Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 31
- Latest Decision
- 2016-11-15
Clearances · page 25 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K162894 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | FOZ | Class II | 2016-11-15 |
| K162113 | Powder Free Nitrile Examination Gloves (Blue) | Nam Viet Glove Joint Stock Company | LZA | Class I | 2016-11-07 |
| K162162 | Barrier Supreme Sterilization Wrapper | Standard Textile Co., Inc. | FRG | Class II | 2016-11-04 |
| K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter | Medsource International, LLC | FOZ | Class II | 2016-11-03 |
| K160532 | Greiner Holdex | Greiner Bio-One Na, Inc. | FMI | Class II | 2016-11-03 |
| K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | Yty Industry (Manjung) Sdn Bhd | LZA | Class I | 2016-11-02 |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | LZG | Class II | 2016-10-25 |
| K162443 | PowerPICC Provena Catheters | C.R. Bard, Inc. | LJS | Class II | 2016-10-25 |
| K161422 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Wrp Asia Pacific Sdn. Bhd. | LZA | Class I | 2016-10-20 |
| K160199 | Advocate Insulin Pen Needles | Diabetic Supply of Suncoast, Inc. | FMI | Class II | 2016-10-19 |
| K161473 | Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) | Medline Industries, Inc. | LZA | Class I | 2016-10-19 |
| K162602 | NovoPen Echo | Novo Nordisk, Inc. | FMF | Class II | 2016-10-18 |
| K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs | Hartalega Snd. Bhd. | LZA | Class I | 2016-10-13 |
| K161496 | Turbo-Flo PICC Sets | Cook Incorporated | LJS | Class II | 2016-10-07 |
| K160912 | Sterilization Tray | STERIS Corporation | KCT | Class II | 2016-10-07 |
| K153760 | Volumetric Infusion Controller | DEKA Research & Development | LDR | Class II | 2016-10-03 |
| K160818 | STERRAD® NX Sterilizer with ALLClear Technology | Advanced Sterilization Products | MLR | Class II | 2016-09-27 |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | Advanced Sterilization Products | MLR | Class II | 2016-09-26 |
| K160860 | MiniMed Quick-serter | Medtronic Minimed | KZH | Class II | 2016-09-22 |
| K162377 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | FOZ | Class II | 2016-09-22 |
| K151090 | CPL Insulin Pen Needle | Cpl Co., Ltd. | FMI | Class II | 2016-09-21 |
| K160816 | Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) | Nexmed Technology Co., Ltd. | FLL | Class II | 2016-09-21 |
| K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | FMF | Class II | 2016-09-16 |
| K152879 | Sure-Fine Insulin Syringes | Shina Med Corporation | FMF | Class II | 2016-09-09 |
| K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2016-09-09 |
| K161866 | BioFlo Midline Catheter | Navilyst Medical, Inc. | FOZ | Class II | 2016-09-08 |
| K161165 | Next Science Irrigation Solution | Next Science, LLC | FQH | Class II | 2016-09-07 |
| K161347 | Signia sterilization tray | Covidien | KCT | Class II | 2016-09-07 |
| K160575 | CareSens Pen Needle, Softip Pen Needle | Yidobio, Inc. | FMI | Class II | 2016-09-07 |
| K161765 | CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex | LJS | Class II | 2016-09-06 |
| K160709 | HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves | Halyard Health | LZC | Class I | 2016-09-06 |
| K161320 | EMG Pink Nitrile Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2016-09-01 |
| K153469 | Cathtong I PICC Catheter | L&Z Us, Inc. | LJS | Class II | 2016-09-01 |
| K153599 | Concert Medical Hands-Free Syringe (HFS) | Concert Medical, LLC | FRN | Class II | 2016-09-01 |
| K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) | Zyno Medical, LLC | FRN | Class II | 2016-08-30 |
| K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2016-08-29 |
| K161211 | Digital Thermometer | Biocare Asia Corporation , Ltd. | FLL | Class II | 2016-08-29 |
| K153706 | Insulin Pen Needle | SteriLance Medical (Suzhou), Inc. | FMI | Class II | 2016-08-29 |
| K153731 | LifeFlow Rapid Infusion Device (LifeFlow Device) | 410 Medical Innovation, LLC | FPA | Class II | 2016-08-25 |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | PND | Class II | 2016-08-24 |
| K160802 | Infrared Forehead Thermometer, FT-100A | Hangzhou Universal Electronic Co., Ltd. | FLL | Class II | 2016-08-24 |
| K153571 | Cavilon Advanced High Endurance Skin Protectant | 3M Healthcare | KMF | Class I | 2016-08-23 |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | Sol-Millennium Medical, Inc. | MEG | Class II | 2016-08-19 |
| K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set | C.R. Bard, Inc. | FPA | Class II | 2016-08-18 |
| K161933 | The Braun ThermoScan® 3 High Speed Compact Ear Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | 2016-08-16 |
| K160592 | SUPERCATH 6 | Togo Medikit Co., Ltd. | FOZ | Class II | 2016-08-12 |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | Unomedical A/S | FPA | Class II | 2016-08-10 |
| K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | MED | Class II | 2016-08-05 |
| K160338 | Triton System | Gauss Surgical, Inc., | PBZ | Class II | 2016-08-05 |
| K160560 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | Hartalega Sdn Bhd | LZA | Class I | 2016-08-04 |
| K153274 | Med-Tainer Single Deposit Container | Snyder Industries, Inc. | MMK | Class II | 2016-08-04 |
| K153744 | 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) | A1 Glove Sdn Bhd | LYY | Class I | 2016-08-04 |
| K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | Safe Secure Packaging Co., Ltd. | FRG | Class II | 2016-08-04 |
| K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | Hartalega Sdn Bhd | LYY | Class I | 2016-08-04 |
| K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile | Kossan International Sdn Bhd | LZA | Class I | 2016-08-03 |
| K151824 | 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 | Kossan International Sdn Bhd | LZA | Class I | 2016-08-02 |
| K160467 | Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | Kossan International Sdn Bhd | LZA | Class I | 2016-08-02 |
| K160675 | Powder free vinyl patient examination glove, colored (yellow) | Kaixing Plastic Products Co., Litd. | LYZ | Class I | 2016-08-02 |
| K160999 | Infra-red forehead thermometer | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | FLL | Class II | 2016-08-01 |
| K153732 | Powder Free Blue Nitrile Examination Glove | Qube Medical Product Sdn Bhd | LZA | Class I | 2016-07-29 |
| K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens, LLC | FRG | Class II | 2016-07-27 |
| K153363 | Red2Green Reusable Sharps Container | Triumvirate Environmental, Inc. | MMK | Class II | 2016-07-26 |
| K160629 | InPen | Companion Medical, Inc. | FMF | Class II | 2016-07-26 |
| K160684 | Atteris No-Sting Skin Protectant | Rochal Industries, LLC | KMF | Class I | 2016-07-26 |
| K160887 | Cook Intraosseous Infusion Needles | Cook Incorporated | FMI | Class II | 2016-07-26 |
| K160411 | Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating | Cardinal Health, Inc. | LYZ | Class I | 2016-07-25 |
| K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | LZG | Class II | 2016-07-25 |
| K160908 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | STERIS Corporation | FRG | Class II | 2016-07-22 |
| K152905 | ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer | Arc Devices Limited | FLL | Class II | 2016-07-20 |
| K160308 | Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) | Fudakang Industrial Co., Ltd. | FLL | Class II | 2016-07-15 |
| K161072 | Powder Free Grey Vinyl Examination Gloves | Zibo Flourish Trading Co., Ltd. | LYZ | Class I | 2016-07-14 |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | LZG | Class II | 2016-07-13 |
| K152803 | SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE | Sung Shim Medicare Co., Ltd. | FMF | Class II | 2016-07-12 |
| K152166 | JSM Insulin Pen Needle | Jeesung Medical Co., Ltd. | FMI | Class II | 2016-07-11 |
| K160978 | LITe BIO Delivery System | Stryker Corporation | FMF | Class II | 2016-07-08 |
| K151870 | BD U-500 INSULIN SYRINGE | Becton, Dickinson and Company | FMF | Class II | 2016-07-08 |
| K152564 | Gemini Sterilization Wrap | Medline Industries, Inc. | FRG | Class II | 2016-07-07 |
| K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature | STERIS Corporation | MLR | Class II | 2016-07-06 |
| K161553 | BD SafeAssist | Becton, Dickinson and Company | FMI | Class II | 2016-07-06 |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal | Covidien | LZH | Class II | 2016-07-06 |
| K160235 | ViaValve Safety I.V. Catheter | Smiths Medical Asd, Inc. | FOZ | Class II | 2016-06-30 |
| K153689 | STERIZONE Sterilizer | Tso3, Inc. | PJJ | Class II | 2016-06-30 |
| K152606 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | MEG | Class II | 2016-06-28 |
| K153393 | PowerMidline Catheter | C.R. Bard, Inc. | PND | Class II | 2016-06-28 |
| K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape | Canadian Technical Tape, Ltd. | JOJ | Class II | 2016-06-28 |
| K152339 | Unifine Pentips/ Unifine Pentips Plus | Owen Mumford, Ltd. | FMI | Class II | 2016-06-24 |
| K160805 | NIO-P | Waismed, Ltd. | FMI | Class II | 2016-06-23 |
| K150404 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | LGZ | Class II | 2016-06-23 |
| K152937 | EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2016-06-23 |
| K160468 | Synthetic Vinyl Examination Gloves, Powder-Free, Yellow | Inpro Technology Device Factory | LYZ | Class I | 2016-06-23 |
| K161325 | CliniCloud Non-contact Thermometer, Model SPL1024 | Stethocloud Pty.Ltd (Clinicloud) | FLL | Class II | 2016-06-22 |
| K152884 | DermaTherapy Bed Linens | Precision Fabrics Group, Inc. | FMW | Class I | 2016-06-20 |
| K160544 | Withings Thermo (Model SCT01) | Withings | FLL | Class II | 2016-06-17 |
| K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | Sol-Millennium Medical, Inc. | FMF | Class II | 2016-06-17 |
| K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter | C.R. Bard, Inc. | LJS | Class II | 2016-06-14 |
| K160238 | Airborne Phototherapy Light | International Biomedical | LBI | Class II | 2016-06-14 |
| K160546 | 3M Attest Rapid Readout Biological Indicator | 3M Company | FRC | Class II | 2016-06-09 |
| K161180 | Oak Ridge Products Sharps Containers | Oak Ridge Products, LLC | MMK | Class II | 2016-06-09 |
| K152597 | ProteXsure Safety Capsule System | Starcap Medical, LLC ( Dba Prism Medical & Design) | FMI | Class II | 2016-06-08 |
| K152877 | SureFine Pen Needle | Shina Med Corporation | FMI | Class II | 2016-06-07 |
15,723 clearances in the General Hospital panel. Data: openFDA.