| CHARTIS CATHETER MODEL CHR-CA-12.0 (K111522) | Pulmonx, Inc. | 2011-09-29 |
| ECHOBRIGHT (K111355) | Life-Tech, Inc. | 2011-09-16 |
| VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC (K103639) | Vortran Medical Technology 1, Inc. | 2011-09-15 |
| SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 (K102483) | Sunset Healthcare Solutions, LLC | 2011-09-13 |
| WATERPAP VALVE (K110713) | Airways Development, LLC | 2011-09-12 |
| ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 (K111116) | Datex-Ohmeda | 2011-09-09 |
| XTRA (K112245) | Sorin Group Italia S.R.L. | 2011-09-06 |
| COMP A-I-R (K110860) | Omron Healthcare, Inc. | 2011-09-02 |
| MORPHEUS OX (K111314) | Widemed, Ltd. | 2011-08-31 |
| MDRIVE (K111742) | Embla Systems | 2011-08-31 |
| SONO-SERIES CORNERSTONE TECHNIQUE (K111374) | PAJUNK GmbH Medizintechnologie | 2011-08-29 |
| WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL (K110269) | Well Lead Medical Co., Ltd. | 2011-08-26 |
| INFOSEND GSM (K110316) | Fisher & Paykel Healthcare, Ltd. | 2011-08-19 |
| V200 INTELLI-TRAK OPTION (K110795) | Respironics California, Inc. | 2011-08-19 |
| RSI 4200 (K102831) | Reimers Systems, Inc. | 2011-08-19 |
| SENTRYSUITE PRODUCT LINE (K111053) | Carefusion Germany 234 GmbH | 2011-08-12 |
| ACCUSOM (K110486) | Novasom, Inc. | 2011-08-12 |
| NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 (K102120) | Hsiner Co., Ltd. | 2011-08-12 |
| OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER (K110293) | Respironics New Jersey, Inc. | 2011-08-09 |
| BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 (K110383) | A Plus Medical | 2011-08-01 |
| VENNER TRACHEAL SEAL MONITOR (K110631) | Venner Medical (Singapore) Pte, Ltd. | 2011-07-28 |
| AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE (K111191) | Wet Nose Technologies, LLC | 2011-07-28 |
| CUFF SENTRY (K102674) | Ventlab Corp. | 2011-07-22 |
| SLEEPMINDER BREATHING FREQUENCY INDICATOR (K103631) | Biancamed Limited | 2011-07-21 |
| GE DATEX-OHMEDA AISYS (K110213) | Datex-Ohmeda, Inc. | 2011-07-20 |
| SEVOFLURANE VAPORIZER ADAPTOR (K110608) | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | 2011-07-20 |
| EASYFIT SILKGEL NASAL MASK (K110884) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-07-12 |
| PAINFUSOR CATHETER (K111031) | Plan 1 Health, S.R.L. | 2011-07-08 |
| APNEA RISK EVALUATION SYSTEM (ARES) (K111194) | Advanced Brain Monitoring, Inc. | 2011-07-07 |
| ATLANTEAN TRIGGER NEBULIZER (K102719) | Atlantean Corporation | 2011-07-01 |
| PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 (K103563) | Precision Medical, Inc. | 2011-07-01 |
| S8 ASPEN WITH H4I PLUS (K111148) | Resmed Corp | 2011-06-30 |
| INOMAX DSIR (DELIVERY SYSTEM) (K110344) | Ino Therapeutics | 2011-06-24 |
| INOMAX DS(IR) (DELIVERY SYSTEM) (K110635) | Ino Therapeutics, LLC/Dba Ikaria | 2011-06-23 |
| ACTIVE WASTE GAS SCAVENGER (K110930) | G. Dundas Co.,Inc. | 2011-06-23 |
| ANASCIENT BREATH MONITOR (K110810) | Invoy Technologies, LLC | 2011-06-21 |
| MEDLINE EPIDURAL AND SPINAL NEEDLES (K110194) | Medline Industries, Inc. | 2011-06-17 |
| PRESSURE MANOMETER (K110119) | Neoforce Group, Inc. | 2011-06-10 |
| NAVIGATOR APPLICATIONS SUITE (K102389) | GE Healthcare Finland Oy | 2011-06-10 |
| VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 (K102625) | Vega Technologies, Inc. | 2011-06-10 |
| AEROVENT PLUS CHC (K110273) | Monaghan Medical Corporation | 2011-06-09 |
| TRUBLUE NASAL MASK (K110405) | Respironics, Inc. | 2011-06-06 |
| WATCH-PAT 200S-3 (WP200S-3) (K102567) | Itamar Medical , Ltd. | 2011-06-02 |
| PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST (K103578) | Respironics Novametrix, LLC | 2011-06-02 |
| RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS (K110398) | Respironics, Inc. | 2011-06-01 |
| IQ VENTILATION NASAL MASK (K102317) | Sleepnet Corporation | 2011-05-17 |
| CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S (K103635) | Aerogen, Ltd. | 2011-05-13 |
| AVEA VENTILATOR (K103211) | Care Fusion | 2011-05-12 |
| MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 (K102182) | Maquet Critical Care AB | 2011-05-09 |
| APEX MEDICAL WIZARD SERIES CPAP MASK (K103174) | Apex Medical Corp. | 2011-05-06 |
| AGACHAMBER SPACER (K101348) | Aga Plastic Ind. Com. Ltda. | 2011-04-29 |
| PRECISION LIQUID OXYGEN SYSTEM (K103324) | Precision Medical, Inc. | 2011-04-21 |
| NEOPIP PATIENT CIRCUIT WITH PEEP (K103833) | Neoforce Group, Inc. | 2011-04-20 |
| RESUSCITATION UNIT 105 (K103317) | Atom Medical Corporation | 2011-04-20 |
| RESPICHAMBER VALVED HOLDING CHAMBER (K110136) | Trudell Medical Intl. | 2011-04-18 |
| APNEA RISK EVALUATION SYSTEM (ARES) (K110705) | Advanced Brain Monitoring, Inc. | 2011-04-14 |
| AMBIT TUNNELER (K110814) | Summit Medical Products, Inc. | 2011-04-08 |
| XVAC (K110782) | Sorin Group Italia S.R.L. | 2011-04-07 |
| UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR (K103318) | Impact Instrumentation, Inc. | 2011-04-07 |
| RESUSCI FLOW; RESUSCI FLOW 104 (K102542) | Atom Medical Corporation | 2011-04-06 |
| ISA CO2, ISA AX+, ISA OR+ (K103604) | Phasein AB | 2011-04-06 |
| V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS (K102985) | Respironics, Inc. | 2011-04-05 |
| NEOPAP SYSTEM (K103410) | Childrens Medical Ventures, LLC | 2011-03-30 |
| CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L (K101154) | Airsep Corp. | 2011-03-28 |
| WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (K101721) | Regulatory and Marketing Services, Inc. | 2011-03-24 |
| ZEST PETITE NASAL MASK (K103786) | Fisher & Paykel Healthcare, Ltd. | 2011-03-24 |
| PERFORMAX TOTAL FACE MASK (K103395) | Respironics, Inc. | 2011-03-24 |
| BIPAP AVAPS VENTILATORY SUPPORT SYSTEM (K102465) | Respironics, Inc. | 2011-03-24 |
| SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM (K110064) | Snap Diagnostics, LLC | 2011-03-18 |
| S9 VPAP ADAPT WITH H5I (K102586) | Resmed, Ltd. | 2011-03-18 |
| CPR FACE MASK (K102299) | Genuine First Aid, LLC | 2011-03-18 |
| LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 (K101792) | Linde Gas North America, LLC | 2011-03-18 |
| MIRAGE MICRO (K110444) | Resmed, Ltd. | 2011-03-16 |
| FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 (K101552) | Foshan Care Medical Technology Co., Ltd. | 2011-03-14 |
| NP15 (K102515) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-03-11 |
| EASY CUFF (K102704) | Joan Spiegel, MD | 2011-03-10 |
| MICRO DIARY SPIROMETER (K100928) | Viasys Respiratory Care, Inc. | 2011-03-07 |
| EZ-MISTER (K093584) | N.M. Beale Co., Inc. | 2011-03-04 |
| PULMOTRACK 2020 SYSTEM (K102229) | Karmelsonix | 2011-03-04 |
| SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION (K101850) | Spacelabs Healthcare, Ltd. | 2011-03-02 |
| STELLAR 150 (K103167) | Resmed Germany, Inc. | 2011-03-01 |
| GOLIFE NASAL MASK (K110008) | Respironics, Inc. | 2011-02-17 |
| STIMTRODE SINGLE USE NERVE STIMULATOR (K110118) | Xavant Technology (Pty), Ltd. | 2011-02-17 |
| AS3700 ANESTHSIA DELIVERY SYSTEM (K102471) | Mindray DS USA, Inc. | 2011-02-11 |
| O2-IN-A-BOX, O2-IN-A-BOX (K102750) | Geto2, Inc. | 2011-02-11 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) (K103345) | Breathe Technologies, Inc. | 2011-02-11 |
| MASTERSCREEN IOS (K101873) | Carefusion Germany 234 GmbH | 2011-02-10 |
| FLOWREST (K103316) | Vapotherm, Inc. | 2011-02-08 |
| CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P (K101439) | Codonics, Inc. | 2011-02-07 |
| FISIO CHAMBER SPACE (K101136) | Koo (Shanghai) Industries Co., Ltd. | 2011-01-28 |
| AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (K102824) | Ambu A/S | 2011-01-28 |
| VENTLAB 6000 SERIES HUMIDIFIER (K093617) | Ventlab Corp. | 2011-01-27 |
| FREQUENCER (K103176) | Dymedso, Inc. | 2011-01-26 |
| MODEL LTV 1100 VENTILATOR (K101643) | Care Fusion | 2011-01-26 |
| DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION (K100957) | Pacific Consolidated Industries, LLC | 2011-01-21 |
| HAMILTON-C2 (K102775) | Hamilton Medical AG | 2011-01-21 |
| IO-FLEX CATHETER (K102594) | Baxano, Inc. | 2011-01-19 |
| AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH (K102460) | Summit Medical Products, Inc. | 2011-01-13 |
| SMDIA-1000 (K101953) | Southmedic, Inc. | 2011-01-07 |
| NEOPOP INFANT RESUSCITATOR WITH FLOW METER (K102649) | Neoforce Group, Inc. | 2011-01-06 |