| MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K041223) | Maquet Critical Care AB | 2004-07-29 |
| PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C (K041664) | On Site Gas Systems, Inc. | 2004-07-29 |
| CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET (K041044) | Cook, Inc. | 2004-07-29 |
| GOODKNIGHT 425, MODELM-114500-00 (K041819) | Mallinckrodt Developpement France | 2004-07-22 |
| AMBU DISPOSABLE PRESSURE MANOMETER (K040991) | Ambu, Inc. | 2004-07-22 |
| EOCD (K041568) | Respironics, Inc. | 2004-07-21 |
| MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES (K041327) | Med2000 S.R.L. | 2004-07-20 |
| MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM (K033897) | Aga-Linde Health Care | 2004-07-19 |
| MERLIN RESUSCITATOR (K031395) | Merlin Medical Limited | 2004-07-16 |
| RESMED HOSPITAL FULL FACE MASK (K041362) | Resmed, Ltd. | 2004-07-15 |
| VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM (K041473) | Vortran Medical Technology 1, Inc. | 2004-07-15 |
| OXYGEN MEDICELS, CITICELS (K041773) | City Technology Limited | 2004-07-15 |
| PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA (K041348) | Smiths Medical | 2004-07-13 |
| BAWMED RESCUE MASK (K031431) | Bawmed UK | 2004-07-13 |
| MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (K041622) | Draeger Medical, Inc. | 2004-07-08 |
| MDI TRIGGER GUARD (K040439) | North American Technical Services (Nats) Corp. | 2004-07-08 |
| RESMED S8 PIONEER CPAP SYSTEM (K041209) | Resmed, Ltd. | 2004-07-01 |
| MICROMESAM BASIC-SET (K040576) | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004-07-01 |
| IMASK TM (K041309) | Vital Signs, Inc. | 2004-06-30 |
| PORTABLE SLEEP DATA RECORDER (PSDR) (K033402) | Pro-Tech Services, Inc. | 2004-06-30 |
| GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM (K040862) | Caradyne, Ltd. | 2004-06-30 |
| TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 (K034053) | Tiara Medical Systems, Inc. | 2004-06-24 |
| ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 (K041412) | Respironics California, Inc. | 2004-06-18 |
| MODIFICATION TO NICO WITH MARS, MODEL 7300 (K041450) | Respironics Novametrix, Inc. | 2004-06-18 |
| MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR (K040847) | Draeger Medical, Inc. | 2004-06-17 |
| ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM (K041158) | Atrion Medical Products, Inc. | 2004-06-16 |
| BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 (K040657) | Vygon SA | 2004-06-10 |
| MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) (K040723) | Microlife Intellectual Property GmbH | 2004-06-10 |
| CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) (K040941) | Fisher & Paykel Healthcare, Ltd. | 2004-06-10 |
| AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER (K041418) | Cardinalhealth | 2004-06-10 |
| MEDICAL AIR COMPRESSOR (K040220) | eVent Medical, Ltd. | 2004-06-09 |
| HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND (K041035) | Hoffrichter GmbH | 2004-06-09 |
| MAXO2+, MODEL A AND AE (K040484) | Maxtec, Inc. | 2004-06-09 |
| VPAP III ST-A (K033276) | Resmed, Ltd. | 2004-06-07 |
| RESCONTROL II (K040944) | Resmed, Ltd. | 2004-06-03 |
| MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS (K040790) | Pulmonetic Systems, Inc. | 2004-06-03 |
| VENTLAB NASAL CPAP CANNULA (K040726) | Ventlab Corp. | 2004-06-03 |
| AIR SAFETY HEPA, MODEL 3500 (K040712) | Air Safety, Ltd. | 2004-06-03 |
| LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA (K040642) | Draeget Medical AG & Co. Kgaa | 2004-06-02 |
| TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 (K032170) | Medical Industries America, Inc. | 2004-05-28 |
| COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) (K040090) | Pneupac , Ltd. | 2004-05-27 |
| STARDUST II, MODEL 1011176 (K021845) | Respironics, Inc. | 2004-05-20 |
| INOGEN ONE OXYGEN CONCENTRATOR (K032818) | Inogen, Inc. | 2004-05-13 |
| POLARIS 2004 CAPNOGRAPH (K040011) | Oridion , Ltd. | 2004-05-13 |
| CLEAR-THERM MICRO HME, MODEL 1441 (K032322) | Intersurgical, Inc. | 2004-05-13 |
| AIR SAFETY HEPA AND NON-HEPA FILTERS (K033008) | Air Safety, Ltd. | 2004-05-13 |
| INOGEN SATELLITE CONSERVER (K033197) | Medical Electronic Devices, Inc. | 2004-05-13 |
| CHAD THERAPEUTICS SAGE (K033364) | Chad Therapeutics, Inc. | 2004-05-11 |
| OMNI~NEB; OMNI~MAX (K030396) | B&B Medical Technologies, Inc. | 2004-05-07 |
| STIMULONG PLUS CATHETER SET MODEL, VARIOUS (K033018) | Pajunk GmbH | 2004-05-05 |
| EFLOW ELECTRONIC INHALER/NEBULIZER (K033833) | Pari Innovative Manufacturers, Inc. | 2004-05-05 |
| FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A (K040506) | Fisher & Paykel Healthcare, Ltd. | 2004-05-05 |
| RESCAN (K034033) | Resmed, Ltd. | 2004-05-05 |
| REMSTAR AUTO WITH C-FLEX CPAP SYSTEM (K041010) | Respironics, Inc. | 2004-05-05 |
| DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR (K040069) | Dymedix, Inc. | 2004-05-05 |
| KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 (K033189) | King Systems Corp. | 2004-05-04 |
| MOBILE OXYGEN STORAGE TANK (MOST) (K040738) | Pacific Consolidated Industries Llp | 2004-04-30 |
| MODIFICATION TO LTV 1000 VENTILATOR (K040540) | Pulmonetic Systems, Inc. | 2004-04-29 |
| MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 (K040892) | Nidek Medical Products, Inc. | 2004-04-29 |
| PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B (K040917) | Philips Medizin Systeme Boeblingen GmbH | 2004-04-29 |
| NARKOMED 6400, MODEL NM6400 (K033498) | Draeger Medical, Inc. | 2004-04-26 |
| SERVO GUARD, MODEL 64 81 290 EH88E (K030071) | Maquet, Inc. | 2004-04-26 |
| DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 (K040605) | Dymedix, Inc. | 2004-04-26 |
| PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY (K020700) | Pegasus Research Corp. | 2004-04-26 |
| COMPUMEDICS SUMMIT IP (K040194) | Compumedics USA, Ltd. | 2004-04-23 |
| MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM (K040743) | Datex-Ohmeda, Inc. | 2004-04-22 |
| SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 (K032981) | Invamed Technologies, Inc. | 2004-04-22 |
| PRODOSE AAD SYSTEM (K030747) | Profile Therapeutics Plc | 2004-04-22 |
| OXYGEN DIVERTER VALVE (K033914) | Resmed, Ltd. | 2004-04-22 |
| INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE (K040188) | Draeger Medical Systems, Inc. | 2004-04-14 |
| KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (K033186) | King Systems Corp. | 2004-04-14 |
| MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU (K033710) | Fisher & Paykel Healthcare, Ltd. | 2004-04-13 |
| MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ (K040367) | Electromed, Inc. | 2004-04-07 |
| MASTERSCREEN CPX AND OXYCON CPX (K040698) | Viasys Healthcare GmbH | 2004-04-07 |
| LIFESTYLE CIRCULATORY ENHANCER (K040084) | Advanced Circulatory Systems, Inc. | 2004-04-07 |
| RESMED HOSPITAL NASAL MASK (K040566) | Resmed, Ltd. | 2004-04-02 |
| BIRDSONG LEVERHALER, MODEL LH-1000 (K031982) | Birdsong Medical Devices, Inc. | 2004-04-02 |
| TRUST (K040718) | Dhd Healthcare Corp. | 2004-04-02 |
| LIQUID OXYGEN SYSTEM (K032143) | Micro Technology Services, Inc. | 2004-03-30 |
| UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) (K032386) | Impact Instrumentation, Inc. | 2004-03-26 |
| INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 (K031176) | Invacare Corp. | 2004-03-25 |
| NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM (K033000) | Essex Cryogenics of Missouri, Inc. | 2004-03-22 |
| MARK 5 NUVO (M5C5) (K032509) | Nidek Medical Products, Inc. | 2004-03-18 |
| BIRD TBIRD VELA VENTILATOR (K032451) | Bird Products Corp. | 2004-03-17 |
| MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM (K030624) | Draeger Medical, Inc. | 2004-03-17 |
| PLV CONTINUUM VENTILATOR, MODEL P2000 (K034032) | Respironics California, Inc. | 2004-03-16 |
| RFS VACUUM GAUGE SCAVENGING CIRCUIT (K033503) | Accutron, Inc. | 2004-03-12 |
| INVACARE POLARIS EX CPAP, MODEL ISP3000 (K031064) | Invacare Corp. | 2004-03-12 |
| ENDOFLEX TRACHEAL TUBE (K031794) | Merlyn Associates, Inc. | 2004-03-12 |
| DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM (K032803) | Datex-Ohmeda | 2004-03-10 |
| POGS 33 (K030920) | On Site Gas Systems, Inc. | 2004-03-10 |
| PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER (K033080) | Portex, Inc. | 2004-03-10 |
| LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 (K033518) | Custom Plastic Products | 2004-03-10 |
| S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM (K030797) | Resmed Corp | 2004-03-10 |
| RESMED S8 PRIME CPAP SYSTEM (K033841) | Resmed, Ltd. | 2004-03-10 |
| BIPAP PRO 2 BI-LEVEL SYSTEM (K032834) | Respironics, Inc. | 2004-03-04 |
| HIOX80 AEROSOL ADAPTER (K032516) | Sensor Medics Corp. | 2004-03-04 |
| PRESSURE MANIFOLD, MODEL BC 110 (K040366) | Fisher & Paykel Healthcare, Ltd. | 2004-03-04 |
| TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H (K040507) | Taga Medical Technologies, Inc. | 2004-03-04 |
| TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 (K031935) | Tiara Medical Systems, Inc. | 2004-03-03 |