| BIPAP SYNCHRONY WITH AVAPS (K070328) | Respironics Inc., Sleep & Home Respiratory Group | 2007-05-08 |
| CHAD THERAPEUTICS BONSAI MODEL 800 (K070740) | Chad Therapeutics, Inc. | 2007-05-07 |
| AERONEB PROFESSIONAL NEBULIZER SYSTEM (K070642) | Aerogen (Ireland), Ltd. | 2007-05-07 |
| NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM (K070326) | Widemed, Ltd. | 2007-05-05 |
| APEX MEDICAL XT1 CPAP, MODEL 9S-005 (K070609) | Apex Medical Corp. | 2007-05-04 |
| AUTOVENT MODEL 4000 (K070120) | Allied Healthcare Products, Inc. | 2007-05-03 |
| MEDISIZE GOLD HEATER AND BOOSTER (K070714) | Medisize BV | 2007-04-30 |
| TWILIGHT FULL FACE MASK (K070321) | Invacare Corp. | 2007-04-30 |
| INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K070867) | Ino Therapeutics, LLC | 2007-04-27 |
| HYPER SAL (K070498) | Pari Innovative Manufacturers, Inc. | 2007-04-26 |
| ECHOSTIM FACET TIP (K063380) | Havel'S, Inc. | 2007-04-25 |
| HSINER NEBULIZER BOTTLE (K070948) | Hsiner | 2007-04-25 |
| CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R (K063758) | Teleflex Medical | 2007-04-23 |
| TALKING TRACH (K062104) | Engineered Medical Systems, Inc. | 2007-04-20 |
| GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM (K070210) | Ohmeda Medical | 2007-04-20 |
| GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (K070247) | Ohmeda Medical | 2007-04-20 |
| LINDE INTEGRATED VALVE (LIV) (K063354) | Linde Gas Therapeutics | 2007-04-17 |
| HEALTH MASK (K070467) | Polar Wrap, LLC | 2007-04-17 |
| EXPRESS SERIES (K070858) | Medical Graphics Corp. | 2007-04-16 |
| DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B (K063071) | Kyphon, Inc. | 2007-04-13 |
| VAPOTHERM MODEL# 2000I AND 2000H (K070056) | Vapotherm, Inc. | 2007-04-13 |
| FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) (K063125) | Arc Medical, Inc. | 2007-04-13 |
| AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR (K070674) | Trudell Medical Intl. | 2007-04-11 |
| KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US (K063501) | Mallinckrodt Developpement France | 2007-04-06 |
| FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB (K062014) | Flaem Nuova S.P.A. | 2007-03-22 |
| MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 (K070134) | Stockert GmbH | 2007-03-22 |
| FREQUENCER, MODEL 1001 (K063645) | Dymedso, Inc. | 2007-03-15 |
| SECURE ARTERIAL BLOOD SAMPLING SYSTEM (K070340) | Smiths Medical Asd, Inc. | 2007-03-15 |
| REMSTAR AFLEX CPAP SYSTEM (K063830) | Respironics Inc., Sleep & Home Respiratory Group | 2007-03-09 |
| DELUXE NEBULIZER (K063449) | Access Point Medical, LLC | 2007-03-01 |
| PRECISION OXYGEN MONITOR (K063096) | Precision Medical, Inc. | 2007-02-27 |
| PARI HYDRATE G (K070107) | Pari Innovative Manufacturers, Inc. | 2007-02-23 |
| OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 (K062263) | Omron Healthcare, Inc. | 2007-02-23 |
| CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 (K063268) | Hsiner Co., Ltd. | 2007-02-23 |
| BIPAP AUTOSV (K063540) | Respironics, Inc. | 2007-02-22 |
| ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM (K062388) | Docusys | 2007-02-22 |
| MAXO2 CU (K063488) | Maxtec, Inc. | 2007-02-22 |
| C300 SERIES AIR NEBULIZER COMPRESSOR (K062952) | Choice Smart Health Care Co. , Ltd. | 2007-02-21 |
| BIPAP SYNCHRONY (K063533) | Respironics, Inc. | 2007-02-20 |
| SIDESTREAM PLUS (K062689) | Respironics , Ltd. | 2007-02-16 |
| VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 (K063650) | Puritan Bennett Corp. | 2007-02-15 |
| CO2 EASY (K070128) | Westmed, Inc. | 2007-02-15 |
| SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 (K063404) | Maquet Critical Care AB | 2007-02-15 |
| NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET (K063477) | Novamed, LLC | 2007-02-09 |
| CLAVIS (K062478) | Medtronic A/S | 2007-02-08 |
| SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION (K062793) | Maquet Critical Care AB | 2007-02-07 |
| EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) (K063167) | Phasein AB | 2007-02-06 |
| MIRAGE QUATTRO FULL FACE MASK (K063122) | Resmed, Ltd. | 2007-02-02 |
| MIRAGE LIBERTY FULL FACE MASK (K063011) | Resmed, Ltd. | 2007-02-02 |
| ASTRA 300 (K061571) | Sdi Diagnostics, Inc. | 2007-01-31 |
| ASTRAGUARD PULMONARY FUNCTION FILTER (K062913) | Sdi Diagnostics, Inc. | 2007-01-26 |
| SOMNOSCREEN (K060708) | Somnomedics GmbH & Co. KG | 2007-01-24 |
| EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD (K061414) | Pacific Consolidated Industries, LLC | 2007-01-22 |
| GLASS LOSS OF RESISTANCE SYRINGE (K063018) | Busse Hospital Disposables, Inc. | 2007-01-22 |
| BREAS ISLEEP 20I (K063476) | Breas Medical AB | 2007-01-22 |
| PAJUNKS STIMULONG TSUI-METHOD SET (K062900) | PAJUNK GmbH Medizintechnologie | 2007-01-12 |
| AG-EDGE, MODEL 91200 (K063103) | Medel S.P.A. | 2007-01-08 |
| CARBON DIOXIDE MONITOR, MODEL OLG-2800A (K062115) | Nihon Kohden America, Inc. | 2006-12-27 |
| OPUS HC482 DIRECT NASAL MASK (K063036) | Fisher & Paykel Healthcare, Ltd. | 2006-12-22 |
| DPILOG, MODEL DPC-512 (K062811) | Life Outcomes, Inc. | 2006-12-20 |
| LOSS OF RESISTANCE SYRINGE (K061737) | Robert Busse & Co., Inc. | 2006-12-18 |
| PULMOLIFE (K061283) | Micro Medical, Ltd. | 2006-12-14 |
| INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K061901) | Ino Therapeutics | 2006-12-14 |
| MINISPIR; SPIROLAB III (K061875) | Mir Medical Intl. Research Srl | 2006-12-11 |
| GE DATEX-OHMEDA ENGSTROM CARESTATION (K062710) | Datex-Ohmeda, Inc. | 2006-12-08 |
| HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 (K062664) | Apex Medical Corp. | 2006-12-06 |
| SPIROBANK II (K061712) | Mir Medical Intl. Research Srl | 2006-12-01 |
| DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (K063519) | Anesthetic Gas Reclamation, LLC | 2006-12-01 |
| OX-SOX, MODEL C, D, E, (K062300) | Pattient Safety Innovations, Llp | 2006-11-27 |
| STIMUPLEX PEN (K061983) | Stockert GmbH | 2006-11-21 |
| ON-Q INTRODUCERS (K063234) | I-Flow Corp. | 2006-11-21 |
| CADWELL EASYNET NASAL PRESSURE MODULE (K061705) | Cadwell Laboratories, Inc. | 2006-11-21 |
| PORTABLE OXYGEN GENERATOR SYSTEM (K062153) | Molecular Products , Ltd. | 2006-11-21 |
| TRU-MR LARYNGOSCOPE SET (K062523) | Truphatek International, Ltd. | 2006-11-17 |
| DIGITAL MXR-D FLOWMETER (K062155) | Porter Instrument Co., Inc. | 2006-11-09 |
| SOYALA FULL FACE MASK (K061653) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2006-11-09 |
| GAS MODULE SE, MODEL 0998-00-0481-02 (K062754) | Datascope Corp. | 2006-11-02 |
| OXYLOG 3000 (K062267) | Drager Medical B.V. | 2006-10-31 |
| REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (K060265) | Remcore, Inc. | 2006-10-25 |
| PORTEX EPIDURAL CATHETER (K062005) | Smiths Medical Asd, Inc. | 2006-10-18 |
| RESUSCITATION TIMER, MODEL L770-CPR (K062080) | Allied Healthcare Products, Inc. | 2006-10-18 |
| PAJUNK MULTISTIM SENSOR NERVE STIMULATORS (K061172) | PAJUNK GmbH Medizintechnologie | 2006-10-17 |
| SANDMAN POCKET (K061996) | Eb Neuro S.P.A. | 2006-10-03 |
| MEDICAL COMPRESSOR, MODELS DK50 D AND DM (K060781) | Ekom S.R.O. | 2006-10-03 |
| CYTORI CELUTION CELL CONCENTRATION DEVICE (K060482) | Cytori Therapeutics, Inc. | 2006-09-28 |
| AVEA VENTILATOR (K062093) | Viasys Respiratory Care, Inc. | 2006-09-20 |
| VPAP MALIBU WITH H2I (K062291) | Resmed, Ltd. | 2006-09-08 |
| CYL-FIL OXYGEN SYSTEM (K061785) | Responsive Respiratory, Inc. | 2006-09-07 |
| SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) (K061394) | Busse Hospital Disposables, Inc. | 2006-09-06 |
| MEDGRAPHICS ULTIMA SYSTEM (K061731) | Medical Graphics Corp. | 2006-09-06 |
| MEDIBYTE, MODEL MP8 (K061764) | Braebon Medical Corp. | 2006-09-06 |
| LIFESOUND ESOPHAGEAL STETHOSCOPE (K062020) | Novamed, LLC | 2006-09-05 |
| INVACARE'S TWILIGHT II NASAL MASKS (K061874) | Invacare Corp. | 2006-09-05 |
| MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (K062230) | Minrad, Inc. | 2006-08-31 |
| MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (K062231) | Minrad, Inc. | 2006-08-31 |
| FLEXIFIT HC432 FULL FACE MASK (K061236) | Fisher & Paykel Healthcare, Ltd. | 2006-08-29 |
| LC SPRINT STAR (K062158) | Pari Innovative Manufacturers, Inc. | 2006-08-28 |
| COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA (K061736) | Teleflex Medical | 2006-08-18 |
| ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. (K060657) | Breas Medical AB | 2006-08-18 |
| RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD (K062019) | Innomed Technologies, Inc./Respcare, Inc. | 2006-08-17 |