| NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG (K023342) | Hdc Corp. | 2004-03-02 |
| BILEVEL CPAP, MODEL 9055 SERIES (K032056) | Sunrise Medical | 2004-02-20 |
| SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K040221) | Maquet Critical Care AB | 2004-02-20 |
| C2 NASAL MASK (K033759) | Respironics, Inc. | 2004-02-19 |
| PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY (K040014) | Portex , Ltd. | 2004-02-13 |
| INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION (K031745) | Sensor Medics Corp. | 2004-02-13 |
| MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 (K031741) | Alaris Medical Systems, Inc. | 2004-02-09 |
| BAWMED E-Z BAG RESUSCITATOR (K031434) | Bawmed UK | 2004-02-06 |
| APEX MEDICAL CPAP RT 21XX (K022650) | Apex Medical Corp. | 2004-02-04 |
| PERIFIX CATHETER CONNECTOR (K033952) | B.Braun Medical, Inc. | 2004-02-04 |
| MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (K032593) | Mercury Medical | 2004-02-03 |
| VADI MANUAL RESUSCITATOR (K030864) | Vedi Corp. | 2004-01-30 |
| FLOSENSE II, MODEL 29-8040 (K033939) | Sdi Diagnostics, Inc. | 2004-01-30 |
| MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM (K030418) | Makai Marine Industries, Inc. | 2004-01-29 |
| VIANOX DELIVERY SYSTEM, MODEL II (K033779) | Pulmonox Medical, Inc. | 2004-01-26 |
| P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) (K032112) | Portex , Ltd. | 2004-01-26 |
| NEWPORT E500 WAVE VENTILATOR (K030780) | Newport Medical Instruments, Inc. | 2004-01-23 |
| ESPRIT VENTILATOR, MODEL V1000 (K034040) | Respironics, Inc. | 2004-01-21 |
| AEROMIST LT, MODEL HCS15004 (K031686) | Medline Industries, Inc. | 2004-01-21 |
| SK MED ME202 MONITORING MIXER (K031860) | Sk Med | 2004-01-21 |
| MODIFICATION TO INSPIRATION VENTILATOR SYSTEM (K030341) | eVent Medical, Ltd. | 2004-01-16 |
| B-SMART, MODEL B-01 (K031128) | Macosta Medical USA, LLC | 2004-01-15 |
| AEROCHAMBER MAX VALVED HOLDING CHAMBER (K032972) | Trudell Medical Intl. | 2004-01-14 |
| ORACLE ORAL MASK, MODEL HC451A (K033087) | Fisher & Paykel Healthcare, Ltd. | 2004-01-14 |
| MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) (K031908) | Med2000 S.R.L. | 2004-01-14 |
| NASAL-AIR CRITICAL CARE (K031896) | Innomed Technologies | 2004-01-14 |
| BAY AREA HYPERSCIENCES (K030713) | Bay Area Hypersciences, LLC | 2003-12-19 |
| SPIROTEL, MODEL 29-1020 (K031643) | Sdi Diagnostics, Inc. | 2003-12-09 |
| SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES (K031649) | Fink Engineering Pty, Ltd. | 2003-12-05 |
| MIRAGE ACTIVA MASK (K032916) | Resmed, Ltd. | 2003-12-04 |
| MICROLAB SPIROMETER (K031102) | Micro Direct, Inc. | 2003-12-01 |
| MULTI-STRAP FULL FACE MASK (K023683) | Engineered Medical Systems | 2003-12-01 |
| PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) (K032716) | Portex , Ltd. | 2003-11-28 |
| MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (K031997) | Mallinckrodt Dar S.R.L. | 2003-11-25 |
| ELECTRO FLO PERCUSSOR, MODEL 5000 (K031876) | Med Systems | 2003-11-21 |
| AERONEB GO NEBULIZER, MODEL AG-AG2000 (K032849) | Aerogen, Inc. | 2003-11-21 |
| MODIFICATION TO RESQPOD CIRCULATORY ENHANCER (K033401) | Advanced Circulatory Systems, Inc. | 2003-11-20 |
| PLV CONTINUUM VENTILATOR, MODEL P1000 (K022750) | Respironics California, Inc. | 2003-11-20 |
| SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES (K031553) | Arcadia Medical Corporation | 2003-11-18 |
| MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 (K031024) | Microlife Corp. | 2003-11-14 |
| BARD ENDOTRACHEAL TUBE, CUFFED (K030792) | C.R. Bard, Inc. | 2003-11-14 |
| SHILEY FLEXTRA TRACHEOSTOMY TUBE (K030787) | Nellcor Puritan Bennett, Inc. | 2003-11-14 |
| HOSPITAL SPACER (K032809) | Respironics Healthscan, Inc. | 2003-11-13 |
| OXYCON MOBILE (K023120) | Erich Jaeger GmbH | 2003-11-12 |
| EMBLA N7000 (K024322) | Medcare Flaga | 2003-10-27 |
| SMARTMONITOR 2 PROFESSIONAL SERIES (PS) (K032403) | Respironics, Inc. | 2003-10-27 |
| NASAL JACKS MASK (K032433) | Resmed, Ltd. | 2003-10-24 |
| RAPHAEL (K022679) | Hamilton Medical AG | 2003-10-22 |
| AUTOSET SPIRIT SYSTEM (K032480) | Resmed, Ltd. | 2003-10-16 |
| LTV-1000 VENTILATOR (K032226) | Pulmonetic Systems, Inc. | 2003-10-16 |
| BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (K030985) | Vital Signs, Inc. | 2003-10-15 |
| NICO WITH MARS, MODEL 7300 (K030886) | Respironics Novametrix, Inc. | 2003-10-07 |
| VIGORMIST COMPRESSOR NEBULIZER (K031413) | Vega Technologies, Inc. | 2003-10-07 |
| DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS (K023366) | Datex-Ohmeda, Inc. | 2003-10-07 |
| ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER (K024023) | Essex Medical Systems Plus | 2003-10-01 |
| PERIFIX CATHETER CONNECTOR (K032144) | B.Braun Medical, Inc. | 2003-10-01 |
| PARAPAC 200D TRANSPORT, MODEL V200D (K030803) | Pneupac , Ltd. | 2003-09-29 |
| BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE (K030570) | Portex , Ltd. | 2003-09-17 |
| INOVO, INC, ECONOMIZER CONSERVING REGULATOR (K031983) | Inovo, Inc. | 2003-09-15 |
| PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 (K022752) | Hdc Corp. | 2003-09-09 |
| ARABELLA NCPAP MASKS (K030563) | Hamilton Medical AG | 2003-09-09 |
| COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E (K023354) | Siemens Elema AB | 2003-09-05 |
| MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM (K032390) | Ebi, L.P. | 2003-08-29 |
| APLAB, MODEL 801D0030 (K030379) | Sector Medical Corp. | 2003-08-29 |
| MICROPEAK (K030586) | Micro Direct, Inc. | 2003-08-27 |
| PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA (K030381) | Portex , Ltd. | 2003-08-27 |
| SONIK LDI 20 AIR (K030374) | Evit Labs, Inc. | 2003-08-25 |
| EASY PULSE II OXYGEN CONSERVER (K032018) | Precision Medical, Inc. | 2003-08-25 |
| LYRA NASAL MASK (K031883) | Sensor Medics Corp. | 2003-08-25 |
| ADVISOR, MODEL 9200 (K030407) | Bci, Inc. | 2003-08-19 |
| MIRAGE VISTA MASK (K031047) | Resmed, Ltd. | 2003-08-19 |
| VPAP III (K030843) | Resmed, Ltd. | 2003-08-15 |
| VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 (K023140) | Epimed International, Inc. | 2003-08-15 |
| STATCO2METER, MODEL 10-55372 (K031814) | Mercury Medical | 2003-08-14 |
| VIANOX DELIVERY SYSTEM, MODEL I (K023014) | Pulmonox Medical, Inc. | 2003-08-14 |
| IVENT 201 PORTABLE VENTILATOR (K021981) | Versamed , Ltd. | 2003-08-13 |
| SK MED M201 PLUS MIXER (K031707) | Sk Med | 2003-08-01 |
| MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 (K031411) | Mercury Medical | 2003-07-30 |
| SPIROSOFT (K031194) | Viasys Healthcare GmbH | 2003-07-30 |
| BIPAP HARMONY VENTILATORY SUPPORT SYSTEM (K031656) | Respironics, Inc. | 2003-07-30 |
| S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K031554) | Genzyme Biosurgery | 2003-07-25 |
| HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION (K014074) | Hoffrichter GmbH | 2003-07-23 |
| PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT (K031057) | Portex, Inc. | 2003-07-18 |
| TAGA VELOCITY HUMIDIFIER (K031179) | Taga Medical Technologies, Inc. | 2003-07-17 |
| RX300 OXYGEN ANALYZER (K024228) | Teledyne Analytical Instruments | 2003-07-17 |
| MX 300 OXYGEN MONITOR (K024155) | Teledyne Analytical Instruments | 2003-07-17 |
| COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER (K021841) | Pneupac , Ltd. | 2003-07-17 |
| PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE (K030939) | Philips Medical Systems | 2003-07-15 |
| FABIUS TIRO ANESTHESIA SYSTEM (K031400) | Draeger Medical, Inc. | 2003-07-15 |
| MODEL 780 (K031383) | Hudson Respiratory Care, Inc. | 2003-07-07 |
| VENTLAB BACTERIAL FILTER, MODEL BF100 (K030271) | Ventlab Corp. | 2003-07-07 |
| RESPIRATORY HUMIDIFIER, MODEL MR850 (K020332) | Fisher & Paykel Healthcare, Ltd. | 2003-07-07 |
| S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK (K024191) | Resmed, Ltd. | 2003-07-02 |
| SMART BAG MO (K021328) | O-Two Systems International, Inc. | 2003-06-26 |
| DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) (K031027) | Datex-Ohmeda, Inc. | 2003-06-26 |
| DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR (K030990) | Datex-Ohmeda | 2003-06-25 |
| MODIFICATION TO REMSTAR AUTO CPAP SYSTEM (K031460) | Respironics, Inc. | 2003-06-24 |
| CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 (K024270) | Intersurgical, Inc. | 2003-06-24 |
| DATEX-OHMEDA HMEF 750 (K031653) | Datex-Ohmeda | 2003-06-20 |
| SINGLE USE ORAL MASK, MODEL HC455A (K023670) | Fisher & Paykel Healthcare, Ltd. | 2003-06-12 |