| RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (K082455) | Gulf Coast Hyperbarics, Inc. | 2009-05-22 |
| INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 (K083751) | Invacare Corporation | 2009-05-21 |
| EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 (K090356) | Allied Healthcare Products, Inc. | 2009-05-20 |
| BABI*PLUS BUBBLE PAP VALVE (K090317) | A Plus Medical | 2009-05-20 |
| MASTERSCREEN PAED - BABY BODY (K081823) | Viasys Healthcare GmbH | 2009-05-18 |
| BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS (K083507) | Allied Healthcare Products, Inc. | 2009-05-18 |
| RESPIRONICS SLEEPEASY CPAP SYSTEM (K091112) | Respironics, Inc. | 2009-05-15 |
| MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B (K083385) | Allied Healthcare Products, Inc. | 2009-05-14 |
| BREAS VIVO 40 SYSTEM (K090113) | Breas Medical AB | 2009-05-14 |
| REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM (K090243) | Respironics Inc., Sleep & Home Respiratory Group | 2009-05-08 |
| MIRAGE ECHO (K090490) | Resmed Corp | 2009-05-06 |
| ASTHMA MONITOR MODEL, AM1 (K090486) | Cardinal Health Germany 234 GmbH | 2009-05-06 |
| PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G (K090261) | Smiths Medical Asd, Inc. | 2009-05-01 |
| GE DATEX-OHMEDA S/5 ADU CARESTATION (K090892) | GE Healthcare Finland Oy | 2009-04-30 |
| CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V (K082038) | Clarus Medical, LLC | 2009-04-28 |
| APEX MEDICAL XT AUTO CPAP 9S-005200 (K083656) | Apex Medical Corp. | 2009-04-22 |
| SWIFT FX (K090244) | Resmed, Ltd. | 2009-04-13 |
| AEROCHAMBER MINI VENTILATION CHAMBER (K090065) | Trudell Medical Intl. | 2009-04-09 |
| PORTABLE OXYGEN UNIT SCA900 (K080243) | San Cheong Co. , Ltd. | 2009-04-07 |
| TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES (K090352) | Covidien | 2009-04-03 |
| PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 (K083693) | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009-04-02 |
| NAVIGATOR APPLICATIONS SUITE (K083098) | GE Healthcare Finland Oy | 2009-04-01 |
| SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM (K090722) | Shape Medical Systems, Inc. | 2009-03-31 |
| EVERON (K082465) | Earlysense, Ltd. | 2009-03-25 |
| COMFORTLITE NASAL MASK (K082558) | Respironics, Inc. | 2009-03-25 |
| CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR (K082853) | Inspired Technologies, Inc. | 2009-03-23 |
| RES TRAXX ONLINE, MODEL: R14 (K083816) | Resmed, Ltd. | 2009-03-20 |
| APNEALINK PLUS, MODEL: 22328 (K083575) | Resmed Germany, Inc. | 2009-03-19 |
| PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR (K083688) | Pulmonetic Systems, Inc. | 2009-03-18 |
| SPINAL INJECTION SYSTEM (K083909) | Laurimed, LLC | 2009-03-18 |
| IVENT101 (K081845) | Versamed Medical Systems, Inc. | 2009-03-16 |
| ZEST NASAL MASK (K083832) | Fisher & Paykel Healthcare, Ltd. | 2009-03-16 |
| OXYGEN DEMAND VALVE (K082345) | Bpr Medical, Ltd. | 2009-03-13 |
| TRILOGY 100 VENTILATOR (K083526) | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-13 |
| DYNAMIPEAK PEAK FLOW METER (K082899) | Dynamitech Medical, Inc. | 2009-03-10 |
| WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 (K082478) | Welch Allyn, Inc. | 2009-03-09 |
| SOMNOLYZER 24X7 (K083620) | The Siesta Group North America | 2009-03-06 |
| CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) (K081330) | O-Two Medical Technologies, Inc. | 2009-03-06 |
| MERCURY MEDICAL PEEP VALVE (K081266) | Mercury Enterprizes Dba Mercury Medical | 2009-03-05 |
| GE DATEX-OHMEDA AISYS (K090233) | Datex-Ohmeda, Inc. | 2009-03-05 |
| TRACH-ASSIST (K083702) | Mergenet Medical | 2009-03-05 |
| BIPAP AUTOSV (K090248) | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-04 |
| HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 (K083122) | Fisher & Paykel Healthcare, Ltd. | 2009-03-04 |
| PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS (K083451) | Smiths Medical Asd, Inc. | 2009-03-04 |
| NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P (K083456) | Nihon Kohden America, Inc. | 2009-03-02 |
| THE PFT FILTER (K083233) | Pulmonary Filtration Technologies, LLC | 2009-03-02 |
| BIVONA TRACHEOSTOMY TUBES (K083641) | Smiths Medical Asd, Inc. | 2009-02-23 |
| NEO-STAT CO2 <KG (K083056) | Mercury Medical | 2009-02-23 |
| INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) (K083879) | Innovision A/S | 2009-02-23 |
| ENDOTRACHEAL TUBE (K080105) | Chilecom Medical Devices Co., Ltd. | 2009-02-13 |
| STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 (K082772) | Life-Tech, Inc. | 2009-02-09 |
| REVOLUTIONFULL FACE MASK (K082866) | Respironics Inc., Sleep & Home Respiratory Group | 2009-01-30 |
| GALAXY (K083874) | Respironics Inc., Sleep & Home Respiratory Group | 2009-01-26 |
| MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED (K081536) | Medisize BV | 2009-01-23 |
| SPIRO-MASTER PC-10 SPIROMETRY SYSTEM (K080921) | Chest M.I., Inc. | 2009-01-21 |
| RESPIFIT S, MODEL RS-LR1001004 (K080299) | Eumedics Medizintechnik Und Marketing GmbH | 2009-01-13 |
| VPAP AUTO WITH HUMIDAIRE 3I (K082605) | Resmed, Ltd. | 2009-01-13 |
| V60 VENTILATOR, MODEL V8000 (K082660) | Respironics California, Inc. | 2009-01-09 |
| NEPTUNE HYPERBARIC VENTILATOR (K082351) | Level-5, Inc. | 2009-01-02 |
| S8 ADVANCE (K082979) | Resmed, Ltd. | 2009-01-02 |
| RESSCAN-PRO (K082983) | Resmed, Ltd. | 2009-01-02 |
| APNEICARE CONNECTION CENTER/INTERNET ANALYSIS (K082968) | Apneicare, LLC | 2009-01-02 |
| NEVONI CLASSIC, MODEL 6600-PO (K082878) | Nsr Comercio E Representacoes Ltda | 2008-12-30 |
| EVITE XL (K083050) | Draeger Medical AG & Co. KG | 2008-12-29 |
| AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) (K082829) | Carleton Life Support Systems, Inc. | 2008-12-22 |
| HEATER BASE, MODEL PMH7000 (K080149) | Pacific Medico Co., Ltd. | 2008-12-18 |
| COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM (K083413) | Philips Medical Systems | 2008-12-18 |
| MODIFICATION TO MINISPIR, SPIROLAB III (K082766) | Mir Medical Intl. Research Srl | 2008-12-17 |
| NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM (K082724) | Newport Medical Instruments, Inc. | 2008-12-16 |
| UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV (K071526) | Impact Instrumentation, Inc. | 2008-12-10 |
| HOLTER LX ANALYSIS (K081861) | North East Monitoring, Inc. | 2008-12-04 |
| MARK 5 NUVO LITE OCSI AND STD (K082566) | Nidek Medical Products, Inc. | 2008-12-03 |
| MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT (K082539) | Cardinal Health Germany 234 GmbH | 2008-12-02 |
| TABATABA COTESTER (K080278) | Fim Medical | 2008-11-28 |
| OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) (K082600) | Draeger Medical B.V. | 2008-11-26 |
| HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM (K082541) | Medi Nuclear Corp., Inc. | 2008-11-26 |
| ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 (K082655) | Envitec-Wismar GmbH | 2008-11-25 |
| EMG TRITON -COMP,MODEL NCA01-XXX SERIES (K072634) | Emg Technology Co., Ltd. | 2008-11-19 |
| TENACORE OXYGEN BLENDER, MODEL TB-2000 (K081335) | Tenacore Holdings, Inc. | 2008-11-14 |
| CUFFALERT (K081805) | Sunmed | 2008-11-14 |
| NOX T3, NOXTURNAL (PC APPLICATION) (K082113) | Nox Medical | 2008-11-07 |
| INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER (K082512) | Dimensional Dosing Systems, Inc. | 2008-11-07 |
| PB 540 VENTILATOR (K082966) | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2008-10-31 |
| TWINGUARD WITH CAPNOGRAPH ACCESSORY (K080527) | Trawax Pty Limited | 2008-10-31 |
| PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF (K082183) | PAJUNK GmbH Medizintechnologie | 2008-10-28 |
| DEVILBISS DV5M SMARTLINK SYSTEM (K082209) | Sunrise Medical | 2008-10-28 |
| PRECISION OXYGEN CONCENTRATOR (K072348) | Precision Medical, Inc. | 2008-10-27 |
| PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT (K082164) | PAJUNK GmbH Medizintechnologie | 2008-10-27 |
| MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) (K080339) | Medsource International, LLC | 2008-10-27 |
| PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C (K082923) | Life-Tech, Inc. | 2008-10-24 |
| AERONEB GO NEBULIZER (K081650) | Aerogen (Ireland), Ltd. | 2008-10-23 |
| SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT (K081404) | Spinal Integration, LLC | 2008-10-21 |
| DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE (K082092) | Galemed Corp. | 2008-10-15 |
| HELONTIX VENT (K072926) | Linde Gas Therapeutics | 2008-10-15 |
| THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK (K081670) | Cardinal Health 207, Inc. | 2008-10-09 |
| MODIFICATION TO MIRAGE MICRO (K081321) | Resmed, Ltd. | 2008-10-09 |
| PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST (K082237) | Mallinckrodt Developpement France | 2008-10-09 |
| RTX RESPIRATOR (K082657) | Medivent Limited | 2008-10-08 |
| FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO (K081447) | Draeger Medical AG & Co. KG | 2008-10-08 |
| TRACHEOSCOPIC VENTILATION TUBE (TVT) (K082420) | Etview | 2008-10-08 |