Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 35
- Latest Decision
- 2018-07-24
Clearances · page 21 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K181686 | CELERITY 20 Steam Biological Indicator | STERIS Corporation | FRC | Class II | 2018-07-24 |
| K171888 | Non-contact infrared body thermometer | Hetaida Technology Co., Ltd. | FLL | Class II | 2018-07-23 |
| K181242 | Braun BNT400 No Touch + Forehead Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | 2018-07-23 |
| K181015 | Braun BFH175 Infrared Forehead Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | 2018-07-18 |
| K172653 | Power Infuser | ZOLL Medical Corporation | FRN | Class II | 2018-07-18 |
| K180915 | Sonicision Reusable Sterilization Tray | Covidien | KCT | Class II | 2018-07-17 |
| K172874 | Infrared Thermometer | Shenzhen Jiacom Technology CO ., Ltd. | FLL | Class II | 2018-07-12 |
| K180314 | Infrared Thermometer | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | FLL | Class II | 2018-07-11 |
| K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G | Owen Mumford, Ltd. | FMI | Class II | 2018-07-11 |
| K173766 | PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs | Shen Wei USA, Inc. | LZC | Class I | 2018-07-08 |
| K161085 | Nitrile Patient Examination Powder Free Glove, Textured, Black | Multisafe Sdn. Bhd. | LZA | Class I | 2018-07-05 |
| K180720 | Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel | Medibio USA, LLC | FMI | Class II | 2018-06-27 |
| K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | Halyard Health | LZC | Class I | 2018-06-27 |
| K173361 | IV Administration Set | B.Braun Medical, Inc. | FPA | Class II | 2018-06-26 |
| K180769 | SecurAcath | Interrad Medical, Inc. | OKC | Class II | 2018-06-26 |
| K173348 | 0.9% Sodium Chloride Injection, USP | Medline Industries, Inc. | NGT | Class II | 2018-06-21 |
| K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | KCT | Class II | 2018-06-21 |
| K172483 | Kopac Sterile Needle | Poonglim Pharmatech, Inc. | FMI | Class II | 2018-06-21 |
| K180560 | Sherlock 3CG+ T ip Confirmation System | C.R. Bard, Inc. | LJS | Class II | 2018-06-18 |
| K172938 | Disposable Sterile Needle | Jiangsu Caina Medical Co.,Ltd | FMI | Class II | 2018-06-14 |
| K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) | Hartalega Sdn Bhd | LZA | Class I | 2018-06-14 |
| K181442 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | OWP | Class II | 2018-06-13 |
| K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories | Case Medical, Inc. | KCT | Class II | 2018-06-13 |
| K180861 | Vinyl Examination Glove (Clear, Non-Colored) | Zhicheng Trading Co., Ltd. | LYZ | Class I | 2018-06-13 |
| K181429 | CELERITY 20 HP Biological Indicator | STERIS Corporation | FRC | Class II | 2018-06-13 |
| K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Riverstone Resources Sdn Bhd | LZA | Class I | 2018-06-12 |
| K180260 | Powder Free Vinyl Patient Examination Gloves (Yellow, White) | Shanxi Hongjin Plastic Technology Co., Ltd. | LYZ | Class I | 2018-06-12 |
| K172831 | Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. | FRN | Class II | 2018-06-12 |
| K180849 | Vinyl Examination Glove (Clear, Non-Colored) | Huifu Trading Co., Ltd. | LYZ | Class I | 2018-06-11 |
| K173803 | Omnican fine | B.Braun Medical, Inc. | FMI | Class II | 2018-06-11 |
| K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | Ever Global (Vietnam) Enterprise Corp | LZA | Class I | 2018-06-11 |
| K172121 | Digital Thermometer | Fudakang Industrial Co., Ltd. | FLL | Class II | 2018-06-07 |
| K173577 | Guarded Luer Connector | International Medical Industries, Inc. | LHI | Class II | 2018-06-07 |
| K173053 | POWDER FREE LATEX EXAMINATION GLOVE | Professional Latex Sdn Bhd | LYY | Class I | 2018-06-06 |
| K180672 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corporation | FRG | Class II | 2018-06-06 |
| K180661 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | FRG | Class II | 2018-06-05 |
| K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | LZG | Class II | 2018-06-01 |
| K172499 | NEOSHIELD | JMS North America Corporation | ONB | Class II | 2018-06-01 |
| K172825 | MN-111 | W&H Sterilization S.R.L. | FLE | Class II | 2018-05-30 |
| K180553 | VERIFY Spore Test Strip for S40 Sterilant | STERIS Corporation | OVY | Class II | 2018-05-29 |
| K172242 | DripAssist Plus | Shift Labs, Inc. | FLN | Class II | 2018-05-25 |
| K172889 | Infrared Thermometer | Shenzhen Pacom Medical Instruments Co., Ltd. | FLL | Class II | 2018-05-25 |
| K173956 | Biowy PlCC Catheter | Biowy Corporation | LJS | Class II | 2018-05-21 |
| K180545 | VACUETTE SAFELINK Holder with male luer lock | Greiner Bio-One Na, Inc. | FMI | Class II | 2018-05-21 |
| K180259 | Sterile Hypodermic Needle for Single Use | Jiangsu Shenli Medical Production Co., Ltd. | FMI | Class II | 2018-05-18 |
| K172894 | Infrared Thermometer | Shenzhen Jiacom Technology CO ., Ltd. | FLL | Class II | 2018-05-17 |
| K172592 | CADD Yellow High Volume Administration Set with NRFit connector | Smiths Medical Asd, Inc. | PWH | Class II | 2018-05-17 |
| K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Comfort Rubber Gloves Industries Sdn. Bhd. | LZC | Class I | 2018-05-15 |
| K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | Myco Medical Supplies, Inc. | FMI | Class II | 2018-05-14 |
| K180385 | Infrared Body Thermometer | Hetaida Technology Co., Ltd. | FLL | Class II | 2018-05-11 |
| K172719 | HealthBeacon HB2 Sharps Bin | Healthbeacon, Ltd. | MMK | Class II | 2018-05-11 |
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | FRN | Class II | 2018-05-11 |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | Osteomed, LLC | KCT | Class II | 2018-05-10 |
| K180937 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | FMF | Class II | 2018-05-10 |
| K172867 | Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange | Gmp Medicare Sdn Bhd (F25) | LZA | Class I | 2018-05-10 |
| K172191 | STERIZONE VP4 Sterilizer | Tso3, Inc. | PJJ | Class II | 2018-05-09 |
| K173913 | MEDRAD® Imaging Bulk Package Transfer Set | Bayer U.S., LLC | PQH | Class II | 2018-05-04 |
| K172864 | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Maxter Glove Manufacturing Sdn Bhd | LZC | Class I | 2018-05-02 |
| K172656 | BiliLux | Draeger Medical Systems, Inc. | LBI | Class II | 2018-05-01 |
| K180696 | Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) | Medline Industries, Inc. | LZA | Class I | 2018-04-30 |
| K180154 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | LGZ | Class II | 2018-04-27 |
| K172923 | Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue | Top Glove Sdn. Bhd. | LZA | Class I | 2018-04-26 |
| K180548 | 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology | C.R. Bard, Inc (Bard Has Joined Bd) | LJS | Class II | 2018-04-26 |
| K173519 | 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader | 3M Company | FRC | Class II | 2018-04-23 |
| K172511 | Hickman TriFusion Catheter | C.R. Bard, Inc. | LJS | Class II | 2018-04-20 |
| K172154 | Isolette 8000 plus | Draeger Medical Sytems, Inc. | FMZ | Class II | 2018-04-19 |
| K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | Greiner Bio-One Na, Inc. | FMI | Class II | 2018-04-19 |
| K172427 | AViTA Radar Thermo NT16 Series IR Thermometer | Avita Corporation | FLL | Class II | 2018-04-19 |
| K173615 | Stryker Universal Select Sterilization Tray System | Paragon Medical | KCT | Class II | 2018-04-18 |
| K180588 | FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device | Teleflex Medical | FMI | Class II | 2018-04-17 |
| K172930 | mCare Powder-free Blue Nitrile Examination Gloves | Mercator Medical (Thailand), Ltd. | LZA | Class I | 2018-04-13 |
| K180567 | C3 Wave System | Medical Components, Inc. (dba MedComp) | LJS | Class II | 2018-04-12 |
| K171713 | Neodent Instrument Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | KCT | Class II | 2018-04-05 |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | Steris Corporations | MED | Class II | 2018-04-04 |
| K171692 | Instrument basket, for EndoEYE | Olympus Winter & Ibe GmbH | KCT | Class II | 2018-04-02 |
| K173029 | Nipro Syringe | Nipro Medical Corporation | FMF | Class II | 2018-03-30 |
| K172496 | SUPERCATH 5 (26G) | Togo Medikit Co., Ltd. | FOZ | Class II | 2018-03-23 |
| K171982 | DROPLET PEN NEEDLE | Htl-Strefa S.A | FMI | Class II | 2018-03-21 |
| K180148 | ATS Thermal Imaging Probe, ATS Patient Interface Unit | Securus Medical Group, Inc. | FLL | Class II | 2018-03-21 |
| K173437 | 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H | 3M Company | FRC | Class II | 2018-03-19 |
| K172266 | Dynarex Three-Way Stopcock | Dynarex Corporation | FMG | Class II | 2018-03-14 |
| K172795 | Infrared Thermometer | Shenzhen Jumper Medical Equipment Co., Ltd. | FLL | Class II | 2018-03-14 |
| K173694 | STERIZONE VP4 Sterilizer | Tso3, Inc. | PJJ | Class II | 2018-03-13 |
| K173078 | Powder-free Clear Vinyl Patient Examination Gloves | Yongsheng Medical Products Co., Ltd. | LYZ | Class I | 2018-03-09 |
| K173481 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | FLE | Class II | 2018-03-09 |
| K173114 | primeMidline Catheters | Pfm Medical, Inc. | PND | Class II | 2018-03-07 |
| K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray | Medscience Science Research Group, Inc. | SCL | Class II | 2018-03-05 |
| K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Central Medicare Sdn Bhd | LZC | Class I | 2018-03-05 |
| K173879 | MiniMed Mio Advance infusion set | Unomedical A/S | FPA | Class II | 2018-03-05 |
| K173256 | System 1 endo Liquid Chemical Sterilant Processing System | STERIS Corporation | MED | Class II | 2018-03-02 |
| K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | JOJ | Class II | 2018-03-02 |
| K171214 | Infrared Thermometer | Shenzhen Brav Electronic Technologies Co., Ltd. | FLL | Class II | 2018-03-02 |
| K170304 | Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers | Astell Scientific Limited | FLE | Class II | 2018-03-02 |
| K173488 | CELERITY 20 HP Challenge Pack | STERIS Corporation | FRC | Class II | 2018-03-01 |
| K173633 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag | STERIS Corporation | FRC | Class II | 2018-02-28 |
| K172899 | Vygon PICCs | Vygon USA | LJS | Class II | 2018-02-26 |
| K173493 | Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 | STERIS Corporation | FLE | Class II | 2018-02-23 |
| K171823 | U&U Indicator tape and strip | U&U Medical Technology Co, Ltd. | JOJ | Class II | 2018-02-22 |
| K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) | Koon Seng Sdn Bhd | LZA | Class I | 2018-02-22 |
| K171994 | Silicone Peripherally Inserted Central Venous Catheter Set/Tray | Cook Incorporated | LJS | Class II | 2018-02-22 |
15,723 clearances in the General Hospital panel. Data: openFDA.