| ENGSTROM CARESTATION, ENGSTROM PRO (K081842) | Datex-Ohmeda, Inc. | 2008-10-03 |
| SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES (K082520) | Mallinckrodt Medical | 2008-10-02 |
| PROLONG (K081864) | Life-Tech, Inc. | 2008-09-25 |
| MODIFICATION TO HAMILTON-G5 (K081521) | Hamilton Medical AG | 2008-09-25 |
| HYGEIA-5 OXYGEN CONCENTRATOR (K081267) | Kedl Internation Limited | 2008-09-23 |
| CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS (K081743) | Draeger Medical AG & Co. KG | 2008-09-22 |
| GOLOX-93 (K081779) | Respironics, Inc. | 2008-09-19 |
| SOMNOWATCH (K081485) | Somnomedics GmbH | 2008-09-18 |
| ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 (K081738) | Health & Life Co., Ltd. | 2008-09-17 |
| SLEEPSTYLE 200 AUTO SERIES HC254 (K081029) | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 |
| SAVE RESUSCITATOR (K073410) | Artivent Corporation | 2008-09-12 |
| BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES (K081440) | Smiths Medical Asd, Inc. | 2008-09-12 |
| NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS (K081778) | Instrumentation Industries, Inc. | 2008-09-12 |
| FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK (K080209) | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 |
| NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (K081693) | Instrumentation Industries, Inc. | 2008-09-11 |
| VEO MULTIGAS MONITOR FOR POCKET PC (K081601) | Phasein AB | 2008-09-04 |
| RMX PHYSIOLOGICAL DATA RECORDER (K080375) | S.L.P. , Ltd. | 2008-09-02 |
| GE DATEX-OHMEDA AVANCE (K081844) | Datex-Ohmeda, Inc. | 2008-08-29 |
| INOMAX DS (DELIVERY SYSTEM) (K081691) | Ino Therapeutics, LLC | 2008-08-28 |
| HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN (K081508) | Shenyang Canta Medical Tech. Co., Ltd. | 2008-08-27 |
| MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT (K081516) | Medsource International, LLC | 2008-08-26 |
| DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES (K081468) | Sunrise Medical | 2008-08-25 |
| HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS (K082009) | Hsiner Co., Ltd. | 2008-08-22 |
| GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM (K081388) | Pronia Medical System, LLC | 2008-08-21 |
| VIP PULMONARY FUNCTION SYSTEM (K080510) | Viasys Healthcare GmbH | 2008-08-20 |
| MASS CASUALTY VENTILATOR, MODEL MCV100 (K080063) | Allied Healthcare Products, Inc. | 2008-08-15 |
| WATCH-PAT 200S-2 (WP200S-2) (K081982) | Itamar Medical | 2008-08-14 |
| AVEA VENTILATOR (K081837) | Cardinal Health 207, Inc. | 2008-08-13 |
| PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 (K081086) | Smiths Medical Asd, Inc. | 2008-08-13 |
| AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER (K080926) | Trudell Medical Intl. | 2008-08-12 |
| EMBLETTA GOLD (K073682) | Embla Systems, Inc. | 2008-08-08 |
| PROVENT NASAL CANNULA (K080983) | Ventus Medical, Inc. | 2008-08-07 |
| NAVIGATOR APPLICATIONS SUITE (K081941) | GE Healthcare Finland Oy | 2008-08-07 |
| INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K080484) | Ino Therapeutics | 2008-08-06 |
| HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED (K080603) | Te ME NA Sas | 2008-08-05 |
| FABIUS MRI (K072884) | Draeger Medical AG & Co. KG | 2008-07-30 |
| HOMELOX (K081206) | Respironics, Inc. | 2008-07-28 |
| FLOCHANNEL (K081176) | Chad Therapeutics, Inc. | 2008-07-28 |
| HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS (K081506) | Hyperbaric America, LLC | 2008-07-25 |
| HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 (K080969) | Medi Nuclear Corp., Inc. | 2008-07-25 |
| SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR (K080922) | Salter Labs, Division of Regulatory Affairs | 2008-07-25 |
| BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 (K081446) | Becton, Dickinson & CO | 2008-07-17 |
| PRECISION FLOW (K072845) | Vapotherm, Inc. | 2008-07-17 |
| ULTRASONIC NEBULISER MODEL 2010 (K072136) | Wilfred Kromker GmbH | 2008-07-15 |
| WELL LEAD REINFORCED ENDOTRACHEAL TUBE (K073383) | Well Lead Medical Instruments | 2008-07-10 |
| HUMIDAIRE 2I (K080797) | Resmed, Ltd. | 2008-07-09 |
| BUSSE PLASTIC LOR SYRINGE (K080804) | Busse Hosipital Disposables | 2008-07-09 |
| WATCHHALER (K080100) | Activaero America, Inc. | 2008-06-30 |
| NEB-90 LARGE VOLUME MEDICATION NEBULIZER (K080657) | Medi Nuclear Corp., Inc. | 2008-06-30 |
| FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT (K080734) | Viasys Healthcare GmbH | 2008-06-26 |
| PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR (K073702) | Lazarus Medical, LLC | 2008-06-26 |
| MODIFICATION TO GALILEO GOLD (K080181) | Hamilton Medical AG | 2008-06-24 |
| LAMIN AIR (K080516) | Remgenic, LLC | 2008-06-23 |
| PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT (K080675) | PAJUNK GmbH Medizintechnologie | 2008-06-20 |
| MERCURY VCO2 MODULE WITH CAPNOSTAT 5 (K080652) | Respironics Novametrix, LLC | 2008-06-20 |
| MACS CPAP SYSTEM (K080692) | Airon Corporation | 2008-06-20 |
| MODIFICATION TO: SPIRIT (K080023) | Caire, Inc. | 2008-06-16 |
| SIGMA SERIES HYPERBARIC CHAMBER (K072427) | Perry Baromedical Corp. | 2008-06-11 |
| NEB-U-MASK SYSTEM, MODELS 1895, 1896 (K080230) | Teleflexmedical, Inc. | 2008-06-09 |
| NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 (K080175) | Datascope Corp., Patient Monitoring Division | 2008-06-09 |
| WATCH-PAT 200I (WP200I) (K081037) | Itamar Medical | 2008-06-09 |
| SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 (K073179) | Maquet Critical Care AB | 2008-06-09 |
| VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) (K073155) | Vitalograph (Ireland) , Ltd. | 2008-06-04 |
| PROVOX MICRON HME (K072582) | Atos Medical AB | 2008-05-30 |
| IVENT 2001 MRI CONDITIONAL (K073694) | Versamed Medical Systems, Inc. | 2008-05-30 |
| PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS (K072290) | Dima Italia Srl | 2008-05-29 |
| WATCH-PAT MODEL 100S-2 (K080427) | Itamar Medical | 2008-05-23 |
| SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM (K080321) | Snap Laboratories, LLC | 2008-05-23 |
| VAR MONITOR (K073261) | Vortran Medical Technology 1, Inc. | 2008-05-23 |
| SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE (K080439) | Mallinckrodt Developpement France | 2008-05-16 |
| CPAP MASK (K071915) | Arcimed Laboratories, LLC | 2008-05-14 |
| SOYALA GEL VENTED (K081014) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008-05-09 |
| PULMODYNE CHF FLOW GENERATOR SYSTEM (K080256) | Pulmodyne | 2008-05-09 |
| LAURIMED SPINAL INJECTION SYSTEM (K080140) | Laurimed, LLC | 2008-05-09 |
| COMFORTGEL FULL FACE MASK (K073600) | Respironics Inc., Sleep & Home Respiratory Group | 2008-04-25 |
| MEDDORNA WIRELESS PRN SPIROMETER 100 (K072722) | Meddorna, LLC | 2008-04-24 |
| MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE (K080821) | Kimberly-Clark Corp. | 2008-04-22 |
| PERIPHERAL NERVE BLOCK SUPPORT TRAY (K073187) | Life-Tech, Inc. | 2008-04-22 |
| MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (K072061) | Viasys Healthcare GmbH | 2008-04-22 |
| HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM (K073269) | Hypnocore, Ltd. | 2008-04-18 |
| OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS (K080082) | Oxlife, LLC | 2008-04-16 |
| PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (K080039) | G. Dundas Co.,Inc. | 2008-04-14 |
| COMPUMEDICS SOMTE PSG RECORDING SYSTEM (K072201) | Compumedics Limited | 2008-04-14 |
| MODIFICATION TO:SPECIALTY NEEDLES (K073222) | Busse Hospital Disposables, Inc. | 2008-04-09 |
| S8 ESCAPE II (K080079) | Resmed, Ltd. | 2008-04-08 |
| CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 (K072885) | Draeger Medical AG & Co. KG | 2008-04-07 |
| VPAP ST (K080131) | Resmed, Ltd. | 2008-04-01 |
| RESPIRATORY HUMIDIFIER, MODEL MR850 (K073706) | Fisher & Paykel Healthcare, Ltd. | 2008-03-31 |
| SOYALA FULL FACE MASK GEL VENTED (K073673) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008-03-28 |
| VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA (K063813) | Ventlab Corp. | 2008-03-26 |
| AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) (K080170) | C.R. Bard, Inc. | 2008-03-25 |
| COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX (K071694) | Daiken Medical Co, Ltd. | 2008-03-20 |
| RESPIRONICS GOLOX (K072723) | Respironics, Inc. | 2008-03-20 |
| SLEEP QUALITY (K070855) | Dynadx Corporation | 2008-03-20 |
| SWIFT LT (K073638) | Resmed, Ltd. | 2008-03-20 |
| STRYKER ANTIMIC CATHETER (K072702) | Stryker Instruments, Instruments Div. | 2008-03-19 |
| DRIVE SOLSTICE OXYGEN CONCENTRATOR (K080391) | Medical Depot | 2008-03-18 |
| HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 (K072163) | 3A Health Care S.R.L. | 2008-03-06 |
| PORTABLE VENTILATOR, MODEL EPV-100 (K072214) | Allied Healthcare Products, Inc. | 2008-03-06 |
| DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR (K073516) | Kyphon, Inc. | 2008-02-21 |