| Sure-Fine Insulin Syringes (K152879) | Shina Med Corporation | 2016-09-09 |
| EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs (K161187) | Eco Medi Glove Sdn. Bhd. | 2016-09-09 |
| BioFlo Midline Catheter (K161866) | Navilyst Medical, Inc. | 2016-09-08 |
| Next Science Irrigation Solution (K161165) | Next Science, LLC | 2016-09-07 |
| Signia sterilization tray (K161347) | Covidien | 2016-09-07 |
| CareSens Pen Needle, Softip Pen Needle (K160575) | Yidobio, Inc. | 2016-09-07 |
| HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (K160709) | Halyard Health | 2016-09-06 |
| CG+ Arrow JACC (K161765) | Arrow International, Inc. (Subsidiary of Teleflex | 2016-09-06 |
| Concert Medical Hands-Free Syringe (HFS) (K153599) | Concert Medical, LLC | 2016-09-01 |
| Cathtong I PICC Catheter (K153469) | L&Z Us, Inc. | 2016-09-01 |
| EMG Pink Nitrile Examination Glove Powder Free (K161320) | Eco Medi Glove Sdn. Bhd. | 2016-09-01 |
| Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) (K153193) | Zyno Medical, LLC | 2016-08-30 |
| Digital Thermometer (K161211) | Biocare Asia Corporation , Ltd. | 2016-08-29 |
| Insulin Pen Needle (K153706) | SteriLance Medical (Suzhou), Inc. | 2016-08-29 |
| BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems (K161777) | Becton Dickinson Infusion Therapy Systems, Inc. | 2016-08-29 |
| LifeFlow Rapid Infusion Device (LifeFlow Device) (K153731) | 410 Medical Innovation, LLC | 2016-08-25 |
| ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K161313) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-08-24 |
| Infrared Forehead Thermometer, FT-100A (K160802) | Hangzhou Universal Electronic Co., Ltd. | 2016-08-24 |
| Cavilon Advanced High Endurance Skin Protectant (K153571) | 3M Healthcare | 2016-08-23 |
| 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle (K162030) | Sol-Millennium Medical, Inc. | 2016-08-19 |
| PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set (K153440) | C.R. Bard, Inc. | 2016-08-18 |
| The Braun ThermoScan® 3 High Speed Compact Ear Thermometer (K161933) | Kaz USA, Inc., A Helen of Troy Company | 2016-08-16 |
| SUPERCATH 6 (K160592) | Togo Medikit Co., Ltd. | 2016-08-12 |
| MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (K160648) | Unomedical A/S | 2016-08-10 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System (K161683) | STERIS Corporation | 2016-08-05 |
| Triton System (K160338) | Gauss Surgical, Inc., | 2016-08-05 |
| Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators (K153540) | Safe Secure Packaging Co., Ltd. | 2016-08-04 |
| Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove (K161006) | Hartalega Sdn Bhd | 2016-08-04 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K160560) | Hartalega Sdn Bhd | 2016-08-04 |
| A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) (K153744) | A1 Glove Sdn Bhd | 2016-08-04 |
| Med-Tainer Single Deposit Container (K153274) | Snyder Industries, Inc. | 2016-08-04 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile (K151750) | Kossan International Sdn Bhd | 2016-08-03 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (K151824) | Kossan International Sdn Bhd | 2016-08-02 |
| Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim (K160467) | Kossan International Sdn Bhd | 2016-08-02 |
| Powder free vinyl patient examination glove, colored (yellow) (K160675) | Kaixing Plastic Products Co., Litd. | 2016-08-02 |
| Infra-red forehead thermometer (K160999) | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | 2016-08-01 |
| Powder Free Blue Nitrile Examination Glove (K153732) | Qube Medical Product Sdn Bhd | 2016-07-29 |
| Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (K160755) | Ahlstrom Nonwovens, LLC | 2016-07-27 |
| Atteris No-Sting Skin Protectant (K160684) | Rochal Industries, LLC | 2016-07-26 |
| Red2Green Reusable Sharps Container (K153363) | Triumvirate Environmental, Inc. | 2016-07-26 |
| Cook Intraosseous Infusion Needles (K160887) | Cook Incorporated | 2016-07-26 |
| InPen (K160629) | Companion Medical, Inc. | 2016-07-26 |
| Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating (K160411) | Cardinal Health, Inc. | 2016-07-25 |
| t:slim Insulin Delivery System (K160056) | Tandem Diabetes Care, Inc. | 2016-07-25 |
| Vis-U-All Low Temperature Sterilization Pouch/Tubing (K160908) | STERIS Corporation | 2016-07-22 |
| ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer (K152905) | Arc Devices Limited | 2016-07-20 |
| Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) (K160308) | Fudakang Industrial Co., Ltd. | 2016-07-15 |
| Powder Free Grey Vinyl Examination Gloves (K161072) | Zibo Flourish Trading Co., Ltd. | 2016-07-14 |
| t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (K160482) | Tandem Diabetes Care, Inc. | 2016-07-13 |
| SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE (K152803) | Sung Shim Medicare Co., Ltd. | 2016-07-12 |
| JSM Insulin Pen Needle (K152166) | Jeesung Medical Co., Ltd. | 2016-07-11 |
| BD U-500 INSULIN SYRINGE (K151870) | Becton, Dickinson and Company | 2016-07-08 |
| LITe BIO Delivery System (K160978) | Stryker Corporation | 2016-07-08 |
| Gemini Sterilization Wrap (K152564) | Medline Industries, Inc. | 2016-07-07 |
| V-PRO® 1 Plus and V-PRO® maX Low Temperature (K160433) | STERIS Corporation | 2016-07-06 |
| BD SafeAssist (K161553) | Becton, Dickinson and Company | 2016-07-06 |
| Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal (K153074) | Covidien | 2016-07-06 |
| ViaValve Safety I.V. Catheter (K160235) | Smiths Medical Asd, Inc. | 2016-06-30 |
| STERIZONE Sterilizer (K153689) | Tso3, Inc. | 2016-06-30 |
| Jeesung Safety Syringe and Single Use Needles (K152606) | Jeesung Medical Co., Ltd. | 2016-06-28 |
| PowerMidline Catheter (K153393) | C.R. Bard, Inc. | 2016-06-28 |
| Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape (K161024) | Canadian Technical Tape, Ltd. | 2016-06-28 |
| Unifine Pentips/ Unifine Pentips Plus (K152339) | Owen Mumford, Ltd. | 2016-06-24 |
| NIO-P (K160805) | Waismed, Ltd. | 2016-06-23 |
| QiF Blood and Fluid Warmer (K150404) | Quality IN Flow , Ltd. | 2016-06-23 |
| Synthetic Vinyl Examination Gloves, Powder-Free, Yellow (K160468) | Inpro Technology Device Factory | 2016-06-23 |
| EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented (K152937) | Eco Medi Glove Sdn. Bhd. | 2016-06-23 |
| CliniCloud Non-contact Thermometer, Model SPL1024 (K161325) | Stethocloud Pty.Ltd (Clinicloud) | 2016-06-22 |
| DermaTherapy Bed Linens (K152884) | Precision Fabrics Group, Inc. | 2016-06-20 |
| Withings Thermo (Model SCT01) (K160544) | Withings | 2016-06-17 |
| Sol-M Insulin Syringe, Sol-M TB Syringe (K153537) | Sol-Millennium Medical, Inc. | 2016-06-17 |
| PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter (K151985) | C.R. Bard, Inc. | 2016-06-14 |
| Airborne Phototherapy Light (K160238) | International Biomedical | 2016-06-14 |
| Oak Ridge Products Sharps Containers (K161180) | Oak Ridge Products, LLC | 2016-06-09 |
| 3M Attest Rapid Readout Biological Indicator (K160546) | 3M Company | 2016-06-09 |
| ProteXsure Safety Capsule System (K152597) | Starcap Medical, LLC ( Dba Prism Medical & Design) | 2016-06-08 |
| SureFine Pen Needle (K152877) | Shina Med Corporation | 2016-06-07 |
| IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle (K153388) | Guangzhou Improve Medical Instruments Co., Ltd. | 2016-06-07 |
| Smart Set (K151250) | Top Spins, Inc. | 2016-06-07 |
| NMI DUAL PORT II (K151239) | Navilyst Medical, Inc. | 2016-06-06 |
| HumaPen Savvio (K160668) | Eli Lilly and Company, Inc. | 2016-06-03 |
| PowerGlide Pro Midline Catheter (K153280) | C.R. Bard, Inc. | 2016-06-02 |
| Hospira Administration Sets (K160870) | Hospira, Inc. | 2016-06-01 |
| VERIFY VH2O2 Indicator Tape (K160485) | STERIS Corporation | 2016-06-01 |
| Gemini Bonded Sterilization Wrap (K152458) | Medline Industries, Inc. | 2016-06-01 |
| NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six (K152340) | North American Rescue, LLC | 2016-05-31 |
| BD Eclipse Hypodermic Needle (K161170) | Becton, Dickinson and Company | 2016-05-27 |
| Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 (K153149) | Sejoy Electronics & Instruments Co., Ltd. | 2016-05-27 |
| neoBLUE® LED Phototherapy System (K160305) | Natus Medical Incorporated | 2016-05-27 |
| Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves (K152818) | Ideal Plastic Co., Ltd. | 2016-05-26 |
| Temperature Probe, Affinity Temperature Probe (K160091) | Medtronic, Inc. | 2016-05-20 |
| BardPort®, SlimPort®, and X-Port® Implanted Ports (K153359) | C.R. Bard, Inc. | 2016-05-20 |
| SiO2 Coated syringe 3 ml (K153553) | Sio2 Medical Products | 2016-05-17 |
| ReNew Sterilization Trays(Catalog #3708 and #3709) (K152745) | Microline Surgical, Inc. | 2016-05-12 |
| VERIFY STEAM Integrating Indicator (K152630) | STERIS Corporation | 2016-05-12 |
| TD-1035 Thermometer (K152680) | Taidoc Technology Corporation | 2016-05-06 |
| Vented Vial Adapter Transfer Device - 13mm (K160503) | Medimop Medical Projects, Ltd. | 2016-05-04 |
| Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (K151390) | Maxter Glove Manufacturing Sdn Bhd | 2016-05-02 |
| OmniPod Insulin Management System (K160252) | Insulet Corporation | 2016-04-27 |
| NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs (K152222) | Gmp Medicare Sdn Bhd (F25) | 2016-04-21 |