| iSage Rx (iSage Rx Basal Insulin Titration) (K161865) | Isag Rx, Inc. | 2017-03-07 |
| MR Conditional CGA 870 (K162811) | Essex Industries, Inc. | 2017-03-02 |
| RTC 26-C Inline Aerosol Adapter (K162753) | Instrumentation Industries, Inc. | 2017-02-28 |
| Watch-PAT200U (K161579) | Itamar Medical , Ltd. | 2017-02-24 |
| TG-970P CO2 Sensor Kit (K161860) | Nihon Kohden Corporation | 2017-02-24 |
| MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM (K160837) | Medinet Srl | 2017-02-23 |
| EasyOne Pro Respiratory Analysis System (K161534) | Ndd Medizintechnik AG | 2017-02-22 |
| VibraPEP (K163091) | Medica Holdings, LLC | 2017-02-21 |
| Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set (K160200) | Cook Incorporated | 2017-02-17 |
| ReDe Mask (K161953) | Tereopneuma | 2017-02-17 |
| Care Cycle Connect Application (K161411) | Respironics, Inc. | 2017-02-17 |
| F&P InfoSmart (K161686) | Fisher & Paykel Healthcare, Ltd. | 2017-01-24 |
| Comfort Flo Humidification System (K162242) | Teleflexmedical, Inc. | 2017-01-19 |
| Juno VPAP ST-A (K161492) | Resmed, Ltd. | 2017-01-19 |
| F&P Brevida™ Nasal Pillows Mask (K161412) | Fisher & Paykel Healthcare, Ltd. | 2017-01-18 |
| MultiStim ECO (K162086) | PAJUNK GmbH Medizintechnologie | 2017-01-06 |
| EasyOne Air Spirometer (K161536) | Ndd Medizintechnik AG | 2017-01-05 |
| Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (K162423) | Haemonetics Corporation | 2017-01-03 |
| Go Dose System (K160949) | Eli Lilly and Company | 2016-12-22 |
| TRACOE Cuff Pressure Monitor (K152778) | Tracoe Medical GmbH | 2016-12-21 |
| Menai System (K160836) | Resmed, Ltd. | 2016-12-15 |
| Westmed Gas Sampling Cannula with O2 delivery (K162343) | Westmed, Inc. | 2016-12-14 |
| EZstim*III Peripheral Nerve Stimulator/Nerve Locator (K162048) | Halyard Health - Irvine | 2016-12-05 |
| TAV System (K152664) | New Aera, Inc. | 2016-12-02 |
| Walk-O2-Bout (K161472) | Essex Industries, Inc. | 2016-11-18 |
| AirFit N20 (K161978) | Resmed, Ltd. | 2016-11-17 |
| iCodeConnect (K160127) | 3B Medical, Inc. | 2016-11-10 |
| Insulia Diabetes Management Companion (K161433) | Voluntis Sa. | 2016-11-09 |
| Vivo 60 (K160481) | Breas Medical AB | 2016-11-09 |
| Propeller Sensor Model 2015-E (K161454) | Reciprocal Labs Corporation | 2016-11-01 |
| Tuohy NRFit (K160297) | PAJUNK GmbH Medizintechnologie | 2016-10-28 |
| SPROTTE SPECIAL NRFit (K160296) | PAJUNK GmbH Medizintechnologie | 2016-10-27 |
| SPROTTE NRFit, Quincke NRFit (K160295) | PAJUNK GmbH Medizintechnologie | 2016-10-27 |
| MaxBlend 2, MaxBlend Lite (K161718) | Maxtec, LLC | 2016-10-27 |
| SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles (K160294) | PAJUNK GmbH Medizintechnologie | 2016-10-21 |
| MiniBox + (K161295) | Pulmone Advanced Medical Devices, Ltd. | 2016-10-21 |
| Q13 SPIROLYSER® (K161676) | Fim Medical | 2016-10-20 |
| SpiroScout (K160116) | Ganshorn Medizin Electronic GmbH | 2016-10-07 |
| Arrow Epidural Catheter Kit (K161075) | Teleflexmedical, Inc. | 2016-10-04 |
| ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit (K161232) | Halyard Health | 2016-09-30 |
| TRACOE smart Cuff Manager (K152865) | Tracoe Medical GmbH | 2016-09-27 |
| Invacare Platinum Mobile Oxygen Concentrator (K160630) | Invacare Corporation | 2016-09-27 |
| Emergency Transtracheal Airway Catheter (K153761) | Cook Incorporated | 2016-09-22 |
| F&P Eson 2 Nasal Mask (K153505) | Fisher & Paykel Healthcare Limited | 2016-09-20 |
| VORTRAN Manometer (K153733) | Vortran Medical Technology 1, Inc. | 2016-09-16 |
| CATSmart (K160735) | Fresenius Kabi AG | 2016-09-16 |
| S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV (K160822) | Resmed, Ltd. | 2016-09-09 |
| VPAP Adapt SV, VPAP Tx, S9 VPAP Tx (K161487) | Resmed, Ltd. | 2016-09-09 |
| Luna CPAP and Auto CPAP System (K153387) | 3B Medical, Inc. | 2016-09-08 |
| HAMILTON-MR1 (K153046) | Hamilton Medical AG | 2016-09-06 |
| Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator (K152931) | Ambu A/S | 2016-08-29 |
| Vitalograph Model 6300 micro (K160253) | Vitalograph (Ireland) , Ltd. | 2016-08-26 |
| AirLife Autofill Humidification Chamber (K160764) | Carefusion 2200, Inc. | 2016-08-25 |
| MADgic Laryngo-Tracheal Mucosal Atomization Device (K153470) | Teleflex Medical | 2016-08-19 |
| Perifix and Contiplex Catheter (K153297) | B.Braun Medical, Inc. | 2016-08-12 |
| iPEP System and vPEP (K160636) | D R Burton Healthcare, LLC | 2016-08-03 |
| 5.0 Fr Arndt Endobronchial Blocker Set (K160542) | Cook Incorporated | 2016-08-02 |
| Watch-PAT200U (K153070) | Itamar Medical , Ltd. | 2016-07-26 |
| Hudson RCI AquaPak Sterile Prefilled Nebulizers (K153010) | Teleflexmedical, Inc. | 2016-07-26 |
| E-Cath (K152952) | PAJUNK GmbH Medizintechnologie | 2016-07-13 |
| AirLife Adult Heated Wire Circuit (K153234) | Carefusion, Inc. | 2016-07-07 |
| FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE (K161314) | Flexicare Medical Limited. | 2016-07-06 |
| Resmon PRO FULL (K152585) | Medical Graphics Corp. | 2016-06-24 |
| FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (K160540) | Flexicare Medical Limited. | 2016-06-23 |
| ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (K153652) | Teleflex, Inc. | 2016-06-21 |
| MaxO2ME (K153659) | Maxtec, LLC | 2016-06-10 |
| Endobronchial Tube (K152251) | Henan Tuoren Medical Device Co., Ltd. | 2016-06-10 |
| Wing Smart FEVI and Peak Flow Meter (K152276) | Sparo, Inc. | 2016-06-03 |
| Seal Rite Non-Rebreathing Valve (K152521) | The Lifeguard Store, Inc. | 2016-06-03 |
| Medipure Oxygen-LC System (K153518) | Praxair Distribution, Incorporated. | 2016-06-03 |
| O-PEP (K150044) | Pari Respiratory Equipment, Inc. | 2016-05-27 |
| Haemonetics Cell Saver Elite Autotransfusion System (K160197) | Haemonetics Corporation | 2016-05-24 |
| Astral 100/150 (K152068) | Resmed, Ltd. | 2016-05-13 |
| SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator (K153045) | Easy Med Instrument Co., Ltd. | 2016-05-13 |
| AirFit F20 (K153563) | Resmed, Ltd. | 2016-05-13 |
| EarlySense Insight Sytem (K152911) | Earlysense, Ltd. | 2016-05-06 |
| HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 (K152029) | Hamilton Medical AG | 2016-05-03 |
| AirFit N20 (K153673) | Resmed, Ltd. | 2016-05-02 |
| Besmed PEEP Valve (K160112) | Besmed Health Business Corp | 2016-04-29 |
| Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System (K152223) | Oxyheal Medical Systems, Inc. | 2016-04-29 |
| Simple T Pediatric Nasal Mask (K151120) | Respironics, Inc. | 2016-04-15 |
| BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal (K151874) | Salter Labs | 2016-04-15 |
| Juno VPAP ST-A (K153061) | Resmed, Ltd. | 2016-04-13 |
| SleepWeaver Advance Pediatric Nasal CPAP Mask (K151683) | Circadiance, LLC | 2016-04-05 |
| Flight 60 Ventilator (K143035) | Flight Medical Innovations , Ltd. | 2016-03-30 |
| Puritan Bennett 840 Series Ventilator System (K151252) | Covidien LP | 2016-03-29 |
| VibraPEP (K153441) | Medica Holdings, LLC | 2016-03-25 |
| Hybernite RT (K151461) | Plastiflex Group NV | 2016-03-24 |
| AUDICOR CA300/CC100 Analyzer with SDB (K151433) | Inovise Medical, Inc. | 2016-03-18 |
| MetaNeb 4 System (K151689) | Hill-Rom Services Pte, Ltd. | 2016-03-17 |
| Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula (K151506) | Salter Labs | 2016-03-11 |
| Thora-3Di, Model T-01 (K151940) | Pneumacare Limited | 2016-03-10 |
| Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines (K151421) | Salter Labs | 2016-03-10 |
| Propeller System (K152882) | Reciprocal Labs | 2016-03-08 |
| Medline Epidural Catheter (K150731) | Medline Industries, Inc. | 2016-03-07 |
| Propeller Sensor Model 2014-R (K152482) | Reciprocal Labs | 2016-03-04 |
| SPINAUT-E, SPINAUT-I (K150789) | Imedicom Co., Ltd. | 2016-03-01 |
| ETView VivaSight-SL (TVT) system (K152438) | Etview , Ltd. | 2016-02-25 |
| AnapnoGuard 100 Respiratory Guard System (K150157) | Hospitech Respiration , Ltd. | 2016-02-16 |
| ProTrach Dualcare (K151404) | Atos Medical AB | 2016-02-12 |