| VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack (K162758) | STERIS Corporation | 2017-03-21 |
| Sterile Single-use Syringe with Needle (K163161) | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-03-20 |
| Sterile Hypodermic Safety Syringes for Single Use (K163162) | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-03-20 |
| Safety Blood Collection Set (K163093) | Jiangsu Shenli Medical Production Co., Ltd. | 2017-03-14 |
| BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (K170336) | Becton, Dickinson and Company | 2017-03-10 |
| Infrared Non-contact Thermometer, Model ACT8100 (K162509) | Easywell Biomedicals, Inc. | 2017-03-10 |
| Q2 Low Pressure Power Injection Extension Set (K162804) | Quest Medical, Inc. | 2017-03-08 |
| Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set (K161898) | Beijing Fert Technology Co., Ltd. | 2017-03-08 |
| Nipro SafeTouch IV Catheter (K161681) | Nipro Medical Corporation | 2017-03-08 |
| Vial2Bag Direct Connect (K170095) | Medimop Medical Project , Ltd. | 2017-03-08 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K162646) | Hartalega NGC Sdn. Bhd. | 2017-03-03 |
| SREE MRI Transport Incubator (K161918) | Advanced Imaging Research Dba Sree Medical Systems | 2017-03-03 |
| BD Nexiva Diffusics Closed IV Catheter System (K170283) | Becton, Dickinson and Company | 2017-02-28 |
| Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) (K162982) | Medline Industries, Inc. | 2017-02-27 |
| BD PosiFlush Heparin Lock Flush Syringe (K163591) | Becton, Dickinson and Company | 2017-02-27 |
| DT-100 (K160358) | Mediana Co., Ltd. | 2017-02-24 |
| Arrow Endurance Extended Dwell Peripheral Catheter System (K163513) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2017-02-24 |
| Vesco Medical NRFit Tip Syringes (K170218) | Vesco Medical, LLC | 2017-02-24 |
| Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) (K163168) | Hebei Hongtai Plastic Products Company Limited | 2017-02-23 |
| Family of Steam sterilizers B17 B22 Series (K161848) | Cefla S.C. | 2017-02-23 |
| Medtronic Transportation/Sterilization Cassettes (K163279) | Medtronic Sofamor Danek USA, Inc. | 2017-02-23 |
| Powder Free Nitrile Examination Gloves, Black (K161099) | Pt. Maja Agung Latexindo | 2017-02-23 |
| Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) (K163126) | Blue Sail Medical Co.,Ltd | 2017-02-22 |
| Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E (K163041) | Pt. Medisafe Technologies | 2017-02-22 |
| STERRAD NX Sterilizer (K162007) | Advanced Sterilization Products | 2017-02-16 |
| POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs (K163146) | Hebei Hongsen Plastics Technology Co, Ltd. | 2017-02-13 |
| SteriTite Containers System & MediTray Products (K161415) | Case Medical, Inc. | 2017-02-10 |
| Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH (K161606) | Terumo Europe N.V. | 2017-02-10 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K162491) | Hartalega Sdn Bhd | 2017-02-08 |
| Transformair Indoor Air Purifier (K161468) | Transformair, LLC | 2017-02-08 |
| NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE (K162923) | Hartalega NGC Sdn. Bhd. | 2017-02-06 |
| PICC Maximal Barrier Nursing Kit (K163452) | Navilyst Medical, Inc. | 2017-02-03 |
| 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe (K161552) | Becton, Dickinson and Company | 2017-02-02 |
| NovaGuard SA Pro Safety System (K163511) | West Pharmaceutical Services, Inc. | 2017-02-02 |
| HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (K162381) | Healthy Glove Co., Ltd. | 2017-01-31 |
| VERIFY STEAM Integrating Indicator - Short (K162631) | STERIS Corporation | 2017-01-27 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) (K162924) | Hartalega Sdb. Bhd. | 2017-01-24 |
| Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe (K160589) | Certa Dose, Inc. | 2017-01-19 |
| Fever Scout™ Continuous Monitoring thermometer (K162137) | VivaLNK, Inc. | 2017-01-19 |
| meso-relle (AAL34, AAL36, AM30G) (K161255) | Biotekne Srl | 2017-01-19 |
| WellDoc BlueStar, WellDoc BlueStar Rx (K162532) | Welldoc, Inc. | 2017-01-12 |
| ConceptoMed Luer-Jack Slip 10ml (K162057) | Conceptomed AS | 2017-01-11 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K162818) | Hartalega Sdn Bhd | 2017-01-09 |
| RII Multi-function Infrared Thermometer, Model TH52Z (K162083) | Radiant Innovation, Inc. | 2017-01-09 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (K162819) | Hartalega Sdn Bhd | 2017-01-09 |
| Hospira Extension Set, Hospira Primary Set (K161036) | Hospira, Inc. | 2017-01-06 |
| Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) (K162146) | Brightway Holdings Sdn. Bhd. | 2017-01-05 |
| Disposable Insulin Syringe (K162180) | Berpu Medical Technology Co., Ltd. | 2016-12-29 |
| Hang&Go PAC (K161613) | Rand S.R.L. | 2016-12-28 |
| VPS Rhythm Device with TipTracker Technology (K160925) | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016-12-22 |
| ivWatch (K162478) | Ivwatch, LLC | 2016-12-22 |
| ulrich Transfer Set (K161723) | Ulrich GmbH & Co. KG | 2016-12-21 |
| Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs (K161215) | Brightway Holdings Sdn. Bhd. | 2016-12-21 |
| DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K162259) | Zibo Daiyang Plastic Company | 2016-12-21 |
| K3PRO SURGICAL TRAY (K160574) | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | 2016-12-20 |
| Paclitaxel Sets (K160007) | Baxter Healthcare Corporation | 2016-12-19 |
| Vinyl Exam Gloves, Powder Free, Clear (K161390) | Zibo Hongchin Plastic and Rubber Co., Ltd. | 2016-12-19 |
| BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe (K162081) | Becton, Dickinson and Company | 2016-12-19 |
| MRidium 3860+ MRI infusion Pump/ Monitoring System (K143369) | Iradimed Corporation | 2016-12-15 |
| PowerMidline Catheter (K162900) | C.R. Bard, Inc. | 2016-12-14 |
| Cloud Smart Thermometer (K160306) | Guangzhou Bosma Technology Co, Ltd. | 2016-12-13 |
| neoBLUE compact LED Phototherapy System (K160745) | Natus Medical Incorporated | 2016-12-12 |
| BD Pen Needle (K162516) | Becton, Dickinson and Company | 2016-12-09 |
| Jewel Precision Reusable Rigid Sterilization Container System (K162600) | Jewel Precision Sheet Metal & Machine, Inc. | 2016-12-09 |
| Hospira Sapphire Sets (K160492) | Hospira, Inc. | 2016-12-06 |
| Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets (K162304) | Quest Medical, Inc. | 2016-12-06 |
| OnSite-IV (K161800) | Pharmc, LLC | 2016-12-06 |
| Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 (K161728) | Microfile Intellectual Property GmbH | 2016-12-05 |
| SCIg60 Infuser (K161906) | Emed Technologies Corporation | 2016-12-01 |
| Solution Set for Epidural Use (K161323) | Baxter Healthcare Corporation | 2016-11-30 |
| Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink (K161932) | Terang Nusa Sdn Bhd | 2016-11-28 |
| WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (K162225) | Welldoc, Inc. | 2016-11-22 |
| Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less (K162175) | Vietglove Corporation | 2016-11-21 |
| Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs (K161944) | Shandong Baisheng Medical Products Co., Ltd. | 2016-11-21 |
| PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator (K160595) | Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti | 2016-11-18 |
| Non-contact Forehead Thermometer (K161735) | Shenzhen Dongdixin Technology Co., Ltd. | 2016-11-17 |
| Powder Free Nitrile Examination Gloves Flock-Lined, Black Color (K161074) | Shen Wei (Usa), Inc. | 2016-11-17 |
| AccuCath Intravascular Catheter (K162894) | C.R. Bard, Inc. | 2016-11-15 |
| Powder Free Nitrile Examination Gloves (Blue) (K162113) | Nam Viet Glove Joint Stock Company | 2016-11-07 |
| Barrier Supreme Sterilization Wrapper (K162162) | Standard Textile Co., Inc. | 2016-11-04 |
| MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter (K161779) | Medsource International, LLC | 2016-11-03 |
| Greiner Holdex (K160532) | Greiner Bio-One Na, Inc. | 2016-11-03 |
| Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) (K162095) | Yty Industry (Manjung) Sdn Bhd | 2016-11-02 |
| t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (K162080) | Tandem Diabetes Care, Inc. | 2016-10-25 |
| PowerPICC Provena Catheters (K162443) | C.R. Bard, Inc. | 2016-10-25 |
| DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K161422) | Wrp Asia Pacific Sdn. Bhd. | 2016-10-20 |
| Advocate Insulin Pen Needles (K160199) | Diabetic Supply of Suncoast, Inc. | 2016-10-19 |
| Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) (K161473) | Medline Industries, Inc. | 2016-10-19 |
| NovoPen Echo (K162602) | Novo Nordisk, Inc. | 2016-10-18 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (K160562) | Hartalega Snd. Bhd. | 2016-10-13 |
| Sterilization Tray (K160912) | STERIS Corporation | 2016-10-07 |
| Turbo-Flo PICC Sets (K161496) | Cook Incorporated | 2016-10-07 |
| Volumetric Infusion Controller (K153760) | DEKA Research & Development | 2016-10-03 |
| STERRAD® NX Sterilizer with ALLClear™ Technology (K160818) | Advanced Sterilization Products | 2016-09-27 |
| STERRAD 100NX Sterilizer with ALLClearTM Technology (K160903) | Advanced Sterilization Products | 2016-09-26 |
| PowerGlide Pro Midline Catheter (K162377) | C.R. Bard, Inc. | 2016-09-22 |
| MiniMed Quick-serter (K160860) | Medtronic Minimed | 2016-09-22 |
| CPL Insulin Pen Needle (K151090) | Cpl Co., Ltd. | 2016-09-21 |
| Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) (K160816) | Nexmed Technology Co., Ltd. | 2016-09-21 |
| Bone Solutions Mixing and Delivery System (K161568) | Bone Solutions, Inc. | 2016-09-16 |