| HAMILTON-C1 (K120574) | Hamilton Medical AG | 2012-05-30 |
| VPAP TX (K113714) | Resmed, Ltd. | 2012-05-25 |
| SPIRTIUS CUFF INFLATION SYRINGE (K112915) | Spiritus Technologies, LLC | 2012-05-25 |
| VPAP ADAPT (K113801) | Resmed Corp | 2012-05-25 |
| PRIMED TRACHEOSTOMY TUBES (MULTIPLE) (K120079) | Primed Halberstadt Medizintechnik GmbH | 2012-05-24 |
| VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (K120118) | Ventlab Corp. | 2012-05-24 |
| CELL SAVER ELITE (K120586) | Haemonetics Corp. | 2012-05-22 |
| DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM (K113576) | Etview , Ltd. | 2012-05-18 |
| FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER (K103658) | Teleflex, Inc. | 2012-05-16 |
| APEX MEDICAL ICH CPAP SERIES (9S-007XXX) (K120035) | Apex Medical Corp. | 2012-05-16 |
| GENOSYL MV-1000 (K120216) | Geno, LLC | 2012-05-16 |
| KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS (K113333) | Kimberly-Clark Corporation | 2012-05-11 |
| SENTRYSUITE PRODUCT LINE (K113813) | Carefusion Germany 234 GmbH | 2012-05-10 |
| G+ SYSTEM (K113853) | Glytec, LLC | 2012-05-08 |
| END TIDAL CO2 NASAL CANNULA (K120518) | Care Fusion | 2012-05-04 |
| CAIRE COMPANION 5 OXYGEN CONCENTRATOR (K121167) | Caire, Inc. | 2012-05-02 |
| EQUINOX RELIEVE (K113687) | O-Two Medical Technologies, Inc. | 2012-04-30 |
| RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER (K110629) | 3B Products, Inc. | 2012-04-27 |
| AERONEB PRO (K120939) | Aerogen, Ltd. | 2012-04-26 |
| SLEEPWEAVER ELAN NASAL CPAP MASK (K120757) | Circadiance, LLC | 2012-04-24 |
| MCKESSON ANESTHESIA CARE (K113633) | Mckesson Technologies, Inc. | 2012-04-20 |
| EASYCARE TX SYSTEM (CONNEXUNS) (K113780) | Resmed, Ltd. | 2012-04-20 |
| FENESTRATED NERVE BLOCK NEEDLE (K113662) | Imd, Inc. | 2012-04-20 |
| SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML (K120051) | Nephron Pharmaceuticals Corp. | 2012-04-20 |
| ORBIT (K120880) | National Biomedical, LLC Dba Qrs Diagnostic | 2012-04-19 |
| DUAL HEATED INFANT VREATHING CIROUITS (K103767) | Fisher & Paykel Healthcare, Ltd. | 2012-04-16 |
| MICRO I (K113096) | Carefusion Germany 234 GmbH | 2012-04-13 |
| ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR (K111050) | Starboard Medical, LLC | 2012-04-12 |
| STELLAR 150 (K113640) | Resmed Germany, Inc. | 2012-04-05 |
| HAMILTON-T1 (K120670) | Hamilton Medical AG | 2012-04-03 |
| SIMPLE T NASAL MASK (K120145) | Respironics, Inc. | 2012-03-30 |
| RESPIRATORY HUMIDIFER (K110019) | Fisher & Paykel Healthcare, Ltd. | 2012-03-30 |
| VPAP ST-A (K113288) | Resmed, Ltd. | 2012-03-29 |
| SMARTPILOT VIEW MODEL MK04500 (K103035) | Draeger Medical GmbH | 2012-03-28 |
| RESSCAN (K113815) | Resmed, Ltd. | 2012-03-27 |
| SPACELABS ARKON ANESTHESIA WORKSTATION (K113051) | Spacelabs Healthcare | 2012-03-22 |
| COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 (K111933) | Covidien | 2012-03-15 |
| SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG (K113188) | PAJUNK GmbH Medizintechnologie | 2012-03-01 |
| MAXMIXING BLOCK (K113232) | Maxtec, Inc. | 2012-03-01 |
| SONO TAP, TUOHY SONO (K113207) | Pajunk GmbH | 2012-02-29 |
| INOMAX DS(DELIVERY SYSTEMS (K113272) | Ino Therapeutics, LLC/Dba Ikaria | 2012-02-29 |
| PILAIRO NASAL PILLOWS MASK (K120027) | Fisher & Paykel Healthcare Limited | 2012-02-23 |
| 3B WILLOW (K112271) | 3B Products, LLC | 2012-02-16 |
| UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR (K111473) | Impact Instrumentation, Inc. | 2012-02-16 |
| SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) (K113542) | Salter Labs, Arvin Facility | 2012-02-10 |
| HAMILTON-TC1 (K112006) | Hamilton Medical AG | 2012-02-09 |
| BIPAP A 30 VENTILATORY SUPPORT SYSTEM (K113053) | Respironics, Inc. | 2012-02-01 |
| NEUMOVENT GRAPHNET (K111595) | Tecme S.A. | 2012-01-27 |
| PILOT TUBE REPAIR KIT (K113644) | Instrumentation Industries, Inc. | 2012-01-26 |
| AM-6000 ANESTHESIA MACHINE (K120075) | Advanced Instrumentations, Inc. | 2012-01-26 |
| CONTIPLEX FX (K113059) | B.Braun Medical, Inc. | 2012-01-24 |
| V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE (K110083) | Respironics California, Inc. | 2012-01-13 |
| BABI PLUS NEONATAL RESUSCITATION BAG (K112852) | A Plus Medical | 2012-01-13 |
| MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 (K112114) | Maquet Critical Care AB | 2012-01-13 |
| APNEA RISK EVALUATION SYSTEM (ARES) (K112514) | Advanced Brain Monitoring, Inc. | 2012-01-09 |
| MIRAGE QUATTRO (K113127) | Resmed, Ltd. | 2012-01-06 |
| MYOGUIDE SYSTEM MODEL 8008 (K111985) | Intronix Technologies Corp. | 2011-12-30 |
| VPAP TX (K112914) | Resmed, Ltd. | 2011-12-29 |
| LIFECHOICE OXYGEN CONCENTRATOR (K113317) | Inova Labs, Inc. | 2011-12-28 |
| SLEEPSTRIP II (K112822) | S.L.P. , Ltd. | 2011-12-27 |
| O_TWO CPAP SYSTEM (K112546) | O-Two Medical Technologies, Inc. | 2011-12-27 |
| KOO SMALL VOLUME NEBULIZER (SVN) (K112041) | Koo (Shanghai) Industries Co., Ltd. | 2011-12-22 |
| MANUJET III (K112783) | VBM Medizintechnik GmbH | 2011-12-22 |
| PENCAN SPINAL NEEDLE (K112515) | B.Braun Medical, Inc. | 2011-12-22 |
| MICHELE SLEEP SCORING SYSTEMS (K112102) | Younes Sleep Technologies | 2011-12-20 |
| GE DATEX-OHMEDA AVANCE (K112722) | Datex-Ohmeda, Inc. | 2011-12-16 |
| REMSTAR AUTO A-FLEX HT (K113068) | Respironics, Inc. | 2011-12-16 |
| BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER (K112562) | Kimberly-Clark | 2011-12-15 |
| ULTRAMAXO2 OXYGEN ANALYER (K112402) | Maxtec, LLC | 2011-12-14 |
| CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION (K113111) | Inovo, Inc. | 2011-12-08 |
| SWIFT FX BELLA (K112489) | Resmed, Ltd. | 2011-12-07 |
| GENUINE FIRST AID CPR MASK (K112126) | Genuine First Aid, LLC | 2011-12-01 |
| NEWPORT HT70 VENTILATOR (K111146) | Newport Medical Instruments, Inc. | 2011-12-01 |
| HAMILTON-G5 (K103803) | Hamilton Medical AG | 2011-11-23 |
| QUIXIE NEBULIZER (K112564) | Odyssey Medical Technologies | 2011-11-23 |
| DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL (K112220) | Devilbiss Healthcare, LLC | 2011-11-22 |
| SPIRODOC (K103530) | Medical International Research USA, Inc. | 2011-11-21 |
| AMBU ASCOPE 2 (K110962) | Ambu A/S | 2011-11-18 |
| TASMAN (K112393) | Resmed, Ltd. | 2011-11-16 |
| SOYALA SILKGEL FULL FACE MASK (K112167) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-11-16 |
| CHARTIS CONSOLE (K111764) | Pulmonx, Inc. | 2011-11-10 |
| SPIRO PD (K103575) | Pmd Healthcare | 2011-11-09 |
| SIMPLYGO PORTABLE OXYGEN CONCENTRATOR (K111885) | Respironics, Inc. | 2011-11-04 |
| MEDISIZE RED AND MEDISIZE BLUE (K110246) | Qserve America, Inc. | 2011-11-04 |
| LCI OPTION FOR INNOCOR (K102047) | Innovision A/S | 2011-11-01 |
| FLIGHT 60 VENTILATOR (K111683) | Flight Medical Innovations , Ltd. | 2011-10-31 |
| GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS (K110594) | Nihon Kohden Corp. | 2011-10-28 |
| I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM (K102454) | Respironics Respiratory Drug Delivery (Uk) , Ltd. | 2011-10-25 |
| SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 (K101286) | Linde Healthcare AB | 2011-10-20 |
| ALERKAN SPIROMETRY FILTER (K111587) | Alerkan, Ltd. | 2011-10-20 |
| MICROGARD II (K111408) | Carefusion Germany 234 GmbH | 2011-10-17 |
| TRILOGY SERIES VENTILATOR WITH OXIMETRY (K111610) | Respironics, Inc. | 2011-10-14 |
| 3B FLEX-LITE (K103434) | 3B Products, LLC | 2011-10-13 |
| BABI PLUS INFANT NASAL CANNULA SYSTEM (K110471) | A Plus Medical | 2011-10-07 |
| PRECISION FLOW(R) - HELIOX (K111640) | Vapotherm, Inc. | 2011-10-07 |
| OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE (K103625) | Draeger Medical Systems, Inc. | 2011-10-06 |
| SPEACELABS MULTIGAS MODULE (K112173) | Spacelabs Healthcare | 2011-10-05 |
| OXIMETRY INTERFACE KIT (K111378) | Philips Respironics, Inc. | 2011-10-04 |
| PHILIPS INTELLIVUE TCG10 (K110474) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-09-30 |
| MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR (K111570) | Thayer Medical Corporation | 2011-09-29 |