Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 35
- Latest Decision
- 2017-04-21
Clearances · page 24 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K163516 | Braun No Touch + Forehead NTF3000 Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | 2017-04-21 |
| K163708 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | LGZ | Class II | 2017-04-20 |
| K161910 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | FRG | Class II | 2017-04-20 |
| K163160 | Sterile Single-use Infusion Set | Jiangxi Hongda Medical Equipment Group , Ltd. | FPA | Class II | 2017-04-20 |
| K160680 | VisioFocus Mini, VisioFocus Smart | Tecnimed S.R.L. | FLL | Class II | 2017-04-19 |
| K162296 | OmniPod Insulin Management System | Insulet Corporation | LZG | Class II | 2017-04-18 |
| K163001 | PowerFlow Apheresis I.V. Port | C.R. Bard, Inc. | PTD | Class II | 2017-04-17 |
| K170386 | BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine needle and BD Insulin Syringes with Micro-Fine IV Needle | Becton Dickinson & Company | FMF | Class II | 2017-04-12 |
| K163144 | gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) | Gke-GmbH | FRC | Class II | 2017-04-07 |
| K163256 | Dual Mode Infrared Thermometer | Intelliworks, LLC | FLL | Class II | 2017-04-06 |
| K162186 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM | Brightway Holdings Sdn. Bhd. | LZC | Class I | 2017-03-31 |
| K162626 | THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE | Top Quality Glove Sdn. Bhd | LZA | Class I | 2017-03-31 |
| K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | STERIS Corporation | MLR | Class II | 2017-03-31 |
| K161929 | Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove | Dipped Products (Thailand) Limited | LZA | Class I | 2017-03-29 |
| K162405 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) | Comfort Rubber Gloves Industries Sdn. Bhd. | LZA | Class I | 2017-03-28 |
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | FRN | Class II | 2017-03-28 |
| K161667 | Sapphire Infusion Pump | Q Core Medical , Ltd. | FRN | Class II | 2017-03-27 |
| K161812 | Freedom Syringe | Procedure Products, Inc. | FMF | Class II | 2017-03-27 |
| K163267 | NITRILE EXAMINATION GLOVE | Brightway Holdings Sdn. Bhd. | LZA | Class I | 2017-03-24 |
| K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | STERIS Corporation | OWP | Class II | 2017-03-24 |
| K162701 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | OWP | Class II | 2017-03-24 |
| K163017 | Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs | Gmp Medicare Sdn. Bhd. | LZC | Class I | 2017-03-22 |
| K163401 | Nix Ultra Lice Treatment Kit | Medtech Products, Inc. | LJL | Class I | 2017-03-21 |
| K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack | STERIS Corporation | JOJ | Class II | 2017-03-21 |
| K163161 | Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group , Ltd. | FMF | Class II | 2017-03-20 |
| K163162 | Sterile Hypodermic Safety Syringes for Single Use | Jiangxi Hongda Medical Equipment Group , Ltd. | MEG | Class II | 2017-03-20 |
| K163093 | Safety Blood Collection Set | Jiangsu Shenli Medical Production Co., Ltd. | FMI | Class II | 2017-03-14 |
| K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector | Becton, Dickinson and Company | FOZ | Class II | 2017-03-10 |
| K162509 | Infrared Non-contact Thermometer, Model ACT8100 | Easywell Biomedicals, Inc. | FLL | Class II | 2017-03-10 |
| K161898 | Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set | Beijing Fert Technology Co., Ltd. | FPA | Class II | 2017-03-08 |
| K170095 | Vial2Bag Direct Connect | Medimop Medical Project , Ltd. | LHI | Class II | 2017-03-08 |
| K161681 | Nipro SafeTouch IV Catheter | Nipro Medical Corporation | FOZ | Class II | 2017-03-08 |
| K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | FPA | Class II | 2017-03-08 |
| K161918 | SREE MRI Transport Incubator | Advanced Imaging Research Dba Sree Medical Systems | FPL | Class II | 2017-03-03 |
| K162646 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2017-03-03 |
| K170283 | BD Nexiva Diffusics Closed IV Catheter System | Becton, Dickinson and Company | FOZ | Class II | 2017-02-28 |
| K162982 | Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. | LZA | Class I | 2017-02-27 |
| K163591 | BD PosiFlush Heparin Lock Flush Syringe | Becton, Dickinson and Company | NZW | Class II | 2017-02-27 |
| K160358 | DT-100 | Mediana Co., Ltd. | FLL | Class II | 2017-02-24 |
| K170218 | Vesco Medical NRFit Tip Syringes | Vesco Medical, LLC | FMF | Class II | 2017-02-24 |
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | FOZ | Class II | 2017-02-24 |
| K163168 | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) | Hebei Hongtai Plastic Products Company Limited | LYZ | Class I | 2017-02-23 |
| K161099 | Powder Free Nitrile Examination Gloves, Black | Pt. Maja Agung Latexindo | LZA | Class I | 2017-02-23 |
| K161848 | Family of Steam sterilizers B17 B22 Series | Cefla S.C. | FLE | Class II | 2017-02-23 |
| K163279 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | KCT | Class II | 2017-02-23 |
| K163126 | Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) | Blue Sail Medical Co.,Ltd | LZA | Class I | 2017-02-22 |
| K163041 | Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E | Pt. Medisafe Technologies | LZA | Class I | 2017-02-22 |
| K162007 | STERRAD NX Sterilizer | Advanced Sterilization Products | MLR | Class II | 2017-02-16 |
| K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | LZC | Class I | 2017-02-13 |
| K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH | Terumo Europe N.V. | FMF | Class II | 2017-02-10 |
| K161415 | SteriTite Containers System & MediTray Products | Case Medical, Inc. | FRG | Class II | 2017-02-10 |
| K162491 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Hartalega Sdn Bhd | LZA | Class I | 2017-02-08 |
| K161468 | Transformair Indoor Air Purifier | Transformair, LLC | FRA | Class II | 2017-02-08 |
| K162923 | 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 | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2017-02-06 |
| K163452 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | LJS | Class II | 2017-02-03 |
| K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe | Becton, Dickinson and Company | NGT | Class II | 2017-02-02 |
| K163511 | NovaGuard SA Pro Safety System | West Pharmaceutical Services, Inc. | MEG | Class II | 2017-02-02 |
| K162381 | HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs | Healthy Glove Co., Ltd. | LZA | Class I | 2017-01-31 |
| K162631 | VERIFY STEAM Integrating Indicator - Short | STERIS Corporation | JOJ | Class II | 2017-01-27 |
| K162924 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) | Hartalega Sdb. Bhd. | LZA | Class I | 2017-01-24 |
| K162137 | Fever Scout Continuous Monitoring thermometer | VivaLNK, Inc. | FLL | Class II | 2017-01-19 |
| K160589 | Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe | Certa Dose, Inc. | PQX | Class II | 2017-01-19 |
| K161255 | meso-relle (AAL34, AAL36, AM30G) | Biotekne Srl | FMI | Class II | 2017-01-19 |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | MRZ | Class II | 2017-01-12 |
| K162057 | ConceptoMed Luer-Jack Slip 10ml | Conceptomed AS | FMF | Class II | 2017-01-11 |
| K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | Radiant Innovation, Inc. | FLL | Class II | 2017-01-09 |
| K162819 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs | Hartalega Sdn Bhd | LZA | Class I | 2017-01-09 |
| K162818 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | Hartalega Sdn Bhd | LZA | Class I | 2017-01-09 |
| K161036 | Hospira Extension Set, Hospira Primary Set | Hospira, Inc. | FPA | Class II | 2017-01-06 |
| K162146 | Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) | Brightway Holdings Sdn. Bhd. | LZA | Class I | 2017-01-05 |
| K162180 | Disposable Insulin Syringe | Berpu Medical Technology Co., Ltd. | FMF | Class II | 2016-12-29 |
| K161613 | Hang&Go PAC | Rand S.R.L. | LGZ | Class II | 2016-12-28 |
| K162478 | ivWatch | Ivwatch, LLC | PMS | Class II | 2016-12-22 |
| K160925 | VPS Rhythm Device with TipTracker Technology | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | LJS | Class II | 2016-12-22 |
| K162259 | DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Zibo Daiyang Plastic Company | LYZ | Class I | 2016-12-21 |
| K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs | Brightway Holdings Sdn. Bhd. | LZA | Class I | 2016-12-21 |
| K161723 | ulrich Transfer Set | Ulrich GmbH & Co. KG | PQH | Class II | 2016-12-21 |
| K160574 | K3PRO SURGICAL TRAY | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | KCT | Class II | 2016-12-20 |
| K160007 | Paclitaxel Sets | Baxter Healthcare Corporation | FPA | Class II | 2016-12-19 |
| K162081 | 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 | Becton, Dickinson and Company | FMF | Class II | 2016-12-19 |
| K161390 | Vinyl Exam Gloves, Powder Free, Clear | Zibo Hongchin Plastic and Rubber Co., Ltd. | LYZ | Class I | 2016-12-19 |
| K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring System | Iradimed Corporation | FRN | Class II | 2016-12-15 |
| K162900 | PowerMidline Catheter | C.R. Bard, Inc. | PND | Class II | 2016-12-14 |
| K160306 | Cloud Smart Thermometer | Guangzhou Bosma Technology Co, Ltd. | FLL | Class II | 2016-12-13 |
| K160745 | neoBLUE compact LED Phototherapy System | Natus Medical Incorporated | LBI | Class II | 2016-12-12 |
| K162516 | BD Pen Needle | Becton, Dickinson and Company | FMI | Class II | 2016-12-09 |
| K162600 | Jewel Precision Reusable Rigid Sterilization Container System | Jewel Precision Sheet Metal & Machine, Inc. | KCT | Class II | 2016-12-09 |
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets | Quest Medical, Inc. | FPA | Class II | 2016-12-06 |
| K161800 | OnSite-IV | Pharmc, LLC | LHI | Class II | 2016-12-06 |
| K160492 | Hospira Sapphire Sets | Hospira, Inc. | MRZ | Class II | 2016-12-06 |
| K161728 | Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 | Microfile Intellectual Property GmbH | FLL | Class II | 2016-12-05 |
| K161906 | SCIg60 Infuser | Emed Technologies Corporation | PKP | Class II | 2016-12-01 |
| K161323 | Solution Set for Epidural Use | Baxter Healthcare Corporation | FPA | Class II | 2016-11-30 |
| K161932 | Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink | Terang Nusa Sdn Bhd | LZA | Class I | 2016-11-28 |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | Welldoc, Inc. | MRZ | Class II | 2016-11-22 |
| K161944 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | Shandong Baisheng Medical Products Co., Ltd. | LZA | Class I | 2016-11-21 |
| K162175 | Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less | Vietglove Corporation | LYY | Class I | 2016-11-21 |
| K160595 | PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator | Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti | FRG | Class II | 2016-11-18 |
| K161735 | Non-contact Forehead Thermometer | Shenzhen Dongdixin Technology Co., Ltd. | FLL | Class II | 2016-11-17 |
| K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | Shen Wei (Usa), Inc. | LZA | Class I | 2016-11-17 |
15,723 clearances in the General Hospital panel. Data: openFDA.