| PLIX (K050414) | Respironics, Inc. | 2005-04-11 |
| ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE (K043529) | Roche Diagnostics Corp. | 2005-04-08 |
| FLEXIBLE SPINAL NEEDLE (K043467) | Epimed International, Inc. | 2005-03-31 |
| GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM (K050626) | Datex-Ohmeda, Inc. | 2005-03-25 |
| PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 (K050309) | Viasys Medsystems | 2005-03-25 |
| GE DATEX-OHMEDA ENGSTROM CARESTATION (K050597) | Datex-Ohmeda, Inc. | 2005-03-25 |
| ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN (K042058) | Clement Clarke Intl., Ltd. | 2005-03-23 |
| POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A (K042727) | Foremount Ent. Co., Ltd. | 2005-03-18 |
| TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) (K041311) | Tiger Medical Products, Ltd. | 2005-03-18 |
| ULTRA MIRAGE II MASK (K050359) | Resmed, Ltd. | 2005-03-16 |
| VENTILAIR II MEDICAL AIR COMPRESSOR (K041781) | Hamilton Medical AG | 2005-03-14 |
| SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, (K042556) | Enter Medical Corporation | 2005-03-11 |
| AURA CPAP SYSTEM (K042945) | Aeiomed, Inc. | 2005-03-09 |
| TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 (K043357) | Linde Medical Sensors AG | 2005-03-04 |
| SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM (K040202) | Salter Labs | 2005-03-04 |
| MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER (K043120) | Datex-Ohmeda, Inc. | 2005-03-01 |
| TCM40 MONITORING SYSTEM (K043003) | Radiometer Medical Aps | 2005-03-01 |
| C-CO2 COLORIMETRIC CO2 INDICATOR (K050066) | Marquest Medical Products, Inc. | 2005-03-01 |
| RESMED MERIDIAN MASK (K050142) | Resmed, Ltd. | 2005-03-01 |
| WELL LEAD ENDOTRACHEAL TUBE (K042683) | Well Lead Medical Instruments | 2005-02-18 |
| TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO (K043160) | Tracoe Medical GmbH | 2005-02-18 |
| AQUINOX (K050314) | Smiths Medical Asd, Inc. | 2005-02-18 |
| WELL LEAD TRACHEOSTOMY TUBE (K042684) | Well Lead Medical Instruments | 2005-02-17 |
| APEX MEDICAL MININEB & MINIPLUS (K050104) | Apex Medical Corp. | 2005-02-16 |
| MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 (K043006) | Respironics, Inc. | 2005-02-11 |
| DEVILBISS AUTOADJUST, MODEL 9054 SERIES (K043282) | Sunrise Medical | 2005-02-11 |
| OXYTEC, MODEL 900 (K043615) | Oxytec Medical Corporation | 2005-02-09 |
| GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM (K050055) | Datex-Ohmeda, Inc. | 2005-02-04 |
| BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX (K043607) | Respironics, Inc. | 2005-01-28 |
| TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 (K043382) | Tiara Medical Systems, Inc. | 2005-01-19 |
| LIFESCREEN APNEA (K042745) | Del Mar Reynolds Medical, Inc. | 2005-01-19 |
| DEVILBISS NASAL CPAP MASK, 9354 SERIES (K042455) | Sunrise Medical | 2005-01-14 |
| RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS (K034026) | Fisher & Paykel Healthcare, Ltd. | 2005-01-12 |
| MODIFICATION TO SOAKER CATHETER (K043456) | I-Flow Corp. | 2005-01-11 |
| GOODKNIGHT H20, MODEL M-114600-00 (K042184) | Mallinckrodt Developpement France | 2005-01-10 |
| RUSCH EASY TUBE (K043205) | Teleflex Medical | 2005-01-07 |
| PLASIATEK ACTUATOR (K041917) | Plasiatek, LLC | 2005-01-07 |
| INVACARE PRO, COMPACT AND PORTABLE DESKTOP (K042483) | Invacare Corporation | 2005-01-06 |
| HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (K043127) | Haemonetics Corp. | 2005-01-04 |
| FUNHALER, MODEL FH 101 (K042546) | Infamed , Ltd. | 2005-01-03 |
| WATCH PAT 100S (K042916) | Itamar Medical | 2004-12-29 |
| UNIVERSAL XACTTRACE (K043132) | Medcare Flaga | 2004-12-21 |
| MODIFICATION TO: PLEXALONG SETS (K042979) | Pajunk GmbH | 2004-12-21 |
| MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS (K043130) | Pajunk GmbH | 2004-12-21 |
| MODIFICATION TO: PNEUTON VENTILATOR (K043085) | Airon Corporation | 2004-12-20 |
| NEWPORT C250 AIR COMPRESSOR MODEL C250 (K041406) | Newport Medical Instruments | 2004-12-15 |
| ALL FLOW PULMONARY FUNCTION FILTER (K043148) | Alliance Tech Medical, Inc. | 2004-12-13 |
| EXPRESS AND OASIS CHEST DRAIN (K043140) | Atrium Medical Corp. | 2004-12-08 |
| PRIMUS US (K042607) | Draeger Medical, Inc. | 2004-11-26 |
| SMART BITEBLOC (K042665) | Oridion Medical 1987 , Ltd. | 2004-11-23 |
| CAPNOSTAT 5 (K042601) | Respironics Novametrix, Inc. | 2004-11-19 |
| IVENT 201 PORTABLE VENTILATOR (K042468) | Versamed Medical Systems, Inc. | 2004-11-17 |
| AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR (K042682) | Ambu, Inc. | 2004-11-15 |
| MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (K041852) | Minrad, Inc. | 2004-11-15 |
| MILLENIUM, MODELS 2000, 2001 AND 2002 (K041007) | Hyperbaric For Life, LLC | 2004-11-15 |
| AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS (K042843) | Ambu, Inc. | 2004-11-12 |
| GALILEO GOLD (K040574) | Hamilton Medical, Inc. | 2004-10-27 |
| GE DATEX-OHMEDA ENGSTROM CARESTATION (K041775) | Datex-Ohmeda, Inc. | 2004-10-26 |
| AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI (K041963) | American Bantex Corp. | 2004-10-20 |
| CAP-ONE, MODEL TG-920P (K040875) | Nihon Kohden America, Inc. | 2004-10-15 |
| APNEA RISK EVALUATION SYSTEM (ARES) (K041662) | Advanced Brain Monitoring, Inc. | 2004-10-14 |
| HEMOVAC BLOOD REINFUSION SYSTEM (K041525) | Zimmer, Inc. | 2004-10-14 |
| INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 (K042655) | Respironics New Jersey, Inc. | 2004-10-13 |
| FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (K042419) | Draeger Medical, Inc. | 2004-10-08 |
| MIRAGE SWIFT (K042403) | Resmed, Ltd. | 2004-10-08 |
| BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 (K041430) | Blease Medical Equipment , Ltd. | 2004-10-07 |
| SLEEPSENSE SLEEP SENSORS (K042253) | S.L.P. , Ltd. | 2004-10-06 |
| PRECISION LIQUID OXYGEN SYSTEM (K041122) | Precision Medical, Inc. | 2004-10-04 |
| PERIFIX CATHETER AND CONTIPLEX CATHETER (K042488) | B.Braun Medical, Inc. | 2004-09-30 |
| COMPASS M10 SYSTEM (K041724) | Medcare Flaga | 2004-09-28 |
| GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 (K041079) | Guan Hong Enterprise Co., Ltd. | 2004-09-28 |
| COSMED PONY FX (K040549) | Cosmed Srl | 2004-09-28 |
| D-VAPOR (K042276) | Draeger Medical, Inc. | 2004-09-23 |
| CLARISSA INFANT NCPAP CANNULA (K032922) | Airways Ltd., Inc. | 2004-09-22 |
| CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S (K042142) | Chad Therapeutics, Inc. | 2004-09-20 |
| KUNG SHIN, HMEF SK203 (K032878) | Kung Shin Plastics Co., Ltd. | 2004-09-20 |
| GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM (K041524) | Datex-Ohmeda, Inc. | 2004-09-20 |
| INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 (K042262) | Sequal Technologies, Inc. | 2004-09-10 |
| SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007) (K042294) | Suiter Enterprises, Inc. | 2004-09-10 |
| AURA CPAP PATIENT INTERFACE (K042130) | Aeiomed, Inc. | 2004-09-08 |
| PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES (K040965) | Pajunk GmbH | 2004-09-07 |
| COMPASS F10 SYSTEM (K041904) | Medcare Flaga | 2004-09-07 |
| NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER (K041082) | Newport Medical Instruments, Inc. | 2004-09-07 |
| MALLARD MODEL 3000 ANESTHESIA MACHINE (K033026) | Mallard Medical, Inc. | 2004-09-03 |
| SHINMED MODE SW-988 UNTRASONIC NEBULIZER (K031370) | Shining World Health Care Co., Ltd. | 2004-09-01 |
| INFINITY TRIDENT NMT POD (K042003) | Draeger Medical Systems, Inc. | 2004-09-01 |
| FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (K042086) | Draeger Medical, Inc. | 2004-08-31 |
| HC604 CPAP HUMIDIFIER (K041900) | Fisher & Paykel Healthcare, Ltd. | 2004-08-31 |
| GE DATEX-OHMEDA AISYS CARESTATION (K042154) | Datex-Ohmeda, Inc. | 2004-08-31 |
| VAPOTHERM MODEL#2000I, 200H (K042245) | Vapotherm, Inc. | 2004-08-30 |
| MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (K041974) | Med2000 S.R.L. | 2004-08-24 |
| PENCIL POINT NEEDLE (K041843) | Epimed International, Inc. | 2004-08-24 |
| FLO-RITE (K041057) | Ameriflo Corp. | 2004-08-12 |
| EMG - ESSENTIAL GAS MODULE, MODEL M1013A (K041956) | Draeget Medical AG & Co. Kgaa | 2004-08-09 |
| DELTA T (K041076) | Penlon , Ltd. | 2004-08-09 |
| SENTEC DIGITAL MONITOR MODEL #SDM (K041548) | Sentec, Inc. | 2004-08-09 |
| STURDY MANUAL RESUSCITATOR (K032596) | Sturdy Industrial Co., Ltd. | 2004-08-05 |
| MARPAC MESSENGER MODEL #501 (K041485) | Marpac, Inc. | 2004-08-02 |
| APEX MEDICAL CPAP MODEL 9S-003 (K041828) | Apex Medical Corp. | 2004-07-30 |
| MERLIN E-MASK (K031397) | Merlin Medical Limited | 2004-07-29 |