meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
30
Latest Decision
2016-06-07

Clearances · page 26 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K151250 Smart Set Top Spins, Inc. FPA Class II 2016-06-07
K153388 IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle Guangzhou Improve Medical Instruments Co., Ltd. FMI Class II 2016-06-07
K151239 NMI DUAL PORT II Navilyst Medical, Inc. LJT Class II 2016-06-06
K160668 HumaPen Savvio Eli Lilly and Company, Inc. FMF Class II 2016-06-03
K153280 PowerGlide Pro Midline Catheter C.R. Bard, Inc. FOZ Class II 2016-06-02
K160870 Hospira Administration Sets Hospira, Inc. FPA Class II 2016-06-01
K160485 VERIFY VH2O2 Indicator Tape STERIS Corporation JOJ Class II 2016-06-01
K152458 Gemini Bonded Sterilization Wrap Medline Industries, Inc. FRG Class II 2016-06-01
K152340 NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six North American Rescue, LLC MMK Class II 2016-05-31
K161170 BD Eclipse Hypodermic Needle Becton, Dickinson and Company FMI Class II 2016-05-27
K153149 Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 Sejoy Electronics & Instruments Co., Ltd. FLL Class II 2016-05-27
K160305 neoBLUE® LED Phototherapy System Natus Medical Incorporated LBI Class II 2016-05-27
K152818 Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves Ideal Plastic Co., Ltd. LYZ Class I 2016-05-26
K153359 BardPort®, SlimPort®, and X-Port® Implanted Ports C.R. Bard, Inc. LJT Class II 2016-05-20
K160091 Temperature Probe, Affinity Temperature Probe Medtronic, Inc. FLL Class II 2016-05-20
K153553 SiO2 Coated syringe 3 ml Sio2 Medical Products FMF Class II 2016-05-17
K152630 VERIFY STEAM Integrating Indicator STERIS Corporation JOJ Class II 2016-05-12
K152745 ReNew Sterilization Trays(Catalog #3708 and #3709) Microline Surgical, Inc. KCT Class II 2016-05-12
K152680 TD-1035 Thermometer Taidoc Technology Corporation FLL Class II 2016-05-06
K160503 Vented Vial Adapter Transfer Device - 13mm Medimop Medical Projects, Ltd. LHI Class II 2016-05-04
K151390 Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Maxter Glove Manufacturing Sdn Bhd LZC Class I 2016-05-02
K160252 OmniPod Insulin Management System Insulet Corporation LZG Class II 2016-04-27
K152222 NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs Gmp Medicare Sdn Bhd (F25) LZC Class I 2016-04-21
K143477 Nitrile Patient Examination gloves, Powderfree, Blue color Primus Gloves Pvt Limited LZA Class I 2016-04-14
K152111 Symmetry Surgical Quad-Lock Container System Symmetry Surgical, Inc. KCT Class II 2016-04-14
K150921 Orbit Infusion Set Ypsomed AG FPA Class II 2016-04-12
K143612 LifeCare PCA Infusion System Hospira, Inc. MEA Class II 2016-04-08
K160651 BD FlowSmart Set, MiniMed Pro-Set Becton, Dickinson and Company FPA Class II 2016-04-07
K153293 Extension Set B.Braun Medical, Inc. FPA Class II 2016-04-06
K152479 HG Pro Nitrile Powder Free Examination Gloves Healthy Glove Co., Ltd. LZA Class I 2016-04-04
K151650 SMARTez elastomeric infusion pump Epic Medical Pte. , Ltd. MEB Class II 2016-04-04
K153481 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe Becton, Dickinson and Company NGT Class II 2016-04-04
K153562 Powder Free Blue Nitrile Examination Glove Vietglove Corporation LZA Class I 2016-04-01
K151997 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) Hartalega NGC Sdn. Bhd. LZA Class I 2016-03-31
K153146 Infrared Ear Thermometer Sejoy Electronics & Instruments Co., Ltd. FLL Class II 2016-03-31
K153708 Halyard Black-Orange Powder-Free Nitrile Exam Glove Halyard Health LZA Class I 2016-03-31
K152969 ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY Conmed Corporation KCT Class II 2016-03-31
K152640 Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) Fudakang Industries Co., Ltd. FLL Class II 2016-03-28
K152808 U&U Insulin Syringe with/without Safety Retractable Device U&U Medical Technology Co, Ltd. MEG Class II 2016-03-25
K153392 STERIZONE VP4 Sterilizer Ts03, Inc. PJJ Class II 2016-03-24
K152975 VDT985US Vicks SmartTemp Thermometer Kaz USA, Inc., A Helen of Troy Company FLL Class II 2016-03-23
K151754 Glide-On Vinyl Examination Gloves Medline Industries, Inc. LYZ Class I 2016-03-22
K153510 Powder Free Polychloroprene Examination Glove Green Terang Nusa Sdn Bhd LZA Class I 2016-03-21
K153554 Genesis Low Temperature Reusable Rigid Container System Carefusion 2200, Inc. KCT Class II 2016-03-21
K152705 Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color Jiayuan Medical Products Co., Ltd. LZA Class I 2016-03-17
K152334 Sungshim Insulin Pen Needle Sung Shim Medicare Co., Ltd. FMI Class II 2016-03-17
K152814 Giraffe OmniBed Carestation CS1 Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company FMZ Class II 2016-03-17
K152707 Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color Minghao Medical Products Co., Ltd. LZA Class I 2016-03-17
K153238 Dignity Dual Port Medcomp ( Medical Components) LJT Class II 2016-03-15
K160374 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System Tangent Medical Technologies, Inc. FOZ Class II 2016-03-11
K152394 Rapicide PA High-Level Disinfectant Test Strips Medivators, Inc. JOJ Class II 2016-03-11
K152720 Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color Xingda Medical Products Co., Ltd. LZA Class I 2016-03-10
K152712 Nitrile Powder Free Patient Examination Gloves, Blue Color Zhonghong Pulin Medical Products Co., Ltd. LZA Class I 2016-03-09
K152824 MEDT PEN NEEDLE Shandong Caremed Medical Products Co., Ltd. FMI Class II 2016-03-07
K152402 IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) Securus,Inc FLL Class II 2016-03-04
K151597 Family of Steam Sterilizers B 28 series Cefla S.C. FLE Class II 2016-03-04
K152050 Pencylcap B.Braun Melsungen AG FMI Class II 2016-03-02
K152748 Braun Thermoscan PRO 6000 Ear Thermometer Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) FLL Class II 2016-03-01
K152719 Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves Xinfu Medical Products Co., Ltd. LYZ Class I 2016-03-01
K151482 BCR-30-min BI™ and RBIP-ST30™ Readout Accessory Bcr Diagnostics, Inc. FRC Class II 2016-02-26
K152715 HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR Haining Medical Products Co., Ltd. LZA Class I 2016-02-25
K152593 LATEX EXAMINATION GLOVE POWDER FREE Careplus (M) Sdn Bhd LYY Class I 2016-02-25
K152088 IV-eye Novarix Limited KZA Class I 2016-02-24
K151423 APEX Compounding System Transfer Set B.Braun Medical, Inc. LHI Class II 2016-02-19
K151680 Powder Free Nitrile Patient Examination Gloves, Blue Color Suqian Xingye Glove Co,Ltd LZA Class I 2016-02-12
K153605 ivWatch Model 400 Ivwatch, LLC PMS Class II 2016-02-11
K151311 Safe Block Pen Needle Artsana S.P.A FMI Class II 2016-02-10
K152739 Electronic Thermometer Guangdong Biolight Meditech Co., Ltd. FLL Class II 2016-02-09
K152271 Powder Free Nitrile Patient Examination Gloves, Black color Suqian Xingye Glove Co,Ltd LZA Class I 2016-02-09
K152743 M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) Microline Surgical, Inc. KCT Class II 2016-02-08
K152819 Amecath Peripheral inserted Central Venous Catheter Sets Ameco Medical Industries LJS Class II 2016-02-05
K153028 Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue Zibo Huiying Medical Products, Co. , Ltd. LYZ Class I 2016-02-05
K153487 CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS Arrow International, Inc. (Subsidiary of Teleflex, Inc.) LJS Class II 2016-02-04
K152410 Top Fine Pen Needle Medexel Co.,Ltd FMI Class II 2016-02-02
K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC Arrow International, Inc. (Subsidiary of Teleflex, Inc.) LJS Class II 2016-01-28
K153159 Vinyl patient examination glove, Powder Free Xingyuan Plastic Products Co., Ltd. LYZ Class I 2016-01-26
K151594 Ellipse Supplemental Instrument Trays Ellipse Technologies, Incorporated KCT Class II 2016-01-25
K152241 Medtronic Transportation/Sterilization Cassettes Medtronic Sofamor Danek USA, Inc. KCT Class II 2016-01-20
K151969 Hospira Extension Sets Icu Medical, Inc. FPA Class II 2016-01-19
K152669 PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std FRG Class II 2016-01-15
K152690 DISPOSABLE THERMOMETER PROBE SHEATHS Pinghu Sama Medical Packing Co., Ltd. FLL Class II 2016-01-15
K153025 Turbett Surgical Container Turbett Surgical, LLC FRG Class II 2016-01-14
K151725 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer Advanced Sterilization Products MLR Class II 2016-01-13
K151450 Endoscope Sterilization Tray Intuitive Surgical, Inc. KCT Class II 2016-01-12
K152508 Ageless Health Medical Digital Thermometer Dongguan Ageless Health Industrial Co., Ltd. FLL Class II 2015-12-31
K152809 Giraffe Incubator Carestation CS1 Ohmeda Medical, A Division of Datex-Ohmeda, Inc. FMZ Class II 2015-12-31
K151686 HumanPen Ergo II Eli Lilly and Company, Inc. FMF Class II 2015-12-30
K151255 Navigator Aesthetic Delivery System Carticept Medical, Inc. FRN Class II 2015-12-30
K152951 Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray Paragon Medical, Inc. KCT Class II 2015-12-28
K153158 Solution Administration Sets with 0.2 Micron Filter Baxter Healthcare Corporation FPA Class II 2015-12-28
K152542 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs Riverstone Resources Sdn Bhd LZA Class I 2015-12-24
K150934 Powder Free Vinyl Patient Examination Glove (Non?-Sterile) Lpl (Hui Zhou) Glove LYZ Class I 2015-12-21
K152692 Powder Free Vinyl Patient Examination Gloves (Green) Supermax Plastic Products Co., Ltd. LYZ Class I 2015-12-21
K151445 Cardinal Health Sterilization Wrap Cardinal Health200, LLC FRG Class II 2015-12-21
K152291 Sterisheet Sterilization Wrap Andersen Sterilizers, Inc. FRG Class II 2015-12-17
K153257 BD FlowSmart Set, MiniMed Pro-Set Becton, Dickinson and Company FPA Class II 2015-12-11
K153298 AccuCath Intravascular Catheter C.R. Bard, Inc. FOZ Class II 2015-12-10
K152783 Merit 20 mL Syringe Merit Medical Systems, Inc. FMF Class II 2015-12-07
K153228 NMI Port, NMI Port II Navilyst Medical, Inc. LJT Class II 2015-12-04
K152441 KIRO Set Kiro Robotics S.L. LHI Class II 2015-12-04

15,723 clearances in the General Hospital panel. Data: openFDA.