Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 36
- Latest Decision
- 2015-05-15
Clearances · page 28 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | FOZ | Class II | 2015-05-15 |
| K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | PKP | Class II | 2015-05-14 |
| K150224 | BLUE VINYL GLOVES POWDER FREE | Zibo Sanying Trade Co., Ltd. | LYZ | Class I | 2015-05-12 |
| K150333 | MedSource Sharps Dart | Medsource International, LLC | MMK | Class II | 2015-05-08 |
| K143147 | Gemini Bonded Sterilization Wrap | Medline Industries, Inc. | FRG | Class II | 2015-05-07 |
| K141146 | INVISIPORT | Stealth Therapeutics, Incorporated | LJT | Class II | 2015-05-01 |
| K150243 | Invictus Medical GelShield | Invictus Medical, Inc. | FMP | Class I | 2015-05-01 |
| K150059 | BD FlowSmart Set | Becton, Dickinson Company | FPA | Class II | 2015-04-28 |
| K143238 | C3 Wave | Medcomp ( Medical Components) | LJS | Class II | 2015-04-24 |
| K150103 | Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs | Hartalega Sdn Bhd | LZA | Class I | 2015-04-23 |
| K142535 | ConMed Mixing and Delivery Kit | Conmed Corporation | FMF | Class II | 2015-04-23 |
| K150110 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2015-04-23 |
| K150860 | Nitroglycerin Sets with DUO-VENT Spike | Baxter Healthcare Corporation | FPA | Class II | 2015-04-16 |
| K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | KCT | Class II | 2015-04-15 |
| K143333 | Revital-Ox RESERT Solution Test Strip | STERIS Corporation | JOJ | Class II | 2015-04-14 |
| K142473 | Lubricating Jelly | Sion Biotext Medical , Ltd. | KMJ | Class I | 2015-04-13 |
| K142911 | ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Huailai ZM Plastic Products Co., Ltd. | LYZ | Class I | 2015-04-10 |
| K141349 | Disposable sterile needle retractable safety syringe | Guangdong Haiou Medical Apparatus Stock Co., Ltd. | MEG | Class II | 2015-04-10 |
| K143610 | BD INTIMA II CLOSED IV CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2015-04-09 |
| K143053 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | FRG | Class II | 2015-04-03 |
| K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | MLR | Class II | 2015-04-03 |
| K141826 | FLASHPAK STERILIZATION CONTAINER SYSTEM | Symmetry Medical Inc- Manchester | FRG | Class II | 2015-04-02 |
| K150263 | K-Pack II Needle-21G x 2 | Terumo Europe N.V. | FMI | Class II | 2015-04-01 |
| K150527 | Xcela Power Injectable PICC | Navilyst Medical, Inc. | LJS | Class II | 2015-03-31 |
| K142892 | Powder-free Clear Vinyl Patient Examination Gloves | Shenyi (Shandong) Plastic Products Co., Ltd. | LYZ | Class I | 2015-03-25 |
| K142332 | BT-400 | Bio-Med USA | LBI | Class II | 2015-03-20 |
| K150448 | NMI PICC III and NMI PICC IV | Navilyst Medical, Inc. | LJS | Class II | 2015-03-19 |
| K141042 | MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES | Mercator Medical (Thailand), Ltd. | LYY | Class I | 2015-03-19 |
| K142801 | Triton Canister System | Gauss Surgical, Inc., | PBZ | Class II | 2015-03-12 |
| K133838 | STERILIZATION POUCH/ROLL MADE WITH TYVEK | Sigma Medical Supplies Corp. | FRG | Class II | 2015-03-11 |
| K142782 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | FRG | Class II | 2015-03-09 |
| K143419 | Patient Examination Gloves | Hartalega NGC Sdn. Bhd. | LYY | Class I | 2015-03-06 |
| K143087 | Hospira Blood Set | Hospira, Inc. | FPA | Class II | 2015-03-04 |
| K150174 | EMMA | Inrange Systems, Inc. | NZH | Class II | 2015-02-26 |
| K143015 | Hospira Primary Sets | Hospira, Inc. | FPA | Class II | 2015-02-25 |
| K142937 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | KCT | Class II | 2015-02-24 |
| K142435 | 3S Safety Syringe with/without Needle | Sincere Medical Device Co., Ltd. | MEG | Class II | 2015-02-20 |
| K142436 | 3S Safety Insulin Syringe | Sincere Medical Device Co., Ltd. | MEG | Class II | 2015-02-19 |
| K141285 | BUSSE EXTENSION SET | Busse Hospital Disposables | FPA | Class II | 2015-02-19 |
| K142374 | ivWatch Model 400 | Ivwatch, LLC | MRZ | Class II | 2015-02-13 |
| K143131 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | Kossan International Sdn Bhd | LZA | Class I | 2015-02-12 |
| K143055 | Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla | Yty Industry (Manjung) Sdn Bhd | LZA | Class I | 2015-02-12 |
| K142685 | NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE | Siam Sempermed Corp., Ltd. | LZA | Class I | 2015-02-11 |
| K142858 | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) | Careplus (M) Sdn Bhd | LZA | Class I | 2015-02-09 |
| K140949 | ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE | Ultimed Incorporated | MEG | Class II | 2015-02-09 |
| K141982 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Wrp Asia Pacific Sdn. Bhd. | LZC | Class I | 2015-02-05 |
| K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | LJS | Class II | 2015-01-27 |
| K141634 | NAUTILUS DELTA | Romedex International Srl | LJS | Class II | 2015-01-27 |
| K141448 | TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | Teva Medical Ltd., Migada Plant | ONB | Class II | 2015-01-23 |
| K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) | Central Medicare Sdn Bhd | LZA | Class I | 2015-01-22 |
| K140736 | STERISAFE HP TABLE-TOP STEAM STERILIZER | Milton E Pedrazzi D.D.S., Inc. | FLE | Class II | 2015-01-20 |
| K142109 | STERILUCENT STERILIZATION CONTAINER SYSTEM | Sterilucent, Inc. | KCT | Class II | 2015-01-20 |
| K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) | Yty Industry (Manjung) Sdn Bhd | LZA | Class I | 2015-01-16 |
| K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | Hospira, Inc. | FRN | Class II | 2015-01-16 |
| K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | Careplus (M) Sdn Bhd | LZA | Class I | 2015-01-16 |
| K142590 | All Safe Huber Safety Infusion Set | Nexus Medical, LLC | FPA | Class II | 2015-01-16 |
| K142703 | Powder-free PVC Vinyl Exam Gloves | Hebei Grandeast Plastic Products Co., Ltd. | LYZ | Class I | 2015-01-15 |
| K142622 | IV Administration | Hospira, Inc. | FPA | Class II | 2015-01-15 |
| K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | FLE | Class II | 2015-01-15 |
| K141224 | JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES | Shijiazhunag Jiuyuan Plastic Co., Ltd. | LYZ | Class I | 2015-01-15 |
| K142974 | Extension Sets | Hospira, Inc. | FPA | Class II | 2015-01-09 |
| K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | LZG | Class II | 2015-01-09 |
| K142034 | 3M STERI-VAC STERILIZER/AERATOR | 3M Company | FLF | Class II | 2015-01-08 |
| K143757 | ANUTRA Feedback Aspiration Syringe | Anutra Medical, Inc. | FMF | Class II | 2015-01-08 |
| K142529 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | KCT | Class II | 2015-01-08 |
| K142136 | ACCUCATH MIDLINE CATHETER SYSTEM | Vascular Pathways, Inc. | FOZ | Class II | 2015-01-08 |
| K141878 | HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES | Tangshan Hongyun Plastic Products Co., Ltd. | LYZ | Class I | 2014-12-24 |
| K141479 | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | Covidien | LZH | Class II | 2014-12-23 |
| K142630 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | KCT | Class II | 2014-12-23 |
| K142771 | Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Xuanhua Metallurgical Industry Co., Ltd. | LYZ | Class I | 2014-12-22 |
| K133800 | ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI | Hgi Industires | FRA | Class II | 2014-12-19 |
| K142508 | Powder Free Yellow Vinyl Patient Examination Gloves | Zibo Huaqi Trading Co., Ltd. | LYZ | Class I | 2014-12-19 |
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | Advanced Sterilization Products | FRG | Class II | 2014-12-19 |
| K142333 | SMART LABEL, PROPOFOL | American I.V. Products, Inc. Dba Aiv, Inc. | MRZ | Class II | 2014-12-18 |
| K141474 | BECTON DICKINSON INTELLIPORT SYSTEM | Becton, Dickinson & CO | PHC | Class II | 2014-12-18 |
| K142619 | Snap Insulin Pump System | Asante Solutions, Inc. | LZG | Class II | 2014-12-18 |
| K142805 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) | Hartalega Sdb. Bhd. | LZA | Class I | 2014-12-18 |
| K141712 | KIMGUARD ONE STEP STERILIZATION WRAP | Halyard Health | FRG | Class II | 2014-12-18 |
| K142570 | Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) | Ever Light Plastic Products Co., Ltd. | LYZ | Class I | 2014-12-18 |
| K142342 | NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Nacrous Plastic Co., Ltd. | LYZ | Class I | 2014-12-18 |
| K142588 | Nitrile Powder Free Examination Glove (Blue) | Hartalega Sdn Bhd | LZA | Class I | 2014-12-18 |
| K141698 | STERIZONE CHEMICAL INDICATOR | Tso3, Inc. | JOJ | Class II | 2014-12-17 |
| K143488 | InFill Graft Delivery System | Pinnacle Spine Group, LLC | FMF | Class II | 2014-12-17 |
| K142571 | Powder Free Vinyl Patient Examination Gloves | Ever Light Plastic Products Co., Ltd. | LYZ | Class I | 2014-12-17 |
| K141163 | STERIZONE STERILIZER | Tso3, Inc. | PJJ | Class II | 2014-12-17 |
| K141580 | STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR | Tso3, Inc. | FRC | Class II | 2014-12-17 |
| K141009 | FORT DEFIANCE AUTOMATED STEAM STERILIZER | Fort Defiance Industries, Inc. | FLE | Class II | 2014-12-16 |
| K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Summit Medical, Inc. | KCT | Class II | 2014-12-15 |
| K141303 | ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR | Zhida Glove Co., Ltd. | LZA | Class I | 2014-12-12 |
| K142620 | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe | Excelsior Medical Corporation | NGT | Class II | 2014-12-12 |
| K141304 | YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR | Yongxin Healthcare Co., Ltd. | LZA | Class I | 2014-12-12 |
| K141389 | SAPPHIRE INFUSION PUMP | Q Core Medical , Ltd. | FRN | Class II | 2014-12-11 |
| K142661 | Bi-Portal Bone Graft Delivery Device | Spinal Surgical Strategies, LLC | FMF | Class II | 2014-12-11 |
| K142343 | Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) | Tangshan Hongyun Plastic Products Co., Ltd. | LYZ | Class I | 2014-12-10 |
| K142433 | Hospira Extension Set | Hospira, Inc. | FPA | Class II | 2014-12-08 |
| K143205 | Viscoelastic Injector | Sight Sciences, Inc. | MRH | Class II | 2014-12-05 |
| K140838 | IV ADMINISTRATION SET WITH HAND PUMP | B.Braun Medical, Inc. | FPA | Class II | 2014-12-05 |
| K142409 | Vinyl Co-Polymer Powder Free Examination Gloves | Grand Work Plastic Products Co., Ltd. | LYZ | Class I | 2014-12-05 |
| K141613 | GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES | Zibo Goldenline Plastic Product Co., Ltd. | LYZ | Class I | 2014-12-04 |
| K140657 | CUROS RED PORT PROTECTOR | Ivera Medical, Inc. | QBP | Class II | 2014-12-04 |
15,723 clearances in the General Hospital panel. Data: openFDA.