meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
29
Latest Decision
2004-03-17

Clearances · page 56 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K040408 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) Shun Thai Rubber Gloves Industry Public Co., Ltd. LYY Class I 2004-03-17
K031142 DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR Shanghai Palomar Mountain Industries, Inc. LYZ Class I 2004-03-17
K034052 BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES Latexx Manufacturing Sdn.Bhd. LZA Class I 2004-03-15
K040353 FLIGHT SOCK Ssl Americas, Inc. DWL Class II 2004-03-11
K032885 VIDAPORT INTRAOSSEOUS INFUSION SYSTEM Vidacare Corporation FMI Class II 2004-03-10
K033496 MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE Industrial Clothings, Ltd. LYY Class I 2004-03-09
K033892 ULTRAFLEX INFUSION SET Disetronic Medical Systems AG FPA Class II 2004-03-09
K040456 FLEBOSET MULTIPLE Laboratorios Grifols, S.A. LHI Class II 2004-03-09
K040446 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT AngioDynamics, Inc. LJS Class II 2004-03-05
K033301 IV ADMINISTRATION AND CONNECT SETS Codan US Corp. FPA Class II 2004-03-04
K031114 PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA Raven Biological Laboratories, Inc. MRB Class II 2004-03-03
K033531 POWDERED LATEX EXAMINATION GLOVES Apl International Incorporated Limited LYY Class I 2004-03-03
K033887 NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES Yty Industry (Manjung) Sdn Bhd LZA Class I 2004-03-02
K032843 NEXIVA CLOSED IV CATHETER SYSTEM Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 2004-02-27
K032274 COOK FIVE LUMEN CENTRAL VENOUS CATHETER Cook, Inc. FOZ Class II 2004-02-26
K033086 NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE Pt. Medisafe Technologies LZA Class I 2004-02-26
K040176 MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES Maxter Glove Manufacturing Sdn Bhd LZA Class I 2004-02-24
K033723 DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES Baoding Guanzhong Glove Co., Ltd. LYZ Class I 2004-02-24
K033820 MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1 Microlife Intellectual Property GmbH FLL Class II 2004-02-23
K032612 IR FOREHEAD THERMOMETER, MODEL HV-T36 Oriental Inspiration, Ltd. FLL Class II 2004-02-19
K033721 VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT Vascular Solutions, Inc. FMF Class II 2004-02-13
K032813 THE ULTRA SYSTEM SP Promedica, Inc. KCT Class II 2004-02-13
K033575 ONE.CLICK NEEDLE B.Braun Medical, Inc. FMI Class II 2004-02-09
K034060 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) Hong Huang Tang Industrial Co., Ltd. LYZ Class I 2004-02-06
K033777 ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES Syntex Healthcare Products Co., Ltd. LZA Class I 2004-02-05
K033538 BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 Sauter AG FLE Class II 2004-02-02
K033590 ERBE HELIX HYDRO-JET Erbe USA, Inc. FQH Class II 2004-01-30
K033500 BD CAREFLOW CENTRAL VENOUS CATHETER Becton, Dickinson & CO FOZ Class II 2004-01-29
K040114 ABBOTT DATA PORT PC, MODEL 12181 Abbott Laboratories FRN Class II 2004-01-29
K033532 ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES Asia Pacific Latex Sdn Bhd LYY Class I 2004-01-28
K032141 SECUMAX BLOOD COLLECTION SYSTEM Tiger Meditech Incorporated FMI Class II 2004-01-28
K033530 ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES Asia Pacific Latex Sdn Bhd LYY Class I 2004-01-28
K033381 DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL Discus Dental, Inc. MED Class II 2004-01-27
K033686 PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM Smiths Medical MD, Inc. LJT Class II 2004-01-23
K033515 HUBERPRO SAFETY HUBER INFUSION SET Command Medical Products FPA Class II 2004-01-22
K033835 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR Mdm Enterprise Corp. LYZ Class I 2004-01-22
K031321 LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 Medlogic Global Limited KMF Class I 2004-01-21
K034019 POLY PER-Q-CATH PICC CATHETERS C.R. Bard, Inc. LJS Class II 2004-01-21
K034020 GROSHONG NXT PICC CATHETERS C.R. Bard, Inc. LJS Class II 2004-01-21
K033409 AMERSHAM HEALTH NEEDLE-GUARD Gettig Pharmaceutical Instrument Co. FMI Class II 2004-01-21
K034031 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE M.K. Meditech Co. , Ltd. MEG Class II 2004-01-21
K033692 POWDERED VINYL EXAMINATION GLOVES Shen Wei (Usa), Inc. LYZ Class I 2004-01-16
K033877 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR One Touch Products Co., Ltd. LYZ Class I 2004-01-16
K033693 POWDER-FREE VINYL EXAMINATION GLOVES Shen Wei (Usa), Inc. LYZ Class I 2004-01-16
K034023 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 Microlife Intellectual Property GmbH FLL Class II 2004-01-15
K034065 MODIFICATION TO X-PORT DUO PORT C.R. Bard, Inc. LJT Class II 2004-01-15
K033853 MODIFICATION TO V-CATH POLY PICC Hdc Corp. FOZ Class II 2004-01-14
K030739 INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE Infusion Dynamics, Inc. FRN Class II 2004-01-14
K033818 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290 Microlife Intellectual Property GmbH FLL Class II 2004-01-08
K033539 DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR Shen Wei (Usa), Inc. LYZ Class I 2004-01-08
K033683 SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR Smart Glove Corp. Sdn Bhd LZA Class I 2004-01-08
K033817 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2 Microlife Intellectual Property GmbH FLL Class II 2004-01-08
K033250 EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR Edwards Lifesciences, LLC FOZ Class II 2003-12-30
K033794 ULTICARE DISPOSABLE SYRINGE 3 ML/CC Ultimed, Inc. FMF Class II 2003-12-30
K033916 GRI-BAG, GRI-BAG AP Laboratorios Grifols, S.A. KPE Class II 2003-12-30
K033478 VACUETTE QUICKSHIELD SAFETY TUBE HOLDER Greiner Bio-One Vacuette North America FMI Class II 2003-12-29
K032417 HEPARIN LOCK FLUSH SYRINGE Am2 Pat, Inc. FOZ Class II 2003-12-23
K033308 VINYL EXAMINATION GLOVES, POWDERED Tangshan Transocean Plastic Products Co., Ltd. LYZ Class I 2003-12-22
K031373 IXL DIABETES MANAGEMENT SYSTEM Insulet Corp. LZG Class II 2003-12-19
K033040 PHOENIX INFANT RADIANT WARMER, MODEL 100NWS International Hospital Supply Co. FMT Class II 2003-12-17
K033682 SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE Laboratorios Grifols, S.A. LHI Class II 2003-12-17
K033229 (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES Bernard Technologies, Inc. LYZ Class I 2003-12-17
K033054 HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP Harvard Clinical Technology MEA Class II 2003-12-16
K033166 KACEY INSULIN SYRINGE Kacey, Inc. FMF Class II 2003-12-12
K033576 LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE Abbott Laboratories FPA Class II 2003-12-04
K032362 UP-GRADE FOREHEAD THERMOMETER Medisim, Ltd. FLL Class II 2003-12-04
K021692 CLC2000 CATHETER PATENCY DEVICE Icu Medical, Inc. FPA Class II 2003-12-04
K033082 9 SECOND DIGITAL THERMOMETER, MODEL BT-S09 Metatech Co., Ltd. FLL Class II 2003-12-03
K031818 FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE Facilai Enterprises , Ltd. MQX Class II 2003-12-03
K031419 GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML Laboratorios Grifols, S.A. KPE Class II 2003-11-24
K033565 LMT NOMAG IC 1,5 Lmt Lammers Medical Technology GmbH FPL Class II 2003-11-21
K023537 NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2) Sgmp Co., Ltd. LYY Class I 2003-11-20
K032907 FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Fuguan Plastic Products Co., Ltd. LYZ Class I 2003-11-20
K032940 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE Brightway Holdings Sdn. Bhd. LYY Class I 2003-11-20
K032938 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER Brightway Holdings Sdn. Bhd. LYY Class I 2003-11-20
K032908 FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Fuguan Plastic Products Co., Ltd. LYZ Class I 2003-11-20
K023452 OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E Canopus Medical Supply Co., Ltd. LYZ Class I 2003-11-20
K031541 PARADIGMPAL, MODEL MMT-7330 Minimed, Inc. LZG Class II 2003-11-18
K033473 MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT Horizon Medical Products, Inc. LJT Class II 2003-11-18
K033350 BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER Becton, Dickinson & CO FPA Class II 2003-11-18
K032670 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR Kingswell International, Inc. LYZ Class I 2003-11-14
K032777 MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE Nipro Medical Corp. FOZ Class II 2003-11-14
K031170 POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS Long First (Xiamen) Co., Ltd. LYZ Class I 2003-11-13
K032934 MPS ACACIA SAFEGUARD HUBER DEVICE Mps Acacia FPA Class II 2003-11-13
K032444 NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY Cardinalhealth LZC Class I 2003-11-13
K032781 BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Blue Sail Plastic & Rubber Products Co., Ltd. LYZ Class I 2003-11-13
K032783 BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES Zibo Blue Sail Plastic & Rubber Products Co., Ltd. LYZ Class I 2003-11-13
K033373 MONOJECT INSULIN SYRINGE Tyco Healthcare FMI Class II 2003-11-13
K031799 MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 Miele, Inc. LDS Class II 2003-11-12
K030583 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE Shen Wei (Usa), Inc. LYY Class I 2003-11-10
K033425 AMBIT INTERMITTENT AMBULATORY INFUSION PUMP Sorenson Medical, Inc. FRN Class II 2003-11-06
K033325 AMBIT CONTINUOUS AMBULATORY INFUSION PUMP Sorenson Medical, Inc. FRN Class II 2003-11-06
K032425 INVISIJECT RESUSABLE AUTO-INJECTOR Biogen KZH Class II 2003-11-05
K030683 NIPRO DISPOSABLE SYRINGES Nipro Medical Corp. FMF Class II 2003-10-31
K032084 POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR Shen Wei (Usa), Inc. LYZ Class I 2003-10-29
K032119 PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS Paragon Medical, Inc. KCT Class II 2003-10-29
K032024 POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Shen Wei (Usa), Inc. LZA Class I 2003-10-29
K032962 AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE Arrow Intl., Inc. FOZ Class II 2003-10-29
K032485 MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313 Medtronic Minimed FPA Class II 2003-10-28
K032484 MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310 Medtronic Minimed FPA Class II 2003-10-28

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