Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 33
- Latest Decision
- 2019-09-06
Clearances · page 19 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K182751 | Reusable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | FLL | Class II | 2019-09-06 |
| K191531 | Sure-Fine Insulin Syringes | Shina Med Corporation | FMF | Class II | 2019-09-06 |
| K190899 | bili-hut | Little Sparrows Technologies, Inc. | LBI | Class II | 2019-09-05 |
| K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label | STERIS Corporation | JOJ | Class II | 2019-09-05 |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | STERIS Corporation | MED | Class II | 2019-09-05 |
| K191004 | Advocate Non-Contact Infrared Thermometer | Broadmaster Biotech, Corp. | FLL | Class II | 2019-09-05 |
| K191853 | Dual-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2019-09-05 |
| K182765 | 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe | Top Corporation | FMF | Class II | 2019-09-03 |
| K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate | Nobel Biocare AB | KCT | Class II | 2019-08-29 |
| K182382 | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink | Gmp Medicare Sdn Bhd (F25) | LZC | Class I | 2019-08-29 |
| K183356 | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | Weihai Xingtai Packaging Products Co., Ltd. | FRG | Class II | 2019-08-19 |
| K190328 | HCT Empty EVA Container Pack | Health Care Technologies | KPE | Class II | 2019-08-15 |
| K191143 | PowerFlow Implantable Apheresis IV Port | C.R. Bard, Inc. | PTD | Class II | 2019-08-02 |
| K191741 | Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape | Intertape Polymer, Inc. | JOJ | Class II | 2019-08-02 |
| K182089 | Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs | Platinum Glove Industries Sdn. Bhd. | LZA | Class I | 2019-07-30 |
| K190996 | Bonus Therapeutics Mixing and Delivery System | Bonus Therapeutics , Ltd. | FMF | Class II | 2019-07-28 |
| K183280 | PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs | Smart Glove Corporation Sdn. Bhd. | LZA | Class I | 2019-07-26 |
| K190873 | Infrared Ear/Forehead Thermometer | Joytech Healthcare Co. , Ltd. | FLL | Class II | 2019-07-26 |
| K190062 | STATCLAVE G4 Chamber Autoclave | Scican , Ltd. | FLE | Class II | 2019-07-26 |
| K191092 | Powder-Free Vinyl Patient Examination Gloves, Yellow Color | Anhui Intco Medical Products Co., Ltd. | LYZ | Class I | 2019-07-22 |
| K190260 | STERIZONE(R) VP4 Sterilizer | Tso3, Inc. | PJJ | Class II | 2019-07-19 |
| K190427 | Immucise | Terumo Corporation | FMF | Class II | 2019-07-18 |
| K183663 | Microlife Digital Infrared Ear Thermometer | Microlife Intellectual Property GmbH | FLL | Class II | 2019-07-16 |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | NGT | Class II | 2019-07-12 |
| K181957 | Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted | Tianchang Jiarui Packaging Material Co., Ltd. | FRG | Class II | 2019-07-09 |
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | Interrad Medical, Inc. | KMK | Class I | 2019-07-09 |
| K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | Tuttnauer , Ltd. | FLE | Class II | 2019-07-08 |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard, Inc. | LJT | Class II | 2019-07-08 |
| K182414 | Aesculap® SterilContainer(TM) S2 System | Aesculap, Inc. | KCT | Class II | 2019-07-05 |
| K183149 | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | Central Medicare Sdn Bhd | LZC | Class I | 2019-07-04 |
| K182733 | Rochal Bioshield Silicone Film | Rochal Industries, LLC | KMF | Class I | 2019-06-27 |
| K190080 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) | Comfort Rubber Gloves Industries Sdn. Bhd. | LZA | Class I | 2019-06-27 |
| K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | O&M Halyard, Inc. | LZA | Class I | 2019-06-26 |
| K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate | Gx Corporation Sdn Bhd | LZA | Class I | 2019-06-20 |
| K190095 | Powder-Free Clear Vinyl Patient Examination Gloves | Anhui Intco Medical Products Co., Ltd. | LYZ | Class I | 2019-06-20 |
| K182667 | Med-link Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. | FLL | Class II | 2019-06-18 |
| K183431 | Medline Digital Rectal Thermometer Sheath | Medline Industries, Inc. | FLL | Class II | 2019-06-14 |
| K190667 | Sonopet iQ Sterilization Tray | Paragon Medical | KCT | Class II | 2019-06-13 |
| K182656 | JAMBRO Single Core A Sterilization wrap | Jiangsu Zhande Medical Supplies Co., Ltd. | FRG | Class II | 2019-06-11 |
| K183311 | Ivenix Infusion System (IIS) | Ivenix, Inc. | FRN | Class II | 2019-06-07 |
| K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | MMK | Class II | 2019-05-31 |
| K182308 | Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs | Sri Trang Gloves (Thailand) Co., Ltd. | LZA | Class I | 2019-05-30 |
| K180739 | Clearlink System Solution Set | Baxter Healthcare Corporation | FPA | Class II | 2019-05-28 |
| K190606 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | Kossan International Sdn Bhd | LZA | Class I | 2019-05-28 |
| K182575 | Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Jiangxi Jaysun Medcare Co., Ltd. | LYZ | Class I | 2019-05-24 |
| K182235 | OnSite Waste Sharps Container | Bluestone Medical, Inc. | MMK | Class II | 2019-05-20 |
| K182252 | Cook Unimpregnated Central Venous Catheter | Cook Incorporated | FOZ | Class II | 2019-05-17 |
| K190297 | Celerity HP Incubator | STERIS Corporation | FRC | Class II | 2019-05-14 |
| K182612 | Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) | Zibo Yahao Supplies Co., Ltd. | LZA | Class I | 2019-05-10 |
| K181933 | DePuy Synthes Sterilization Container System | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | KCT | Class II | 2019-05-09 |
| K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | STERIS Corporation | MLR | Class II | 2019-05-09 |
| K182865 | Neodent Instruments Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | KCT | Class II | 2019-05-07 |
| K183016 | SteriCap Mini Needle | Ocujet, LLC | FMI | Class II | 2019-05-07 |
| K183701 | Stryker ChestShield Sterilization Tray System | Paragon Medical | KCT | Class II | 2019-05-07 |
| K190159 | Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | Showa Best Glove, Inc. | LZC | Class I | 2019-05-06 |
| K190182 | Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development | FRN | Class II | 2019-05-06 |
| K182437 | Wireless Intelligent Thermometer | Shenzhen Jumper Medical Equipment Co., Ltd. | FLL | Class II | 2019-05-05 |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) | Kawasumi Laboratories, Inc. | FPA | Class II | 2019-05-02 |
| K190305 | Additive Cap | International Medical Industries, Inc. | KPE | Class II | 2019-04-30 |
| K182092 | BD Intelliport System | Becton, Dickinson and Company | PHC | Class II | 2019-04-30 |
| K190489 | Elcam Stopcocks and Manifolds | Elcam Medical Acal | FMG | Class II | 2019-04-23 |
| K182640 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | Shandong Hengya Packaging Printing Co.,Ltd | LZA | Class I | 2019-04-12 |
| K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator | Allergy & Applicator Depot, LLC | SCL | Class II | 2019-04-10 |
| K182770 | Adult Intraosseous Infusion Device | Einstein Works, LLC | FMI | Class II | 2019-04-09 |
| K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Kossan International Sdn Bhd | LZA | Class I | 2019-04-05 |
| K190103 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System | STERIS Corporation | MLR | Class II | 2019-04-05 |
| K182268 | EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) | Flat Medical Co., Ltd. | FMF | Class II | 2019-04-05 |
| K180843 | HIgH-Flo Super26 Subcutaneous Needle Sets | Repro-Med Systems, Inc. Dba Rms Medical Products | FPA | Class II | 2019-04-04 |
| K182597 | Infrared thermometer | Shenzhen Pango Electronic Co., Ltd. | FLL | Class II | 2019-04-03 |
| K190242 | Tyto Thermometer | Tyto Care , Ltd. | FLL | Class II | 2019-03-27 |
| K183410 | AMSCO 600 Steam Sterilizer | STERIS Corporation | FLE | Class II | 2019-03-27 |
| K182897 | Velano Vascular Q2 Extension Set | Velano Vascular | FPA | Class II | 2019-03-26 |
| K181360 | ON-Q* Pump with Bolus | Halyard Health | MEB | Class II | 2019-03-22 |
| K182554 | Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs | He Chuang Plastic & Rubber Co., Ltd. | LZA | Class I | 2019-03-22 |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System | Steris Corporations | MED | Class II | 2019-03-22 |
| K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | Owens & Minor Halyard, Inc. | FRG | Class II | 2019-03-22 |
| K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2019-03-20 |
| K182383 | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | Yty Industry (Manjung) Sdn Bhd | LZC | Class I | 2019-03-19 |
| K180127 | TCAT (R) THA Instrument Tray Set | THINK Surgical, Inc. | KCT | Class II | 2019-03-15 |
| K183187 | nextaro Transfer System, nextaro va | Sfm Medical Devices GmbH | LHI | Class II | 2019-03-15 |
| K182589 | BD Plastipak Syringe | Becton, Dickinson and Company | FMF | Class II | 2019-03-14 |
| DEN170044 | ClearMate | Thornhill Research, Inc. | QFB | Class II | 2019-03-14 |
| K181447 | Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. | FMI | Class II | 2019-03-12 |
| K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs | Sri Trang Gloves (Thailand) Co., Ltd. | LZA | Class I | 2019-03-11 |
| K182870 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | 2019-03-07 |
| K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | Mac Medical, Inc. | LGZ | Class II | 2019-03-05 |
| K183401 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | STERIS Corporation | FRG | Class II | 2019-03-01 |
| K181730 | BD Vacutainer Eclipse UltraFill Blood Collection Needle | Becton, Dickinson and Company | FMI | Class II | 2019-03-01 |
| K181788 | Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corp. | JOJ | Class II | 2019-03-01 |
| K183402 | PRO-LITE Sterilization Tray | STERIS Corporation | KCT | Class II | 2019-03-01 |
| K182629 | Digital Thermometer | Joytech Healthcare Co. , Ltd. | FLL | Class II | 2019-02-28 |
| K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | JOJ | Class II | 2019-02-26 |
| K182052 | Omni Instrument Tray | Hologic, Inc. | KCT | Class II | 2019-02-26 |
| K181870 | Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use | Wuhan W.E.O Science & Technology Development Co., Ltd. | FPA | Class II | 2019-02-26 |
| K182859 | Babyleo TN500 | Dragerwerk AG & CO Kgaa | FMZ | Class II | 2019-02-22 |
| K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP | Valmed S.R.L. | KPE | Class II | 2019-02-15 |
| K183209 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | JOJ | Class II | 2019-02-15 |
| K181508 | U&U Blood Collection Sets | U&U Medical Technology Co, Ltd. | FMI | Class II | 2019-02-13 |
| K183132 | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | O&M Halyard, Inc. | LZC | Class I | 2019-02-05 |
| K183139 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | KCT | Class II | 2019-02-01 |
15,723 clearances in the General Hospital panel. Data: openFDA.