22 |
| ALTERA NEBULIZER SYSTEM, MODEL 678G1002 (K100380) | Pari Respiratory Equipment, Inc. | 2010-02-22 |
| COMFORTGEL NASAL MASK (K092835) | Respironics Inc., Sleep & Home Respiratory Group | 2010-02-12 |
| POCKET BVM (K093081) | Microbvm Systems , Ltd. | 2010-02-05 |
| TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM (K093154) | Radiometer Medical Aps | 2010-02-05 |
| COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER (K091363) | Ag Industries | 2010-02-04 |
| PARI VIOS (K092918) | Pari Respiratory Equipment, Inc. | 2010-02-04 |
| EC50 MICRO+ SMOKERLYZER (K082315) | Bedfont Scientific, Ltd. | 2010-02-01 |
| TRILOGY 200 VENTILATOR (K093416) | Respironics, Inc. | 2010-01-29 |
| CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 (K091794) | Steve Islava | 2010-01-28 |
| EASYONE PRO RESPIRATORY ANALYSIS SYSTEM (K091428) | Ndd Medizitechnik AG | 2010-01-27 |
| AIRVO SERIES HUMIDIFIERS (K092846) | Fisher & Paykel Healthcare, Ltd. | 2010-01-27 |
| DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES (K093070) | Sunrise Medical | 2010-01-26 |
| METAPHOR METABOLIC MONITOR (K093080) | Treymed, Inc. | 2010-01-22 |
| BIPAP AVAPS VENTILATORY SUPPORT SYSTEM (K092818) | Respironics, Inc. | 2010-01-22 |
| ENDURAVENT-5 VENTILATOR (K092263) | Providence Global Medical, Inc. | 2010-01-21 |
| MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD (K093308) | Nidek Medical Products, Inc. | 2010-01-14 |
| ASTHMA MONITOR AM3 (K092890) | Carefusion Germany 234 GmbH | 2010-01-13 |
| AESPIRE 7900, AESPIRE VIEW (K092864) | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010-01-12 |
| CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS (K093469) | Cook, Inc. | 2010-01-08 |
| POGS, MODEL 65/130 (K092636) | On Site Gas Systems, Inc. | 2010-01-07 |
| LUNG FLUTE THERAPEUTIC (K091557) | Medical Acoustics | 2010-01-04 |
| MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES (K091541) | Sequal Technologies Co., Ltd. | 2009-12-31 |
| VPAP TX (K092186) | Resmed, Ltd. | 2009-12-22 |
| RESPIRONICS PERFORMAX SE TOTAL FACE MASK (K092648) | Respironics Inc., Sleep & Home Respiratory Group | 2009-12-18 |
| ATLANTIS HYPERBARIC CHAMBER VENTILATOR (K092264) | Providence Global Medical, Inc. | 2009-12-17 |
| AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM (K093260) | International Biomedical, Ltd. | 2009-12-16 |
| ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE (K093525) | Ventlab Corp. | 2009-12-10 |
| STIMPOD MODEL NMS-400 NERVE STIMULATOR (K093591) | Xavant Technology (Pty), Ltd. | 2009-12-03 |
| RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC (K091111) | Instrumentation Industries, Inc. | 2009-12-02 |
| PNEUMOTHERML, MODEL: 5800 (K092685) | Salter Labs | 2009-11-24 |
| AXS-590 SERIES (K091650) | Swr International, Ltd. | 2009-11-24 |
| MODIFICATION TO IVENT 101 (K092135) | Versamed Medical Systems , Ltd. | 2009-11-23 |
| VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER (K092687) | A Plus Medical | 2009-11-23 |
| NESSI SPACER (K091862) | Pharmacaribe | 2009-11-20 |
| STERILE WATER FOR INHALATION FLEX BAG, USP (K090915) | Cardinal Health, Inc. | 2009-11-18 |
| NEWPORT HT70 FAMILY OF VENTILATORS (K090888) | Newport Medical Instruments, Inc. | 2009-11-18 |
| AKITA JET (K090730) | Activaero America, Inc. | 2009-11-13 |
| BESMED JET NEBULIZER BOTTLE SET (K091272) | Besmed Health Business Corp | 2009-11-10 |
| NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD (K090804) | Innomed Technologies, Inc./Respcare, Inc. | 2009-11-05 |
| EPIFUSE CATHETER CONNECTOR, MODEL: 4909E (K092657) | Smiths Medical Asd, Inc. | 2009-11-04 |
| SLEEPWEAVER NASAL CPAP MASK (K092362) | Circadiance, LLC | 2009-11-02 |
| BIPAP AUTOSV ADVANCED (K090539) | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-30 |
| TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT (K091761) | Teleflexmedical, Inc. | 2009-10-29 |
| DK50 DS (K091871) | Ekom S.R.O. | 2009-10-23 |
| GAS TRANSFILL (K091191) | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-23 |
| OMNI 2 OXYGEN SYSTEM (K083163) | Sequal Technologies, Inc. | 2009-10-20 |
| BD SPINAL NEEDLE 27G (K091758) | Becton Dickson & Co. | 2009-10-09 |
| SMARTTRACK SYSTEM (K091803) | Nexus6, Ltd. | 2009-10-09 |
| ISPIRA RESUSCITATION UNIT (K092085) | Neoforce Group, Inc. | 2009-10-07 |
| FLEXICARE BREATHING FILTERS (K092218) | Flexicare Medical, Ltd. | 2009-10-06 |
| EASYCARE TX, TX LINK (K092026) | Resmed, Ltd. | 2009-10-02 |
| CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE (K092003) | MyCardio, LLC | 2009-09-30 |
| S8 ASPEN WITH H4I PLUS (K091947) | Resmed, Ltd. | 2009-09-28 |
| DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST (K091919) | Sunrise Medical | 2009-09-28 |
| LAURIMED SPINAL INJECTION SYSTEM (K091818) | Laurimed, LLC | 2009-09-23 |
| PERSONAL WHEEZOMETER (K090863) | Karmelsonix | 2009-09-21 |
| WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 (K091853) | Nspire Health, Inc. | 2009-09-21 |
| ESOPHAGEAL STETHOSCOPE (K092716) | Truer Medical, Inc. | 2009-09-17 |
| COMFORT TWIN NASAL MASK (K091843) | Respironics Inc., Sleep & Home Respiratory Group | 2009-09-10 |
| YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B (K083559) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2009-09-04 |
| COMFORT TWIN NASAL MASK (K091066) | Respironics Inc., Sleep & Home Respiratory Group | 2009-09-03 |
| ASCEND (K091155) | Neurometrix, Inc. | 2009-09-03 |
| MERCURY VCO2 (K092217) | Respironics Novametrix, Inc. | 2009-08-21 |
| CLEAN PEAK FLOW METER (K091412) | Viasys Healthcare GmbH | 2009-08-21 |
| MERCURY CPAP (K090710) | Mercury Medical | 2009-08-20 |
| PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (K083031) | Smiths Medical Asd, Inc. | 2009-08-18 |
| B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET (K090995) | B.Braun Medical, Inc. | 2009-08-14 |
| BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE (K091461) | Cardiopulmonary Corp. | 2009-08-14 |
| UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ (K091238) | Impact Instrumentation, Inc. | 2009-08-13 |
| HELIO2 BLENDER (K090781) | Precision Medical, Inc. | 2009-08-13 |
| BIPAP SYNCHRONY 2 (K092043) | Respironics, Inc. | 2009-08-05 |
| EZC MEDICAL, LLC INTUBAIDFLEX (K090777) | Ezc Medical, LLC | 2009-08-04 |
| QUATTRO LT (K091129) | Resmed, Ltd. | 2009-08-03 |
| REMSTAR AUTO A-FLEX (K091319) | Respironics Inc., Sleep & Home Respiratory Group | 2009-08-03 |
| PHILIPS NM3 MONITOR, MODEL 7900 (K091459) | Respironics Novametrix, LLC | 2009-07-28 |
| THERMOFLO HCH, THERMOFLO FILTER (K090738) | Arc Medical, Inc. | 2009-07-27 |
| JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 (K090007) | Danyang Jumao Healthcare Equipment Co., Ltd. | 2009-07-24 |
| 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER (K091185) | Hsiner Co., Ltd. | 2009-07-24 |
| CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 (K090646) | Chest M.I., Inc. | 2009-07-23 |
| OMNI 5 TOTAL O2 DELIVERY SYSTEM (K091028) | Respironics, Inc. | 2009-07-23 |
| PARI PEP S (K090829) | Pari Respiratory Equipment, Inc. | 2009-07-21 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (K082982) | Breathe Technologies, Inc. | 2009-07-20 |
| MINIME PEDIATRIC MASK (K090935) | Sleepnet Corporation | 2009-07-01 |
| PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. (K090884) | B.Braun Medical, Inc. | 2009-06-29 |
| ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 (K083256) | K-Jump Health Co., Ltd. | 2009-06-26 |
| ALICE PDX (K090484) | Respironics Inc., Sleep & Home Respiratory Group | 2009-06-26 |
| PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 (K083119) | Smiths Medical Asd, Inc. | 2009-06-26 |
| CHARTIS CONSOLE (K083199) | Pulmonx, Inc. | 2009-06-25 |
| CHARTIS CATHETER (K083883) | Pulmonx, Inc. | 2009-06-25 |
| VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. (K090840) | Ventlab Corp. | 2009-06-25 |
| DDI ULTRASONIC NEBULIZER SYSTEM (K090307) | Diagnostic Devices, Inc. | 2009-06-18 |
| INOMAX DS (DELIVERY SYSTEM) (K090958) | Ino Therapeutics, LLC | 2009-06-18 |
| FLEXICARE MEDICAL ENDOTRACHEAL TUBES (K091591) | Flexicare Medical, Ltd. | 2009-06-17 |
| HAMILTON-C2 (K090468) | Hamilton Medical AG | 2009-06-15 |
| KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 (K090273) | Kai Sensors, Inc. | 2009-06-05 |
| EASY ON-PC SPIROMETER (K090034) | Ndd Medizitechnik AG | 2009-06-02 |
| RESPIRONICS PERFORMAX TOTAL FACE MASK (K091271) | Respironics Inc., Sleep & Home Respiratory Group | 2009-05-29 |
| MODEL 350G GAS CONSERVER (K090421) | Inspired Technologies, Inc. | 2009-05-29 |