| S9 VPAP ST WITH H5I (K102513) | Resmed, Ltd. | 2011-01-05 |
| MIRAGE FX (K102746) | Resmed, Ltd. | 2010-12-28 |
| V200 VENTILATOR (K102054) | Respironics California, Inc. | 2010-12-22 |
| PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, (K102007) | Life-Tech, Inc. | 2010-12-22 |
| GOLIFE NASAL MASK (K102502) | Respironics, Inc. | 2010-12-22 |
| CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER (K103392) | Inovo, Inc. | 2010-12-17 |
| STIMPOD NMS450 NERVE STIMULATOR (K102084) | Xavant Technology (Pty), Ltd. | 2010-12-16 |
| PIXI PEDIATRIC MASK (K102224) | Resmed, Ltd. | 2010-12-10 |
| VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED (K102618) | Draeger Medical AG & Co. KG | 2010-12-10 |
| MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS (K102658) | Thayer Medical Corp. | 2010-12-10 |
| NEUMOVENT GRAPHNET MODEL 3179L1V (K101401) | Tecme S.A. | 2010-12-07 |
| SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE (K101690) | Sentec AG | 2010-12-03 |
| HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM (K101907) | Haemonetics Corp. | 2010-12-03 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) (K102525) | Breathe Technologies, Inc. | 2010-12-02 |
| MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES (K100920) | Sequal Technologies Co., Ltd. | 2010-11-29 |
| PREASSEMBLED SURGICAL WASH SET (K103202) | Sorin Group Italia S.R.L. | 2010-11-23 |
| VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 (K102377) | A Plus Medical | 2010-11-18 |
| NIVO NEBULIZER SYSTEM (K102240) | Aerogen Ireland, Ltd. | 2010-11-10 |
| CARE ZY5BA OXYGEN CONCENTRATOR (K102245) | Foshan Care Medical Technology Co., Ltd. | 2010-11-09 |
| INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER (K092451) | Intersurgical, Inc. | 2010-10-29 |
| THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 (K092256) | Smiths Medical Asd, Inc. | 2010-10-20 |
| VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 (K100687) | Vitalograph (Ireland) , Ltd. | 2010-10-16 |
| FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (K100011) | Fisher & Paykel Healthcare, Ltd. | 2010-10-08 |
| XTRA AUTOTRANSFUSION SYSTEM (K101586) | Sorin Group Italia S.R.L. | 2010-10-05 |
| REVIVATOR (K094003) | Hersill, S.L. | 2010-09-17 |
| ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK (K101129) | Respironics, Inc. | 2010-09-16 |
| RXPEAKFLOW (K101380) | Noble Marketing | 2010-09-13 |
| NEWPORT E360 VENTILATOR (K101803) | Newport Medical Instruments, Inc. | 2010-09-08 |
| BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK (K101130) | Respironics, Inc. | 2010-09-02 |
| NESSI OTC SPACER (K101532) | Pharmacaribe | 2010-09-01 |
| FREQUENCER MODEL V2X (K100749) | Dymedso, Inc. | 2010-08-31 |
| ENDOTRACHEAL TUBE CHANGERS (K102127) | Instrumentation Industries, Inc. | 2010-08-27 |
| FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE (K101728) | Cook, Inc. | 2010-08-25 |
| MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (K101272) | Essex Industries, Inc. | 2010-08-20 |
| FLIGHT 60 VENTILATOR, MODEL F-60 (K100753) | Flight Medical , Ltd. | 2010-08-20 |
| PHARMACARIBE INHALED SALINE SOLUTIONS (K101424) | Pharmacaribe | 2010-08-17 |
| O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (K092991) | Environmental Tectonics Corp. | 2010-08-13 |
| BUSSE EPIDURAL CATHETER KIT (K093920) | Busse Hospital Disposables | 2010-08-06 |
| VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (K092029) | Draeger Medical AG & Co. KG | 2010-08-06 |
| CPR MASK (K083418) | Firstar Healthcare Co., Ltd. | 2010-07-22 |
| RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V (K101857) | Instrumentation Industries, Inc. | 2010-07-22 |
| ASTRASONIC SPIROMETER, MODEL 29-8000 (K092813) | Sdi Diagnostics, Inc. | 2010-07-16 |
| MODEL 300157 CPAP SYSTEM (K100121) | Aeiomed, Inc. | 2010-07-13 |
| VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (K100950) | Venner Medical (Singapore) Pte, Ltd. | 2010-07-13 |
| FIL 1520 (K101629) | Glenn Medical Systems, Inc. | 2010-07-09 |
| MERITS MODEL N SERIES NEBULIZER COMPRESSORS (K092859) | Merits Health Products Co., Ltd. | 2010-07-02 |
| LITETOUCH MASK (K100285) | Respironics New Jersey, Inc. | 2010-06-29 |
| G+ SYSTEM (K101344) | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010-06-28 |
| SHIKANI SPEAKING VALVE (K100995) | Shikani Medical, LLC | 2010-06-25 |
| ECHOBRIGHT (K093662) | Life-Tech, Inc. | 2010-06-24 |
| KAI SPOT MODEL KMS 200 (K100773) | Kai Medical, Inc. | 2010-06-23 |
| ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH (K100480) | Vitaltec Corporation | 2010-06-11 |
| FLEXI-LITE (K101262) | Pressure-Tech, Inc. | 2010-06-10 |
| MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) (K100772) | Resmed, Ltd. | 2010-06-09 |
| PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE (K100546) | Parkermedicalinc | 2010-06-03 |
| RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 (K100554) | Fisher & Paykel Healthcare, Ltd. | 2010-05-28 |
| EVERON 1.0 (K092062) | Earlysense, Ltd. | 2010-05-24 |
| INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 (K092129) | Intersurgical, Inc. | 2010-05-18 |
| BABI PLUS INFANT NASAL CANNULA SYSTEM (K093716) | A Plus Medical | 2010-05-13 |
| CAPNOSTREAM20 WITH MICROMEDICO2 MODULE (K094012) | Oridion Capnography, Inc. | 2010-05-12 |
| TRILOGY 202 VENTILATOR (K093905) | Respironics, Inc. | 2010-05-12 |
| VELA VENTILATOR (K093094) | Cardinal Health 207, Inc. | 2010-05-11 |
| PARI SINUS (K092560) | Pari Respiratory Equipment, Inc. | 2010-05-06 |
| CAREVENT HANDHELD CPAP SYSTEM (K093862) | O-Two Medical Technologies, Inc. | 2010-05-06 |
| ENGSTROM CARESTATION, ENGSTROM PRO (K093886) | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010-05-03 |
| SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 (K092611) | Sonarmed, Inc. | 2010-04-28 |
| F&P ICON SERIES CPAP (K094040) | Fisher & Paykel Healthcare, Ltd. | 2010-04-27 |
| SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (K100268) | Sechrist Industries, Inc. | 2010-04-26 |
| PAP-CAP (K100343) | Pur-Sleep, Inc. | 2010-04-23 |
| VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC (K100283) | Cook, Inc. | 2010-04-23 |
| INFINITY MCABLE - MAINSTREAM CO2 (K100941) | Draeger Medical AG & Co. KG | 2010-04-23 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S (K100528) | Breathe Technologies, Inc. | 2010-04-23 |
| AMBU ASCOPE AND MONITOR (K093186) | Ambu A/S | 2010-04-16 |
| VAPOR-CLEAR, MODEL 100 (K092031) | Axon Medical, Inc. | 2010-04-16 |
| CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 (K100241) | B.Braun Medical, Inc. | 2010-04-16 |
| INOMAX DS (K093922) | Ino Therapeutics | 2010-04-15 |
| HYBERNITE RAINOUT CONTROL SYSTEM (K100104) | Plastiflex Group NV | 2010-04-14 |
| PEAK EXPIRATORY FLOW METER, KN-9710 (K092335) | K-Jump Health Co., Ltd. | 2010-04-09 |
| MERCURY MEDICAL T-PIECE RESUSCITATOR (K093913) | Mercury Medical, Inc. | 2010-04-06 |
| INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE (K093632) | Drager Medical AG & Co. Kgaa | 2010-04-05 |
| HELIOX LOW FLOW SENTRY BLENDER (K092484) | Cardinal Health 207, Inc. | 2010-04-02 |
| MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY (K091716) | Merits Health Products Co., Ltd. | 2010-04-02 |
| VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE (K093135) | Venner Medical (Singapore) Pte, Ltd. | 2010-04-02 |
| INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE (K093633) | Draegerwerk AG & CO Kgaa | 2010-03-30 |
| MOVES (K093261) | Thornhill Research, Inc. | 2010-03-26 |
| PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 (K091538) | Wet Nose Technologies, LLC | 2010-03-25 |
| VPAP III ST-A (K093731) | Resmed, Ltd. | 2010-03-22 |
| AUTOLOG AUTOTRANSFUSION SYSTEM (K093535) | Medtronic, Inc. | 2010-03-22 |
| COOPDECH ENDOBRONCHIAL BLOCKER TUBE (K093888) | Daiken Medical Co, Ltd. | 2010-03-16 |
| 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION (K092847) | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2010-03-11 |
| WELL LEAD ENDOBRONCHIAL TUBES (K092886) | Well Lead Instruments | 2010-03-11 |
| PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 (K093124) | Cardinal Health 207, Inc. | 2010-03-10 |
| HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER (K092409) | Intersurgical, Inc. | 2010-03-10 |
| INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K092545) | Ino Therapeutics, LLC | 2010-03-10 |
| HAMILTON-C2 (K092148) | Hamilton Medical AG | 2010-03-04 |
| SMART CAPNOLINE GUARDIAN (K093388) | Oridion Medical 1987 , Ltd. | 2010-03-04 |
| ANAPNOGUARD ENDOTRACHEAL TUBE (K093126) | Hospitech Respiration , Ltd. | 2010-03-02 |
| FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE (K093209) | Cook, Inc. | 2010-02-26 |
| SPIROPALM (K093174) | Cosmed Srl | 2010-02-26 |
| EASYCARE ONLINE (K093684) | Resmed, Ltd. | 2010-02-26 |