| EASYCARE ONLINE (K123557) | Resmed, Ltd. | 2013-03-14 |
| FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS (K121747) | Intersurgical Incorporated | 2013-03-14 |
| K SERIES CPAP SYSTEMS (K123897) | Curative Medical, Inc. | 2013-03-13 |
| PULMOSAL (K130091) | Pharmacaribe | 2013-03-13 |
| SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) (K123614) | Trudell Medical Intl. | 2013-03-11 |
| KANGAROO NASAL MASK (K122847) | Respironics, Inc. | 2013-03-06 |
| U-RIGHT COMPRESSOR NEBULIZER (K121969) | Taidoc Technology Corporation | 2013-02-28 |
| CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES (K123195) | GE Healthcare Finland Oy | 2013-02-28 |
| MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD (K123738) | Nidek Medical Products, Inc. | 2013-02-28 |
| VITAL 5 RELEAF CATHETER (K122661) | Vital 5 | 2013-02-27 |
| QUATTRO AIR (K123979) | Resmed, Ltd. | 2013-02-27 |
| ZI BLOWER (K121374) | Deshum Medical | 2013-02-22 |
| COMFORT COUGH (K113549) | Seoil Pacific Corp. | 2013-02-21 |
| EMBLETTA MPR (K122516) | Embla Systems | 2013-02-21 |
| A5 ANESTHESIA DELIVERY SYSTEM (K123211) | Datascope Corp., Patient Monitoring Division | 2013-02-14 |
| ISO-GARD CLEARAIR MASK (K123176) | Teleflexmedical, Inc. | 2013-02-14 |
| PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K130043) | Teleflexmedical, Inc. | 2013-02-12 |
| GE DATEX-OHMEDA AVANCE CS2 (K123125) | Datex-Ohmeda, Inc. | 2013-02-06 |
| ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (K122290) | Envitec-Wismar GmbH | 2013-01-23 |
| MANOMETER (K122077) | Intersurgical, Inc. | 2013-01-10 |
| AIRVO HUMIDIFIER MYAIRO HUMIDIFIER (K121975) | Fisher & Paykel Healthcare, Ltd. | 2013-01-03 |
| RESPIRONICS SIMPLYCLEAR DEVICE (K122111) | Respironics, Inc. | 2012-12-31 |
| HAMILTON-C3 (K123637) | Hamilton Medical AG | 2012-12-21 |
| ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (K122690) | Arrow International, Inc. | 2012-12-21 |
| ANESTHESIA CONDUCTION NEEDLES (K120475) | Shanghai Samedical & Plastic Instruments Co., Ltd. | 2012-12-21 |
| DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER (K122075) | Intersurgical, Inc. | 2012-12-20 |
| KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (K120985) | Kimberly-Clark Corp. | 2012-12-19 |
| EVOLUTION 3E VENTILATOR (K113743) | Event Medical, Inc. | 2012-12-18 |
| COUGHASSIST T70 DEVICE (K121955) | Respironics, Inc. | 2012-12-14 |
| BIPAP A 40 VENTILATORY SUPPORT SYSTEM (K121623) | Respironics, Inc. | 2012-12-14 |
| QUARK SERIES (K120146) | Cosmed Srl | 2012-12-11 |
| PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM (K120953) | Tlelflex Medical, Inc. | 2012-12-10 |
| WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] (K121382) | Westmed, Inc. | 2012-12-06 |
| APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 (K112079) | Apex Medical Corp. | 2012-12-06 |
| ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS (K122432) | Fisher & Paykel Healthcare, Ltd. | 2012-12-06 |
| HARD SHELL VENTED NASAL MASK (K121321) | Sleepnet Corporation | 2012-11-30 |
| MICROSTREAM FILTERLINE ICU (K121927) | Oridion Medical 1987 , Ltd. | 2012-11-29 |
| CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE (K121846) | B.Braun Medical, Inc. | 2012-11-20 |
| SENTRYSUITE PRODUCT LINE (K122699) | Carefusion Germany 234 GmbH | 2012-11-19 |
| HAMILTON-C2 (K121225) | Hamilton Medical AG | 2012-11-16 |
| VPAP S-A (K122324) | Resmed, Ltd. | 2012-11-13 |
| NEWPORT AURA VENTILATOR (K121891) | Newport Medical Instruments, Inc. | 2012-11-09 |
| INOBLENDER (K122689) | Ino Therapeutics | 2012-11-07 |
| HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 (K122857) | Pegasus Research Corp. | 2012-11-07 |
| MINIME 2 NASAL MASK (K121692) | Sleepnet Corporation | 2012-11-05 |
| FLO-GUARD BREATHING FILTER (K121026) | Intersurgical, Inc. | 2012-11-02 |
| TAP PAP NASAL PILLOW MASK (K122350) | Airway Management, Inc. | 2012-11-01 |
| COSENSE (K121768) | Capnia, Inc. | 2012-10-31 |
| IRMA C02 MODEL 200101; IRMA AX 200601 (K123043) | Phasein AB | 2012-10-25 |
| ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM (K122262) | Haemonetics Corp. | 2012-10-25 |
| OMNI 3 OXYGEN SYSTEM (K120785) | Caire, Inc. | 2012-10-25 |
| GEO (K121705) | Resmed, Ltd. | 2012-10-23 |
| AESPIRE 7900, AESPIRE VIEW (K122445) | Datex-Ohmeda | 2012-10-12 |
| PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY (K121379) | Airon Corporation | 2012-10-11 |
| REMSTAR SE (K122769) | Respironics, Inc. | 2012-10-09 |
| SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T (K122531) | Covidien | 2012-10-09 |
| SIMPLE T NASAL MASK (K121631) | Respironics, Inc. | 2012-10-05 |
| MINISPIR (K122384) | Mir Medical Intl. Research Srl | 2012-10-04 |
| ESON NASAL MASK (K121597) | Fisher & Paykel Healthcare Limited | 2012-10-02 |
| EZ-BLOCKER (K121462) | Ez-Blocker B.V. | 2012-09-28 |
| EASYONE PRO RESPIRATORY TESTING DEVICE (K120635) | Ndd Medizitechnik AG | 2012-09-27 |
| EXSPIRON (K120087) | Respiratory Motion, Inc. | 2012-09-26 |
| INOMAX DS (DELIVERY SYSTEM) (K121021) | Ino Therapeutics | 2012-09-24 |
| TROOPER OXYGEN CONCENTRATOR (K121260) | Vbox, Inc. | 2012-09-21 |
| HUMID-VENT HEPA (K112958) | Teleflex Medical | 2012-09-21 |
| CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT (K110053) | Smiths Medical Asd, Inc. | 2012-09-14 |
| VITAL COUGH (K120277) | Lung Assist, Inc. | 2012-09-12 |
| ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER (K122027) | Arrow International, Inc. | 2012-08-28 |
| PICIS WEIGHT BASED DOSE CONVERTER (K121542) | Picis, Inc. | 2012-08-27 |
| ULTRASONIC NEBULIZER (K121154) | Foshan Gaunying Electronics Co., Ltd. | 2012-08-20 |
| MEDICAL AIR COMPRESSOR (K113338) | Oricare, Inc. | 2012-08-10 |
| SPIRALE DRUG DELIVERY SYSTEM (K111246) | Armstrong Medical , Ltd. | 2012-08-10 |
| PERIFUSE CATHETER (K121525) | Smiths Medical Asd, Inc. | 2012-08-02 |
| MOJO, VERASEAL (K120463) | Sleepnet Corporation | 2012-07-27 |
| O2PAK OXYGEN GENERATOR (K120566) | Pacific Precision Products | 2012-07-24 |
| BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE (K111401) | Hangzhou Bever Medical Devices Co., Ltd. | 2012-07-19 |
| CAPNOSTREAM20P WITH AI/ODI (K112368) | Oridion Medical 1987 , Ltd. | 2012-07-19 |
| BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) (K111406) | Hangzhou Bever Medical Devices Co., Ltd. | 2012-07-19 |
| A&J 5L POCA SERIES OXYGEN CONCENTRATOR (K121531) | Zhongshan A&J Medical Equipment Co., Ltd. | 2012-07-17 |
| PERFORMAX PEDIATRIC EE TOTAL FACE MASK (K120562) | Respironics, Inc. | 2012-07-17 |
| HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA (K120920) | Hsiner Company | 2012-07-16 |
| CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR (K112840) | Seebreath AB | 2012-07-13 |
| CAPNOGRAPHY PAD (92516) (K121017) | Spacelabs Healthcare | 2012-07-13 |
| RESIN 11 (K121170) | Respinnovation Sas | 2012-07-13 |
| AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) (K112010) | Trudell Medical Intl. | 2012-07-11 |
| PERFORMAX PEDIATRIC SE TOTAL FACE MASK (K120639) | Respironics, Inc. | 2012-07-10 |
| FLIGHT 60 VENTILATOR (K120726) | Flight Medical Innovations , Ltd. | 2012-07-06 |
| ASTHMAPOLIS SYSTEM (K121609) | Reciprocal Labs Corporation | 2012-07-02 |
| K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER (K120285) | Curative Medical, Inc. | 2012-07-02 |
| MOUNTED MEDICAL OXYGEN SYSTEM (K113767) | Essex Industries, Inc. | 2012-06-29 |
| ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) (K121028) | Etview , Ltd. | 2012-06-21 |
| QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER (K112824) | Quality Life Technologies Co;Ltd | 2012-06-21 |
| AIRTRAQ SP AIRTRAQ AVANT (K121378) | Prodol Meditec , Ltd. | 2012-06-21 |
| CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET (K121403) | Teleflex, Inc. | 2012-06-20 |
| SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML (K113033) | Nephron Pharmaceuticals Corp. | 2012-06-19 |
| IVENT101 (K112754) | Versamed Medical Systems , Ltd. | 2012-06-15 |
| BLEASE700/900 SERIES VENTILATORS (K112729) | Spacelabs Healthcare | 2012-06-11 |
| VIVA EB (K120334) | Etview , Ltd. | 2012-06-08 |
| EARLYSENSE (EVERON) SYSTEM (K120465) | Earlysense, Ltd. | 2012-06-08 |
| ERAPID NEBULIZER SYSTEM (K112859) | Pari Respiratory Equipment, Inc. | 2012-05-30 |