meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
30
Latest Decision
2011-03-15

Clearances · page 38 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K103409 ALLERGEAZE R CLEAR Smartpractice KXF Class I 2011-03-15
K102563 SINGLE CANNULA EXTENDED APPLICATOR Micromedics, Inc. KYZ Class I 2011-03-15
K103053 VERIFY 270FP CHALLENGE PACK STERIS Corporation JOJ Class II 2011-03-10
K092622 STERRAD 100NX STERILIZER EXPRESS CYCLE Advanced Sterilization Products MLR Class II 2011-03-04
K102554 AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES Avita Corporation FLL Class II 2011-03-03
K101820 NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES Yty Industry (Manjung) Sdn Bhd LZA Class I 2011-03-03
K103126 TROPHON CHEMICAL INDICATOR Nanosonics Limited JOJ Class II 2011-03-03
K110456 PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM Pharmajet, Inc. KZE Class II 2011-03-02
K102947 NON-CONTACT INFRARED THERMOMETER K-Jump Health Co., Ltd. FLL Class II 2011-02-25
K092755 STERRAAD 100NX EXPRESS CYCLE TEST PACK Advanced Sterilization Products FRC Class II 2011-02-25
K103222 STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products FRC Class II 2011-02-25
K103772 VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE) Advanced Medical Devices Factory LYZ Class I 2011-02-25
K103337 MULTIPLE NAME Ideal Quality Sdn., Bhd. LZA Class I 2011-02-25
K101708 PATIENT SAFE LUER CAP Retractable Technologies, Inc. FMF Class II 2011-02-24
K103825 V-GO INSULIN DELIVERY SYSTEM Valeritas, Inc. LZG Class II 2011-02-23
K102192 INDISCAL DIGITAL MANOMETER Baylis Medical Co., Inc. FMF Class II 2011-02-23
K102840 PATIENT EXAMINATION GLOES Thai Hua Holding Co., Ltd. LYY Class I 2011-02-18
K101838 VTS1000 Vuetek Scientific, LLC KZA Class I 2011-02-18
K103226 STERILIZATION MATS STERIS Corporation KCT Class II 2011-02-18
K101233 SAFE'N'SOUND PASSIVE DELIVERY SYSTEM Rexam Pharma MEG Class II 2011-02-18
K103321 DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES Dana Products, Inc. FRC Class II 2011-02-16
K103000 SMART READ BIOLOGICAL TEST PACK Steritec Products Mfg Co, Inc. JOJ Class II 2011-02-11
K101270 SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 Excelsior Medical Corp. NGT Class II 2011-02-10
K102296 VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2) STERIS Corporation JOJ Class II 2011-02-09
K103781 MED-LOK SAFETY NEEDLE Sta-Med, LLC MEG Class II 2011-02-08
K102838 PATIENT EXAMINATION GLOVES Thai Hua Holding Co., Ltd. LYY Class I 2011-02-03
K103011 ULTICARE SAFETY INSULIN SYRINGE Ulti-Med Intl., Inc. MEG Class II 2011-02-02
K103213 FINESS ENDOSCOPE STERILIZATION TRAY Entellus Medical, Inc. KCT Class II 2011-02-02
K102884 STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR Advanced Sterilization Products FRC Class II 2011-01-28
K102363 SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004 Spsmedical Supply Corp. JOJ Class II 2011-01-27
K103800 BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS Kaz USA, Inc (A Subsidiaryof Kaz Inc) FLL Class II 2011-01-26
K102227 INFA WARMER I Atom Medical Corporation FMT Class II 2011-01-21
K102584 IMC HYPODERMIC NEEDLE International Medsurg Connection FMI Class II 2011-01-14
K102934 INFRARED EAR THERMOMETER, MODEL IR-04MT Vega Technologies, Inc. FLL Class II 2011-01-14
K102385 NORFOLK MEDICAL NORPORT FAMILY OF PORTS Norfolk Medical Products, Inc. LJT Class II 2011-01-14
K102864 84E SERIES SINGLE PLY WRAPPER Lac Mac, Ltd. FRG Class II 2011-01-14
K100891 DANA EMULATING INDICATOR Dana Products, Inc. JOJ Class II 2011-01-13
K102613 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Hebei Favor Plastic Co., Ltd. LYZ Class I 2011-01-13
K102590 FLEBOSET DOUBLE Laboratorios Grifols, S.A. LHI Class II 2011-01-13
K101614 HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 Dm Systems, Incorporated DWL Class II 2011-01-13
K102508 YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 Yu Long Sheng Technology Co., Ltd. FLL Class II 2011-01-10
K103224 HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING Hospira, Inc. FPA Class II 2011-01-07
K102520 BD NEXIVA CLOSED IV CATHETER SYSTEM Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 2011-01-06
K102544 SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY Smith & Nephew Inc., Endoscopy Div. KCT Class II 2011-01-05
K102226 DUAL INCU I Atom Medical Corporation FMZ Class II 2011-01-04
K102279 INCU I Atom Medical Corporation FMZ Class II 2010-12-29
K103097 INFRARED EAR THERMOMETER Radiant Innovation, Inc. FLL Class II 2010-12-29
K102819 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Hebei Hongtai Plastic Products Co., Ltd. LYZ Class I 2010-12-23
K101522 ULTRA SEAL STERILE LUBRICATING JELLY Ultra Seal Corporation KMJ Class I 2010-12-23
K102817 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Hebei Hongtai Plastic Products Co., Ltd. LYZ Class I 2010-12-23
K102783 HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS Hinson and Hale Medical Technologies, Inc. FRG Class II 2010-12-22
K102710 NEO-SERVO I Atom Medical Corporation FMZ Class II 2010-12-22
K102966 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC Medcomp LJS Class II 2010-12-21
K102761 DANA REUSABLE TEST PACK FOR STEAM STERILIZATION Dana Products, Inc. JOJ Class II 2010-12-20
K102724 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Yuqun New Material Science and Technology CO LYZ Class I 2010-12-20
K102593 SYNTHETIC, POWDER-FREE NITRILE EXAMINATION Zibo Yinghao Medical Products Co., Ltd. LYZ Class I 2010-12-20
K102969 IMC PISTON SYRINGES International Medsurg Connection FMF Class II 2010-12-20
K103198 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Youngshengplastic Co., Ltd. LYZ Class I 2010-12-20
K101870 SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE Sunmax Vietnam Co., Ltd. LZA Class I 2010-12-20
K102977 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Heze Juxinyuan Food Co., Ltd. LYZ Class I 2010-12-20
K100576 HIGH PRESSURE SETS-400 PSI Icu Medical, Inc. FPA Class II 2010-12-17
K103249 NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM Cardinal Health, Inc. LZA Class I 2010-12-16
K103536 IBED WIRELESS WITH IBED AWARENESS Stryker Corporation FNL Class II 2010-12-16
K102976 POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED) Heze Juxinyuan Food Co., Ltd. LYZ Class I 2010-12-13
K102718 DIGITAL THERMOMETER; DIGITAL THERMOMETER International Regulatory Consultants, LLC (Irc) FLL Class II 2010-12-13
K102187 RII INFRARED EAR THERMOMETER, Radiant Innovation, Inc. FLL Class II 2010-12-10
K103344 INFUSION SETS Hospira, Inc. FPA Class II 2010-12-10
K101910 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS 3M Company FRC Class II 2010-12-08
K101806 AIDERA DIASEND SYSTEM Aidera AB MRZ Class II 2010-12-07
K102103 SKELETAL DYNAMICS STERILIZATION TRAYS Skeletal Dynamics, LLC KCT Class II 2010-12-07
K101224 SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS Griffiths and Nielsen, Ltd. DWL Class II 2010-12-03
K100504 V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 Valeritas, LLC LZG Class II 2010-12-01
K102790 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG Perusahaan Getah Asas Sdn. Bhd. LZC Class I 2010-11-29
K102108 CLICKFINE PEN NEEDLE Ypsomed AG FMI Class II 2010-11-23
K102444 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Yingbo Medical Products, Inc. LYZ Class I 2010-11-22
K102620 POWDERFREE BLACK NITRILE EXAMINATION GLOVES Pt. Medisafe Technologies LZA Class I 2010-11-22
K102217 SYSTEM 1E CHEMICAL INDICATOR STERIS Corporation JOJ Class II 2010-11-22
K102122 SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 Smith & Nephew, Inc. KCT Class II 2010-11-22
K101547 HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) Henke-Sass, Wolf GmbH FMF Class II 2010-11-22
K102880 BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) Brightway Holdings Sdn. Bhd. LZA Class I 2010-11-19
K101822 NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS Sgmp Co., Ltd. LZC Class I 2010-11-19
K101940 EQUASHIELD SYSTEM PROTECTIVE PLUS Equashield Medical , Ltd. LHI Class II 2010-11-19
K102010 VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET Medpro Safety Products, Inc. FMI Class II 2010-11-19
K092745 VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU STERIS Corporation KCT Class II 2010-11-19
K100720 K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING Kawasumi Laboratories, Inc. FPA Class II 2010-11-18
K102146 BAHADIR STERILIZATION TRAYS Bahadir USA Corp. KCT Class II 2010-11-18
K101368 D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES Dragon Heart Medical, Inc. FPA Class II 2010-11-18
K101244 SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE Truer Medical, Inc. FLL Class II 2010-11-18
K102159 POWERPICC SV CATHETERS C.R. Bard, Inc. LJS Class II 2010-11-17
K101436 PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) Shen Wei (Usa), Inc. LZC Class I 2010-11-17
K102097 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Great Vision Plastic Products Co., LT LYZ Class I 2010-11-17
K102171 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Wuxi Bingfa Gainlite Gloves Cp., Ltd. LYZ Class I 2010-11-16
K102558 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) Tangshan Hengda Plastic Products Co., Ltd. LYZ Class I 2010-11-12
K101106 POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 Best Putra Gloves Sdn Bhd LYY Class I 2010-11-10
K101105 POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 Best Putra Gloves Sdn Bhd LYY Class I 2010-11-10
K101912 THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 Hubdic Co., Ltd. FLL Class II 2010-11-10
K103165 BLOOD SAMPLING SET Acacia, Inc. FPA Class II 2010-11-10
K102073 MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS Benlan, Inc. FPA Class II 2010-11-08
K101943 SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES Tangshan Jiteng Plastic Products Co., Ltd. LZA Class I 2010-11-08
K102337 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE Curon Scientific Co., Ltd. LYZ Class I 2010-11-08

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