meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
30
Latest Decision
2011-07-21

Clearances · page 37 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K110966 POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED) Ppp Medical and Safety Products Company Limited LYZ Class I 2011-07-21
K110867 STERI-DENT, STERI-SURE Cpac, Inc. FRG Class II 2011-07-20
K111598 POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE Lpl (Hui Zhou) Glove Co., Ltd. LYZ Class I 2011-07-20
K110443 BD INSYTE AUTOGUARD BC Becton, Dickinson & CO FOZ Class II 2011-07-19
K110956 MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR Medivance, Inc. FLL Class II 2011-07-18
K111328 POWDER FREE NITRILE EXAMINATION GLOVES Gx Corporation Sdn Bhd LZA Class I 2011-07-15
K110857 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR Shandong Zhanpeng Medical Products Co., Ltd. LYZ Class I 2011-07-15
K110697 TIGER SYRINGES AND NEEDLES Tiger Medical Products, Ltd. FMF Class II 2011-07-14
K110960 ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE Koon Seng Sdn Bhd LZA Class I 2011-07-14
K111034 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE Am USA NGT Class II 2011-07-14
K111240 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR Xuzhou Full Sun Medical Products , Ltd. LYZ Class I 2011-07-14
K110418 POWDER FREE NITRILE EXAMINATION GLOVES W.A. Rubbermate Co., Ltd. LZA Class I 2011-07-13
K094026 STERI-DENT, STERI-SURE Cpac, Inc. KMH Class II 2011-07-12
K101194 NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 Carticept Medical, Inc. FRN Class II 2011-07-11
K111150 STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR Steritec Products Mfg Co, Inc. FRC Class II 2011-07-08
K111012 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) True Glove Factory LYZ Class I 2011-07-06
K110682 STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS Case Medical, Inc. KCT Class II 2011-07-01
K111133 NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) Ssc Surat Thani LYY Class I 2011-06-24
K111091 MERIT MEDICAL 20 ML SYRINGE Merit Medical Systems, Inc. FMF Class II 2011-06-24
K110826 CUROS PORT PROTECTOR Ivera Medical QBP Class II 2011-06-23
K110500 STAT-MAT MINOR Macpherson Medical, Inc. KCT Class II 2011-06-23
K103562 CENTURION PRESSURE INJECTABLE EXTENSION SET Centurion Medical Products Corporation FPA Class II 2011-06-23
K103061 BIOMATE STERILE ACUPUNCTURE NEEDLE Biomate Medical Devices Technology Co., Ltd. MQX Class II 2011-06-20
K111459 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR Jiangsu Alfa Glove Co., Ltd. LYZ Class I 2011-06-16
K111297 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) Premier Medical Gloves Factory LYZ Class I 2011-06-16
K110297 POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES Comfort Rubber Gloves Industries Sdn. Bhd. LZA Class I 2011-06-15
K111217 ADDITIVE CAP Baxter Healthcare Corp KPE Class II 2011-06-14
K111244 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) Cook, Inc. LJS Class II 2011-06-14
K103736 DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE Dmc Medical, Ltd. FMF Class II 2011-06-10
K110969 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Ppp Medical and Safety Products Company Limited LYZ Class I 2011-06-10
K110248 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR Jiangsu Dongling Plastic & Rubber Co., Ltd. LZA Class I 2011-06-10
K110247 POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR Jiangsu Dongling Plastic & Rubber Co., Ltd. LZA Class I 2011-06-10
K110850 K-PACK II NEEDLE- 27G & 30G THIN WALL Terumo Europe N.V. FMI Class II 2011-06-09
K111016 SAFEPORT MANIFOLD (TM) (OR STOPCOCK) Elcam Medical Acal FPA Class II 2011-06-09
K110527 K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE Terumo Europe N.V. FMI Class II 2011-06-06
K103210 TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS Advanced Sterilization Products FRG Class II 2011-06-06
K102623 BLUE POWDERFREE NITRILE EXAMINATION GLOVE Pt. Medisafe Technologies LZA Class I 2011-06-06
K103839 BEHIND EAR GENTLE TOUCH THERMOMETER Kaz, Inc. FLL Class II 2011-06-06
K110972 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR Ppp Medical and Safety Products Company Limited LYZ Class I 2011-06-06
K110769 AMSCO WARMING CABINET STERIS Corporation LGZ Class II 2011-06-03
K100895 PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) Dipped Products Limited LYY Class I 2011-05-27
K102935 INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A Kingtech Enterprise, Ltd. FLL Class II 2011-05-27
K102894 CLASSIX CHEMICAL STERILIZATION INDICATOR Propper Mfg. Co., Inc. JOJ Class II 2011-05-25
K110155 NITRILE POWDER FREE PATIENT EXAMINATION GLOVES Tangshan Xiangrui Plastic Products Co., Ltd. LZA Class I 2011-05-23
K102970 GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT Gyrus Acmi, Inc. KCT Class II 2011-05-20
K103801 HYPOTHERMX INTRAVENOUS FLUID WARMER Emit Corporation LGZ Class II 2011-05-20
K102512 RMS SUBCUTANEOUS NEEDLE SET Repro-Med Systems, Inc. FPA Class II 2011-05-20
K103589 NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM Natus Medical Incorporated LBI Class II 2011-05-13
K102328 BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA Shandong Weigao Group Medical Polymer Co., Ltd. FMI Class II 2011-05-13
K110146 NITRILE POWDER FREE PATIENT EXAMINATION GLOVES Tangshan Kaiyue Glove Co., Ltd. LZA Class I 2011-05-13
K110771 BD SINGLE USE, HYPODERMIC SYRINGE Becton, Dickinson and Company FMF Class II 2011-05-13
K110102 POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG Preventive Care, Inc. LZA Class I 2011-05-13
K103407 COTRONIC DIGITAL THERMOMETER Cotronic Manufacturing FLL Class II 2011-05-13
K103525 A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX International Biomedical, Ltd. FPL Class II 2011-05-11
K103523 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX International Biomedical, Ltd. FPL Class II 2011-05-11
K110314 STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED) True Glove Factory LYZ Class I 2011-05-10
K100567 PEARL DIABETES MANAGEMENT SYSTEM M2 Group Holdings, Inc. LZG Class II 2011-05-10
K103718 DYNACOR LUBRICATION GEL Medline Industries, Inc. KMJ Class I 2011-05-10
K110369 INDISTRIP GREEN Indilab, Inc. JOJ Class II 2011-05-06
K110253 REUSABLE TEST PACK FOR DANA EMULATING INDICATORS Dana Products, Inc. JOJ Class II 2011-04-29
K103196 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Changda Plastic Product Co., Ltd. LYZ Class I 2011-04-29
K102152 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Hebei Tengda Plastic Co., Ltd. LYZ Class I 2011-04-28
K110105 BD PEN NEEDLE Becton, Dickinson and Company (BD) FMI Class II 2011-04-28
K110282 LIGHTY DD INFUSION SET Medx-Set, Ltd. FPA Class II 2011-04-27
K102151 POWDERED VINYL PATIENT EXAMINATION GLOVES Hebei Tengda Plastic Co., Ltd. LYZ Class I 2011-04-27
K110421 DISPOSABLE INSULIN SYRINGE Wenzhou Wuzhou Import & Export Co., Ltd. FMF Class II 2011-04-26
K110377 PROTECTIVE RESTRAINT Medi-Tech Intl. Corp. FMQ Class I 2011-04-25
K102902 RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR Rubbercare Protection Products Sdn Bhd LYY Class I 2011-04-22
K103817 POSEY BED J. T. Posey Co. OYS Class I 2011-04-22
K103602 EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM Medline Industries, Inc. LYY Class I 2011-04-21
K103770 SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL Syntex Healthcare Products Co., Ltd. LZA Class I 2011-04-21
K110112 CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE Rongshan LI FMF Class II 2011-04-20
K110219 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Wealth on (Jiangsu) Co., Ltd. LYZ Class I 2011-04-19
K103277 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER 3M Company-3M Health Care FRC Class II 2011-04-19
K110338 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Yuechuan Plastic Products Co., Ltd. LYZ Class I 2011-04-19
K103527 AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX International Biomedical, Ltd. FPL Class II 2011-04-15
K110152 SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS Spsmedical Supply Corp. JOJ Class II 2011-04-15
K103524 VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX International Biomedical, Ltd. FPL Class II 2011-04-15
K110921 NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS Cardinal Health, Inc. LZA Class I 2011-04-15
K102085 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shijiazhuang Glory Plastic Co., Ltd. LYZ Class I 2011-04-14
K101412 EVA TPN BAG Valmed S.R.L. KPE Class II 2011-04-13
K103200 PROPEP DELIVERY DEVICE Rhythmlink International, LLC FMF Class II 2011-04-12
K110023 INFUSION ADAPTER C100 Carmel Pharma Ab. LHI Class II 2011-04-12
K103587 DISPOSABLE BLLOD COLLECTION NEEDLE Weihai Hongyu Medical Devices Co., Ltd. FMI Class II 2011-04-06
K103680 MICROLIFE DIGITAL UNDERARM THERMOMETER Microlife Intellectual Property GmbH FLL Class II 2011-04-06
K110262 SHARPS CONTAINER Noble Marketing MMK Class II 2011-04-05
K110185 NITRILE POWDER FREE PATIENT EXAMINATION GLOVES Tangshan Baojie Glove Co., Ltd. LZA Class I 2011-04-04
K103617 DIGITAL FOREHEAD THERMOMETER K-Jump Health Co., Ltd. FLL Class II 2011-04-04
K103219 STERRAD SEALSURE CHEMICAL INDICATOR TAPE Advanced Sterilization Products JOJ Class II 2011-04-01
K103218 STERRAD CHEMICAL INDICATOR STRIP Advanced Sterilization Products JOJ Class II 2011-04-01
K103670 NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) Innovative Gloves Co;, Ltd. LZA Class I 2011-03-31
K103828 BILI-THERAPY SPOT TYPE Atom Medical Corporation LBI Class II 2011-03-29
K103551 INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, Baxter Healthcare Corp FPA Class II 2011-03-25
K101560 MEDLINE RETRACTABLE SAFETY SYRINGE Medline Industries, Inc. MEG Class II 2011-03-25
K103650 NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM Oon Corp. Resources LYY Class I 2011-03-23
K103661 RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE Rubbercare Protection Products Sdn Bhd LZA Class I 2011-03-23
K110224 SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE Weifang Beihai Color Printing Packagging Co., Ltd. LYZ Class I 2011-03-18
K102846 PATIENT EXAMINATION GLOVES Thai Hua Holding Co., Ltd. LZA Class I 2011-03-17
K103504 GETINGE 400HC/500HC SERIES STEAM STERILIZER Getinge Sourcing, LLC FLE Class II 2011-03-16
K103841 BELIMED STEAM STERILIZER MST-V Sauter AG FLE Class II 2011-03-15

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