| UTOPIA (K052249) | Respcare, Inc. | 2005-12-07 |
| SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL (K053248) | Electromed, Inc. | 2005-12-01 |
| POWERNEB (K051964) | Comedica , Inc. | 2005-12-01 |
| ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER (K051401) | I-Flow Corp. | 2005-11-30 |
| ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA (K052335) | Accutron, Inc. | 2005-11-23 |
| HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) (K053000) | Haemonetics Corp. | 2005-11-21 |
| KOKO LEGEND (K051572) | Pulmonary Data Services, Inc. | 2005-11-17 |
| AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER (K051226) | Cardinalhealth | 2005-11-17 |
| FLEXI-LITE, MODEL FL-V1.2 (K051759) | Performance Hyperbarics | 2005-11-17 |
| STIMUPLEX HNS-12, MODEL 4892098 (K052313) | Stockert GmbH | 2005-11-17 |
| INO THERAPEUTICS INOBLENDER, MODEL 10004 (K052663) | Ino Therapeutics | 2005-11-04 |
| SAFERSLEEP SYSTEM (K050883) | Safer Sleep, LLC | 2005-11-04 |
| TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 (K051583) | Tiara Medical Systems, Inc. | 2005-11-04 |
| DATEX-OHMEDA S/5 INTERFACE MODULE E-INT (K052880) | GE Healthcare | 2005-11-02 |
| RESPCARE FACE MASK (K052227) | Respcare, Inc. | 2005-10-28 |
| UNI-VENT MODEL 73X (K051476) | Impact Instrumentation, Inc. | 2005-10-28 |
| MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER (K052713) | Sechrist Industries, Inc. | 2005-10-28 |
| TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 (K051587) | Tracoe Medical GmbH | 2005-10-25 |
| INOGEN SATELLITE CONSERVER, MODEL SC-100 (K052563) | Medical Electronic Devices, Inc. | 2005-10-24 |
| EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR (K043520) | Emg Technology Co., Ltd. | 2005-10-21 |
| M-SERIES PRO CPAP SYTEM (K052110) | Respironics, Inc. | 2005-10-20 |
| LONGFEI LFY-I-5 OXYGEN CONCENTRATOR (K033405) | Zhejiang Longfei Industrial Co., Ltd. | 2005-10-18 |
| DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES (K052582) | GE Healthcare | 2005-10-14 |
| IISIS, VERSION 1.0 (K052244) | Innovision Medical Technologies, LLC | 2005-10-13 |
| ANDROFLOW - RESPIRATORY RATE MONITOR (K051779) | Andromed, Inc. | 2005-09-30 |
| CAREVENT ATV+ AND CAREVENT MRI (K051469) | O-Two Medical Technologies, Inc. | 2005-09-28 |
| GE DATEX-OHMEDA ENGSTROM CARESTATION (K051895) | Datex-Ohmeda, Inc. | 2005-09-27 |
| PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) (K051887) | Carleton Life Support Systems, Inc. | 2005-09-27 |
| I-NEB AAD SYSTEM (K042991) | Profile Therapeutics Plc | 2005-09-23 |
| AV-S ANAESTHESIA VENTILATOR (K051222) | Penlon Limited | 2005-09-23 |
| MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR (K052554) | Versamed Medical Systems, Inc. | 2005-09-23 |
| BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 (K051629) | Blease USA, Inc. | 2005-09-23 |
| INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR (K051540) | Inovo, Inc. | 2005-09-21 |
| AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER (K052332) | Trudell Medical Intl. | 2005-09-21 |
| OXY-SERVE II OXYGEN CONSERVING REGULATOR (K051988) | Superior Products, Inc. | 2005-09-21 |
| VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 (K051857) | Weissburg Associates | 2005-09-15 |
| BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER (K051313) | Salter Labs | 2005-09-15 |
| SCHUCO MIST AND SCHUCO DELUXE MIST (K051260) | Allied Healthcare Products, Inc. | 2005-09-15 |
| DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES (K052167) | GE Healthcare | 2005-09-08 |
| WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE (K052158) | Welch Allyn, Inc. | 2005-09-08 |
| CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 (K051279) | Caldyne, Inc. | 2005-09-07 |
| PRAXAIR MEDICAL AIR MIXER (K051192) | Praxair, Inc. | 2005-09-06 |
| MODEL 2800 PFT FILTER (K051712) | Air Safety, Ltd. | 2005-09-01 |
| CAREVENT CA AND DRA (K051889) | O-Two Medical Technologies, Inc. | 2005-08-30 |
| POLYTECH PULMONARY FUNCTION FILTER (K042758) | Polytechnic Resources, Inc. | 2005-08-29 |
| PVC AND SILICONE MANUAL RESUSCITATORS (K051177) | David Medical Products Co.,Ltd | 2005-08-29 |
| STINGRAY EPIDURAL CATHETER CONNECTOR (K051171) | Epimed International, Inc. | 2005-08-26 |
| GAV - GENERAL ANAESTHETIC VAPORIZER (K051666) | General Anaesthetic Services Limited | 2005-08-23 |
| FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 (K051860) | Epimed International, Inc. | 2005-08-22 |
| OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03 (K033863) | Ox-Gen, Inc. | 2005-08-22 |
| SILBRONCHO DOUBLE LUMEN TUBE (K051522) | Fuji Systems Corp. | 2005-08-17 |
| SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES (K050183) | Silvestrin Fabris S.R.L. | 2005-08-16 |
| VPAP ADAPT (K051364) | Resmed, Ltd. | 2005-08-16 |
| PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS (K051322) | Smiths Medical International , Ltd. | 2005-08-05 |
| MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR (K050430) | Merits Health Products Co., Ltd. | 2005-08-04 |
| AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (K050994) | Cardinalhealth | 2005-08-03 |
| RT019 INSPIRATORY/EXPIRATORY FILTER (K050927) | Fisher & Paykel Healthcare, Ltd. | 2005-08-01 |
| LTV 1000 VENTILATOR (K051767) | Pulmonetic Systems, Inc. | 2005-07-29 |
| COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 (K051365) | K-Jump Health Co., Ltd. | 2005-07-22 |
| ANEFIN, MODEL 100 (K033028) | Axon Medical | 2005-07-22 |
| SPIROTEL (K043528) | Mir Medical Intl. Research Srl | 2005-07-19 |
| DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES (K051635) | GE Healthcare | 2005-07-15 |
| RES TRAXX DATA CENTER (K051314) | Resmed, Ltd. | 2005-07-15 |
| AMSINO ENDOTRACHEAL TUBE (K050785) | Amsino International, Inc. | 2005-07-15 |
| CS MEDICAL TTCF GAS DELIVERY SYSTEM (K050381) | Cs Medical, Inc. | 2005-07-13 |
| CS MEDICAL ADULT TTCF CATHETER (K050379) | Cs Medical, Inc. | 2005-07-12 |
| EVITAXL WITH OPTION SMARTCARE (K051263) | Drager Medical AG & Co. Kgaa | 2005-07-12 |
| INSPIRATION VENTILATOR SYSTEM (K051550) | eVent Medical, Ltd. | 2005-07-12 |
| IMASK, MODELS 100, 200 AND 300 (K051559) | Vital Signs Colorado, Inc. | 2005-07-08 |
| ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 (K051262) | Respironics California, Inc. | 2005-07-08 |
| LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 (K051524) | Smiths Medical Asd, Inc. | 2005-07-07 |
| COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES (K043238) | Emg Technology Co., Ltd. | 2005-07-06 |
| PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES (K050803) | Vitaid, Ltd. | 2005-06-30 |
| AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE (K050953) | Air Safety, Ltd. | 2005-06-29 |
| ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 (K050424) | Fim Medical | 2005-06-23 |
| MD TURBO (K051284) | Respirics, Inc. | 2005-06-22 |
| GE DATEX-OHMEDA CENTIVA/5 VENTILATOR (K050860) | Datex-Ohmeda, Inc. | 2005-06-21 |
| THE INCOURAGE SYSTEM (K051383) | Respiratory Technologies, Incorporated | 2005-06-17 |
| SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA (K051416) | Mallinckrodt Medical | 2005-06-16 |
| ACCU02 SYSTEM (K051007) | Miti Corp. | 2005-06-16 |
| BIPAP AUTO (K050759) | Respironics, Inc. | 2005-06-15 |
| GOODKNIGHT 425ST (K050072) | Nellcor Puritan Bennett, Inc. | 2005-06-13 |
| KOO AMERICAS VALVE PEEP, MODEL KM-809 (K050918) | Koo Americas, Inc. | 2005-06-06 |
| AMT NANOCATH (K050557) | American Medical Technologies, Inc. | 2005-05-27 |
| PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (K050166) | Smiths Medical | 2005-05-26 |
| CPAP HUMIDIFIER, MODEL HC238JHU (K050904) | Fisher & Paykel Healthcare, Ltd. | 2005-05-25 |
| DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC (K051092) | GE Healthcare | 2005-05-25 |
| PROBLOC, HN SERIES AND PROLONG, PL SERIES (K050499) | Life-Tech, Inc. | 2005-05-17 |
| RESSCAN (K050775) | Resmed, Ltd. | 2005-05-10 |
| PIONEER U121 SERIES CPAP (K041823) | Merits Health Products Co., Ltd. | 2005-05-10 |
| IT NASAL MASK (K050171) | Innomed Technologies | 2005-05-04 |
| SPIRO'AIR (K042595) | Morgan Scientific, Inc. | 2005-05-04 |
| ATA HCM MONOPLACE HYPERBARIC SYSTEM (K040145) | Ata Hyperbaric Chamber Manufacturing | 2005-05-04 |
| PMP4 SPIROPRO (K050853) | Card Guard Scientific Survival , Ltd. | 2005-05-04 |
| REMREST HEATED HUMIDIFIER (K050990) | Medical Industries America, Inc. | 2005-05-02 |
| BABYPAC (K043495) | Smiths Medical International Ltd., Luton | 2005-04-22 |
| SPIRIT, MODEL HAS (K050153) | Caire, Inc. | 2005-04-15 |
| FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE (K043500) | Innospine, Inc. | 2005-04-15 |
| HOME-AWAY SYSTEM, MODEL 1041 (K042944) | In-X Corporation | 2005-04-15 |
| GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) (K050676) | Datex-Ohmeda, Inc. | 2005-04-12 |