| EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR (K070259) | Bedfont Scientific, Ltd. | 2008-02-21 |
| BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 (K071702) | Breas Medical AB | 2008-02-15 |
| AG-CLASSIC (K072494) | Medel S.P.A. | 2008-02-12 |
| DIVE AND SHALLOW AND GRAND DIVE (K072757) | Summit TO Sea | 2008-02-08 |
| REUSABLE HEADREST WITH NASAL SEAL (K072993) | Aeiomed, Inc. | 2008-02-08 |
| RK EPIDURAL NEEDLE (K072005) | Epimed International | 2008-02-07 |
| OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 (K072412) | Drager Medical AG & Co. Kgaa | 2008-02-06 |
| DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE (K063350) | PAJUNK GmbH Medizintechnologie | 2008-02-01 |
| HRI 6500, 6600 AND 6700 SERIES V2MASKS (K071149) | Hans Rudolph, Inc. | 2008-02-01 |
| FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 (K072002) | Draeger Medical AG & Co. KG | 2008-01-31 |
| RESUSCITATION TIMER, MODEL L770-CPR (K073171) | Allied Healthcare Products, Inc. | 2008-01-31 |
| GE DATEX-OHMEDA AISYS (K073707) | Datex-Ohmeda, Inc. | 2008-01-30 |
| MODIFICATION TO AVEA VENTILATOR (K073069) | Viasys Respiratory Care, Inc. | 2008-01-25 |
| MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE (K072420) | Oceanic Medical Products, Inc. | 2008-01-22 |
| LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 (K072688) | International Biophysics Corp. | 2008-01-11 |
| A&J POCA01 OXYGEN CONCENTRATOR (K071608) | Zhongshan A&J Medical Equipment Co., Ltd. | 2008-01-11 |
| NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS (K072292) | Dima Italia Srl | 2008-01-07 |
| INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM (K072590) | Event Medical, Inc. | 2008-01-04 |
| TXCONTROL (K072615) | Resmed, Ltd. | 2008-01-04 |
| DIGIFLO CONCENTRATOR ANALYZER (K072469) | Digiflo, Inc. | 2008-01-03 |
| PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 (K073242) | Delphi Medical Systems | 2008-01-03 |
| EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) (K072813) | Phasein AB | 2007-12-28 |
| AEROSOL SYSTEM (K063716) | Amici, Inc. | 2007-12-28 |
| REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM (K072996) | Respironics, Inc. | 2007-12-27 |
| SPIROBANK G (K072979) | Mir Medical Intl. Research Srl | 2007-12-26 |
| PERFORMAX TOTAL FACE MASK (K072592) | Respironics Inc., Sleep & Home Respiratory Group | 2007-12-19 |
| PERFORMAX SE TOTAL FACE MASK (K072588) | Respironics Inc., Sleep & Home Respiratory Group | 2007-12-18 |
| WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 (K072009) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007-12-14 |
| ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (K072621) | Cincinnati Sub-Zero Products, Inc. | 2007-12-13 |
| MIRAGE MICRO (K072940) | Resmed, Ltd. | 2007-12-13 |
| MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER (K072670) | Pari Innovative Manufacturers, Inc. | 2007-12-13 |
| PURITAN BENNETT LEGENDAIR XL2 (K070899) | Nellcor Puritan Bennett | 2007-12-13 |
| THE INVACARE FLYER, MODEL IPC 100 (K071928) | Invacare Corp. | 2007-12-12 |
| ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 (K072450) | Respironics California, Inc. | 2007-12-12 |
| YG-125T AND YG-135T NASAL ADAPTER (K072843) | Nihon Kohden America, Inc. | 2007-11-29 |
| PARI HYDRATE V (K072982) | Pari Innovative Manufacturers, Inc. | 2007-11-29 |
| FUNHALER, MODEL V-201E (K072822) | Infamed , Ltd. | 2007-11-26 |
| HAMILTON-G5 (K070513) | Hamilton Medical AG | 2007-11-26 |
| THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS (K071958) | Smiths Medical Asd, Inc. | 2007-11-21 |
| GALEMED CPAP MASK (K072755) | Galemed Corp. | 2007-11-16 |
| XPOD/XMAP NERVE STIMULATOR (K072092) | Xavant Technology (Pty), Ltd. | 2007-11-15 |
| EARLYSENSE ES-16 SYSTEM (K070375) | Earlysense, Ltd. | 2007-11-15 |
| VITASCORE (K072014) | Vitascore B.V. | 2007-11-08 |
| ISCALERT SENSOR SYSTEM (K071165) | Alertis Medical AS | 2007-11-07 |
| AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (K071365) | C.R. Bard, Inc. | 2007-11-06 |
| AKITA2 APIXNEB (K072019) | Activaero America, Inc. | 2007-11-05 |
| WIM-PC, MODEL 1010 (K071955) | Karmelsonix | 2007-11-01 |
| DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) (K071904) | Carleton Life Support Systems, Inc. | 2007-10-25 |
| PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS (K072050) | Life-Tech, Inc. | 2007-10-18 |
| COPD LIQUID OXYGEN PORTABLE, MODEL 300P (K072011) | Copd Partners, Inc. | 2007-10-18 |
| MINRAD INC. NASAL SCAVENGING CIRCUIT (K072255) | Minrad, Inc. | 2007-10-18 |
| RAPHAEL COLOR ASV VENTILATOR (K071194) | Hamilton Medical AG | 2007-10-18 |
| CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR (K071713) | Medical Decisions Network | 2007-10-12 |
| NAVIGATOR APPLICATIONS SUITE (K071097) | GE Healthcare Finland Oy | 2007-10-10 |
| MIRAGE MICRO (K071808) | Resmed, Ltd. | 2007-10-10 |
| MASTERSCREEN & OXYCON CPX (K072323) | Viasys Healthcare GmbH | 2007-10-10 |
| IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT) (K070354) | International Medical Development, Inc. | 2007-10-05 |
| PNEUPAC VR1 AIR MIX (K071527) | Smiths Medical International , Ltd. | 2007-10-04 |
| INOMAX DS (K071516) | Ino Therapeutics, LLC | 2007-10-03 |
| CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER (K072148) | Cook, Inc. | 2007-10-03 |
| APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 (K071230) | Advanced Brain Monitoring, Inc. | 2007-10-03 |
| DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES (K071397) | Sunrise Medical | 2007-10-01 |
| AMSURE NEBULIZER (K070411) | Amsino International, Inc. | 2007-10-01 |
| FITMATE SERIES (K071533) | Cosmed Srl | 2007-09-28 |
| OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER (K072418) | Respironics New Jersey, Inc. | 2007-09-12 |
| CPAP NASAL MASK WITH PILLOWS (K071773) | Lifesource | 2007-09-12 |
| NEOPIP INFANT RESUSCITATOR (K072021) | Neoforce Group, Inc. | 2007-09-12 |
| SANDMAN INTRO (K071575) | Mallinckrodt Developpement France | 2007-09-10 |
| DEVILBISS INTELLIPAP MODEL DV 5 SERIES (K071689) | Sunrise Medical | 2007-09-07 |
| SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 (K071221) | Automedx, Inc. | 2007-09-06 |
| PEDI CO2 EASY (K072220) | Westmed, Inc. | 2007-08-23 |
| MODEL 300D HOME OXYGEN LIQUEFIER (K071461) | Copd Partners, Inc. | 2007-08-21 |
| MASTERSCREEN PNEUMO & MASTERSCOPE (K071753) | Viasys Healthcare GmbH | 2007-08-14 |
| AIRLIFE NEBULIZER CAP (K072119) | Cardinalhealth | 2007-08-10 |
| BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM (K071509) | Respironics Inc., Sleep & Home Respiratory Group | 2007-08-08 |
| PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 (K070594) | Pulmonetic Systems, Inc. | 2007-08-01 |
| HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (K071269) | Smiths Medical Asd, Inc. | 2007-08-01 |
| ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 (K071212) | Respironics California, Inc. | 2007-07-30 |
| BUSSE EPIDURAL CATHETER (K070465) | Busse Hospital Disposables, Inc. | 2007-07-19 |
| WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 (K071163) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007-07-18 |
| SOMNOSCREEN EEG10-20 (K071556) | Somnomedics GmbH | 2007-07-18 |
| RESTRAXX DATA CENTRE, MODEL R10 (K070746) | Resmed, Ltd. | 2007-07-13 |
| AUTOVENT 4000 WITH CPAP (K070636) | Allied Healthcare Products, Inc. | 2007-07-13 |
| BACKPACK MEDICAL OXYGEN SYSTEM (K071581) | Essex Cryogenics of Missouri, Inc. | 2007-07-11 |
| VPAP AUTO WITH H3I (K071171) | Resmed, Ltd. | 2007-07-10 |
| A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER (K063526) | A-M Systems, Inc. | 2007-06-29 |
| TOPICAL APPLICATOR (K070596) | Sharn, Inc. | 2007-06-21 |
| CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET (K063282) | B.Braun Medical, Inc. | 2007-06-20 |
| CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) (K070490) | Advanced Circulatory Systems, Inc. | 2007-06-20 |
| APNEALINK (K070263) | Resmed Germany, Inc. | 2007-06-15 |
| GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR (K062883) | Gereonics, Inc. | 2007-06-13 |
| MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY (K071069) | Viasys Sleep Systems, LLC | 2007-06-12 |
| FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS (K062484) | Flaem Nuova S.P.A. | 2007-06-08 |
| PAJUNKS EPILONG SET PEDIATRIC (K062902) | PAJUNK GmbH Medizintechnologie | 2007-06-07 |
| GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM (K071142) | Datex-Ohmeda | 2007-06-06 |
| NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP (K070416) | Neoforce Group, Inc. | 2007-05-29 |
| APEX MEDICAL MOBINEB, 9R-027 SERIES (K070990) | Apex Medical Corp. | 2007-05-18 |
| SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED (K063806) | Sleepnet Corporation | 2007-05-17 |
| MODIFICATION TO FLOWSCREEN (K062011) | Viasys Healthcare GmbH | 2007-05-11 |
| POGS, MODEL 33C (K063454) | On Site Gas Systems, Inc. | 2007-05-09 |