meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
31
Latest Decision
2002-12-13

Clearances · page 60 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K023491 AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM Help Technologies FRN Class II 2002-12-13
K023469 VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062 Victus, Inc. FPA Class II 2002-12-10
K023098 ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT Mckinley Infuser MEB Class II 2002-12-09
K023577 POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G) Yty Industry (Manjung) Sdn Bhd LYY Class I 2002-12-06
K023716 SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP Spsmedical Supply Corp. FRC Class II 2002-12-05
K023108 STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE Atlantic Products, Inc. FMF Class II 2002-12-03
K023517 DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE Wrp Asia Pacific Sdn. Bhd. LZA Class I 2002-12-02
K020837 MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE Shanghai Motex Healthcare Co., Ltd. LYY Class I 2002-12-02
K020533 EXEL VACULET BLOOD COLLECTION SET Exelint Intl. Co. FPA Class II 2002-12-02
K023522 EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR Ever-More Latex Products Sdn Bhd LYY Class I 2002-11-29
K023523 EVER-MORE POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES Ever-More Latex Products Sdn Bhd LYY Class I 2002-11-29
K023524 EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES Ever-More Latex Products Sdn Bhd LYY Class I 2002-11-29
K022057 KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX Kyung GI Medical Ind. Co., Ltd. FMI Class II 2002-11-22
K023585 FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000 Intravascular Incorporated FPA Class II 2002-11-21
K023711 DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE Acute Ideas Co. , Ltd. FLL Class II 2002-11-21
K022671 FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd LZA Class I 2002-11-18
K023747 PHASEAL Carmel Pharma Ab. LHI Class II 2002-11-15
K021565 LUTHER SAFETY HUBER NEEDLE SET Luther Research Partners FPA Class II 2002-11-14
K022784 SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR Syntex Healthcare Products Co., Ltd. LZA Class I 2002-11-13
K023054 JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE Mandala Health Care, LLC MQX Class II 2002-11-13
K023153 MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL Ansell Healthcare Products, Inc. LYY Class I 2002-11-13
K023159 MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE Industrial Clothings, Ltd. LYY Class I 2002-11-12
K022572 NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES Ar Alliance Healthcare Sdn. Bhd. LZA Class I 2002-11-08
K023590 POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES Yty Industry (Manjung) Sdn Bhd LYY Class I 2002-11-08
K023039 BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 Tuta Healthcare Pty Limited BRZ Class II 2002-11-07
K023458 TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML) Taiject Medical Device Co., Ltd. MEG Class II 2002-11-07
K022159 PISTON SYRINGE & HYPODERMIC NEEDLE International Medsurg Connection FMF Class II 2002-11-07
K022645 CURAD Beiersdorf AG KMF Class I 2002-11-05
K023538 TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER Medport, Inc. FLL Class II 2002-11-01
K023323 1CC FUTURA SAFETY SYRINGE Futura Medical Technology MEG Class II 2002-10-29
K023471 DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP Disetronic Medical Systems AG LZG Class II 2002-10-29
K023262 POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS) Perusahaan Getah Asas Sdn. Bhd. LYY Class I 2002-10-28
K023343 ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED Shanghai Palomar Mountain Industries, Inc. LYZ Class I 2002-10-28
K022613 HELIX HYDRO-JET Erbe USA, Inc. FQH Class II 2002-10-25
K022604 POWDER FREE ELASTIC VINYL EXAMINATION GLOVES Sun Flower Gloves Co., Ltd. LYZ Class I 2002-10-25
K023428 VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE Shanghai Jiawang Industrial Co. , Ltd. LZA Class I 2002-10-25
K022706 SPSMEDICAL SPORVIEW STEAM BI TEST PACK Spsmedical Supply Corp. FRC Class II 2002-10-25
K022477 SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET Summit Medical , Ltd. CAK Class II 2002-10-25
K022987 LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM Arista Latindo Industrial Ltd. P.T LYY Class I 2002-10-21
K022346 CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES Latexx Manufacturing Sdn.Bhd. LZA Class I 2002-10-18
K022895 ELCAM STOPCOCKS AND MANIFOLDS Medical Device Consultants, Inc. FMG Class II 2002-10-18
K023318 I-FLOW ELASTOMERIC PUMP WITH BOLUS I-Flow Corp. MEB Class II 2002-10-18
K023069 TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER Medport, Inc. FLL Class II 2002-10-18
K023235 MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE Shandong Jiazhan Plastic Products Co., Ltd. LYZ Class I 2002-10-18
K022756 NIPRO BIO-FLEX CATHETER Nipro Medical Corp. FOZ Class II 2002-10-18
K022016 POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE Top Glove Medical (Thailand) Co., Ltd. LYY Class I 2002-10-15
K022566 POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO Qingdao Bestex Rubber & Plastic Products Co., Ltd. LYY Class I 2002-10-15
K022765 NITRILE POWDER-FREE EXAMINATION GLOVES Allegiance Healthcare Corp. LZA Class I 2002-10-11
K022336 BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD Tangshan Zhonghong Pulin Group Co., Ltd. LYZ Class I 2002-10-11
K023145 VINYL EXAMINATION GLOVES, PRE-POWDERED Shandong Jiazhan Plastic Products Co., Ltd. LYZ Class I 2002-10-11
K022415 BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST Waismed, Ltd. FMI Class II 2002-10-11
K023170 NITRILE POWDER-FREE EXAMINATION GLOVES Allegiance Healthcare Corp. LZA Class I 2002-10-09
K022441 STERRAD SEALSURE CHEMICAL INDICATOR TAPE Advanced Sterilization Products JOJ Class II 2002-10-08
K022781 MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE Industrial Clothings, Ltd. LZA Class I 2002-10-08
K022495 GETTIG DISPOSABLE SYRINGES Gettig Pharmaceutical Instrument Co. FMF Class II 2002-10-08
K022808 DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) Wrp Specialty Products Sdn. Bhd. LYY Class I 2002-10-03
K022904 DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE Wrp Asia Pacific Sdn. Bhd. LZA Class I 2002-10-03
K023088 BONE GRAFT SYRINGE, MODEL 8600-00X0 Wrightmedicaltechnologyinc FMF Class II 2002-10-02
K023062 GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT Abbott Laboratories, Inc. FRN Class II 2002-09-30
K022406 EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET Exelint Intl. Co. FMI Class II 2002-09-30
K022792 CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED) Seal Polymer Industries Bhd. LYY Class I 2002-09-26
K022983 BARDPORT X-PORT ISP PORT C.R. Bard, Inc. LJT Class II 2002-09-25
K020786 INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM Rosch AG Medizintechnic KZE Class II 2002-09-25
K022659 ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) Purna Bina Sdn Bhd LYY Class I 2002-09-25
K022220 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR Shen Wei (Usa), Inc. LYY Class I 2002-09-23
K022869 SOAKER CATHETER I-Flow Corp. FRN Class II 2002-09-20
K022099 SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S Hdc Corp. FOZ Class II 2002-09-20
K022387 CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC Craftmatic Organization, Inc. LLI Class II 2002-09-19
K022806 DUOPRO SAFETY SYRINGE (DUOPROSS) M.K. Meditech Co. , Ltd. MEG Class II 2002-09-19
K022196 NATUS BLUE LIGHT PHOTOTHERAPY UNIT Natus Medical, Inc. LBI Class II 2002-09-19
K013280 STERILOX LIQUID CHEMICAL STERILANT SYSTEM Sterilox Technologies, Inc. MED Class II 2002-09-18
K022818 MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR Smart Glove Corp. Sdn Bhd LZA Class I 2002-09-17
K022878 BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE) Brightway Holdings Sdn. Bhd. LZA Class I 2002-09-17
K022701 POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E Perusahaan Getah Asas Sdn. Bhd. LYY Class I 2002-09-17
K022343 GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS) Pt. Wrp Buana Multicorpora LYY Class I 2002-09-16
K021983 ULTI GUARD HOME INSULIN SYRINGE CONTAINER Ultimed, Inc. MMK Class II 2002-09-16
K022600 POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES Shijiazhuang Wally Plastics Co., Ltd. LYZ Class I 2002-09-16
K022702 POWDERED SYNTHETIC VINYL EXAM GLOVES Shijiazhuang Holy Plastics Co., Ltd. LYZ Class I 2002-09-16
K022639 SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES Shijiazhuang Holy Plastics Co., Ltd. LYZ Class I 2002-09-16
K022278 TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML) Taiject Medical Device Co., Ltd. MEG Class II 2002-09-12
K022110 KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. Kawasumi Laboratories, Inc. LJT Class II 2002-09-12
K022876 MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 International Biomedical, Inc. FPL Class II 2002-09-11
K022831 MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP Disetronic Medical Systems AG LZG Class II 2002-09-11
K022619 POWDER FREE NITRILE EXAMINATION GLOVES Ar Alliance Healthcare Sdn. Bhd. LZA Class I 2002-09-06
K022502 INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 Equidyne Systems, Inc. KZE Class II 2002-09-05
K022431 MEDRAD TRANSFER SET Medrad, Inc. FPK Class II 2002-09-05
K022368 DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E Canopus Medical Supply Co., Ltd. LYZ Class I 2002-09-05
K022088 SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE Syntex Healthcare Products Co., Ltd. LYY Class I 2002-09-03
K022090 SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE Syntex Healthcare Products Co., Ltd. LZA Class I 2002-09-03
K022146 SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE Syntex Healthcare Products Co., Ltd. LYY Class I 2002-09-03
K022092 SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE Syntex Healthcare Products Co., Ltd. LYY Class I 2002-09-03
K022063 SAFEPRO SAFETY SYRINGE Formosa Medical Devices, Inc. MEG Class II 2002-08-29
K022260 FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS Isolation Systems, Inc. LGM Class II 2002-08-29
K021916 HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 Harmac Medical Products, Inc. FPA Class II 2002-08-29
K021080 NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS Cardio Med Supplies, Inc. FPA Class II 2002-08-29
K021988 MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM Medrad, Inc. FRN Class II 2002-08-29
K020785 INTROCAN SAFETY IV CATHETER B.Braun Medical, Inc. FOZ Class II 2002-08-28
K013003 APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER Advanced Sterilization Products FRG Class II 2002-08-28
K022601 POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL) Perusahaan Getah Asas Sdn. Bhd. LYY Class I 2002-08-26
K022530 POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS) Hycare Intl. Co., Ltd. LYY Class I 2002-08-26

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