| Astral 100/150 (K172875) | Resmed, Ltd. | 2018-04-26 |
| StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle (K173321) | Teleflex Medical | 2018-04-25 |
| Frova Intubating Introducer (K171917) | Cook Incorporated | 2018-04-23 |
| Panoramic Oxygen Mask (POM) (K172365) | Pom Medical, LLC | 2018-04-19 |
| Precision Flow® HVNI (DEN170001) | Vapotherm, Inc. | 2018-04-10 |
| BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (K173384) | Smiths Medical Ads, Inc. | 2018-04-10 |
| Medicant Mucosal Atomizer (K172956) | Medica Holdings, LLC | 2018-04-06 |
| Bleep DreamPort (K172335) | Snapcpap | 2018-03-30 |
| TwitchView System (K172843) | Blink Device Corporation | 2018-03-29 |
| SmartTouch (K173310) | Adherium (Nz), Ltd. | 2018-03-26 |
| Drive DeVilbiss iGo 2 Portable Oxygen Concentrator (K172648) | Devilbiss Healthcare, LLC | 2018-03-23 |
| ExSpiron 1Xi (K173181) | Respiratory Motion, Inc. | 2018-03-16 |
| Positional Sleep Assessment System (PoSAS) software (K172799) | Advanced Brain Monitoring | 2018-03-09 |
| CO Check Pro, CO Screen (K171129) | MD Diagnostics Limited | 2018-03-02 |
| MC 300* Nebulizer (K173367) | Trudell Medical International | 2018-02-28 |
| NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet (K172208) | Nevap, Inc. | 2018-02-16 |
| NAPA LP-15 Airway Pressure Monitor (K172284) | Drw Medical, LLC | 2018-02-09 |
| IMD's Lumbar Puncture Needle (K170112) | International Medical Development, Inc.(Imd) | 2018-02-02 |
| Glooko Mobile Insulin Dosing System (K171450) | Glooko, Inc. | 2018-02-02 |
| EchoGlo Needle (K171968) | Smiths Medical Asd, Inc. | 2018-01-25 |
| F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (K173060) | Fisher and Paykel Healthcare Limited | 2018-01-25 |
| ReddyPort NIV Access Elbow (K171827) | Smd Manufacturing, LLC | 2018-01-19 |
| Endotracheal tube; Reinforced Endotracheal tube (K170234) | Zhanjiang Star Enterprise Co., Ltd. | 2018-01-17 |
| A5 Anesthesia System (K171311) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 |
| A7 Anesthesia System (K171292) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 |
| IRRIS (Infra-Red-Red Intubation System) (K171411) | A.R Guide IN Medical , Ltd. | 2018-01-12 |
| Besmed Peak Flow Meter (K172804) | Besmed Health Business Corp | 2018-01-11 |
| Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles (K171518) | Zhejiang Kindly Medical Devices Co., Ltd. | 2018-01-05 |
| EarlySense Bed Sensing Unit (K171836) | Earlysense, Ltd. | 2018-01-04 |
| OmniCap (K171235) | Respirion, Inc. | 2018-01-04 |
| Tec 820, Tec 850 (K172702) | Datex-Ohmeda, Inc. | 2018-01-04 |
| AirFit F20 (K170924) | Resmed, Ltd. | 2018-01-03 |
| IntelliVue Capnography Extension, IntelliVue Microstream Extension (K172904) | Philips Medizin Systeme Boeblingen GmbH | 2017-12-26 |
| B. Braun Tear-Away Introducer Needle (K171584) | B.Braun Medical, Inc. | 2017-12-22 |
| VPOD ITPR (K172388) | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017-12-22 |
| Certa Catheter (K171193) | Ferrosan Medical Devices Sp. Z.O.O. | 2017-12-18 |
| Portex Blue Line Ultra Paediatric Tracheosomy Tube (K170720) | Smiths Medical Asd, Inc. | 2017-12-07 |
| Portable Nebulizer (K170916) | Microbase Technology Corporation | 2017-11-28 |
| Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) (K171961) | Xiamen Compower Medical Tech. Co., Ltd. | 2017-11-17 |
| SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer (K170071) | Sleep Group Solutions | 2017-11-09 |
| Insulia Diabetes Management Companion (K172177) | Voluntis Sa. | 2017-11-07 |
| Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 (K172045) | Datex-Ohmeda, Inc. | 2017-11-03 |
| InnoSpire Go (K170853) | Respironics Respiratory Drug Delivery (Uk) , Ltd. | 2017-11-02 |
| Puritan Bennett 980 Ventilator System (K162738) | Covidien | 2017-10-27 |
| SuperNO2VA Device (K163277) | Revolutionary Medical Devices, Inc. | 2017-10-13 |
| SleepImage System (K163696) | Mycardio, LLC Dba Sleepimage. | 2017-10-13 |
| Nihon Kohden CO2 Monitor (K171765) | Nihon Kohden Corporation | 2017-10-11 |
| MSA100BT Peak Flow Meter (K170281) | Beijing M&B Electronic Instruments Co., Ltd. | 2017-10-06 |
| Carbon Monoxide Breath Sensor System (COBSS) (K171408) | Carrot Sense, Inc. | 2017-09-29 |
| AirFit N20 (K171212) | Resmed, Ltd. | 2017-09-28 |
| Salter Labs Bubble Humidifier (K161719) | Salter Labs | 2017-09-21 |
| HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 (K163283) | Hamilton Medical AG | 2017-09-20 |
| Health-e-Connect System with IDA (K163664) | Alr Technologies | 2017-09-18 |
| AirLife Adult Heated Wire BiPAP/NIV Circuit (K170378) | Vyaire Medical | 2017-09-14 |
| tremoFlo C-100 Airwave Oscillometry System (K170185) | Thorasys Thoracic Medical Systems, Inc. | 2017-09-12 |
| Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford (K163292) | Spectra Medical Devices | 2017-09-08 |
| The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) (K161586) | Shenzhen Homed Medical Device Co., Ltd. | 2017-09-06 |
| Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) (K163464) | Bmc Medical., Ltd. | 2017-09-05 |
| SmartTouch (K163485) | Adherium (Nz), Ltd. | 2017-08-30 |
| Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small (K170367) | Fisher and Paykel Healthcare Limited | 2017-08-24 |
| CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories (K171028) | GE Healthcare Finland Oy | 2017-08-17 |
| Aisys CS2 (K170872) | Datex-Ohmeda, Inc. | 2017-08-15 |
| Breathe Technologies Life2000™ Ventilation System (K170037) | Breathe Technologies | 2017-08-11 |
| Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip (K162729) | Cook Incorporated | 2017-08-11 |
| Glucommander (K152300) | Glytec, LLC | 2017-08-04 |
| 731 Series Ventilators (K162832) | ZOLL Medical Corporation | 2017-08-02 |
| bellavista 1000 (K163127) | Imtmedical AG | 2017-07-31 |
| NerveGuard NRFit, NerveGuard LUER (K170435) | PAJUNK GmbH Medizintechnologie | 2017-07-12 |
| Pinpoint GT Needles (K163216) | C.R. Bard, Inc. | 2017-06-27 |
| Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (K163412) | Girgis Scope, LLC | 2017-06-22 |
| COSMED K5 Wearable Metabolic Technology (K162515) | Cosmed Srl | 2017-06-20 |
| Insulia Diabetes Management Companion (K170669) | Voluntis Sa. | 2017-06-19 |
| Insulin Algorithms System (K160673) | Insulin Algorithms | 2017-06-07 |
| MOVES SLC (K161420) | Thornhill Research, Inc. | 2017-06-06 |
| My Dose Coach (K171230) | Sanofi | 2017-05-26 |
| GCE Zen-O Portable Oxygen Concentrator (K162433) | Oxus, Inc. | 2017-05-24 |
| Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber (K160109) | Thayer Medical Corporation | 2017-05-19 |
| Frova Intubating Introducer (K161813) | William Cook Europe Aps | 2017-05-19 |
| AirLife Misty Finity Nebulizer (K153748) | Care Fusion | 2017-05-17 |
| ExSpiron 1Xi (K162131) | Respiratory Motion, Inc. | 2017-05-09 |
| MATRx plus (K163665) | Zephyr Sleep Technologies | 2017-05-05 |
| MINISCAV (K160950) | Sedation Systems, LLC | 2017-05-05 |
| Airworks Nebulizer pe1200m (K162041) | Convexity Scientific, LLC | 2017-05-02 |
| HAMILTON-C3 (K161450) | Hamilton Medical AG | 2017-04-27 |
| Apnea Risk Evaluation System (ARES), Model 620 (K160499) | Watermark Medical | 2017-04-24 |
| Velox Nebulizer System (K162785) | Pari Respiratory Equipment, Inc. | 2017-04-14 |
| Intelli-Ox (K161179) | Air Liquide Healthcare America Corporation | 2017-04-13 |
| VORTRAN GO2VENT (K162968) | Vortran Medical Technology 1, Inc. | 2017-04-10 |
| Disposable Endotracheal tube, sterile, AccuCuff (K160694) | Tianjin Medis Medical Device Co., Ltd. | 2017-04-07 |
| VOCSN Unified Respiratory System (K162877) | Ventec Life Systems, Inc. | 2017-04-07 |
| Entellus Medical Reinforced Anesthesia Needle (K163435) | Entellus Medical, Inc. | 2017-04-05 |
| FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 (K160665) | Maquet Critical Care AB | 2017-03-29 |
| GoSpiro (K163249) | Monitored Therapeutics, Inc. | 2017-03-24 |
| My Dose Coach (K163099) | Sanofi, Inc. | 2017-03-22 |
| OxyHeal 4000 Multiplace Hyperbaric Chamber Family (K163109) | Oxyheal Medical Systems, Inc. | 2017-03-22 |
| ThermoShield HME Filter (K163300) | Flexicare Medical Limited. | 2017-03-22 |
| UltraCath Continuous Nerve block Catheter (K162522) | Teleflexmedical, Inc. | 2017-03-17 |
| OC-FLEX Flexible IntraOral Cannula (K161250) | Venture Therapeutics, Inc. | 2017-03-17 |
| Monarch Airway Clearance System (K163378) | Hill-Rom Services Pte, Ltd. | 2017-03-17 |
| SleepWeaver 3D Nasal Mask (K162905) | Circadiance, LLC | 2017-03-15 |