meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
2005-04-18

Clearances · page 53 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050310 BARDPORT TITANIUM PORTS Bard Access Systems, Inc. LJT Class II 2005-04-18
K050122 POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) Smart Glove Corp. Sdn Bhd LZA Class I 2005-04-18
K043328 MICROFLO-SAFE SCALP VEIN SET Dks Loversan Industria Biomedica Spa FPA Class II 2005-04-15
K041495 PENTADEFLUE IV SOLUTION ADMINISTRATION SETS Pentaferte S.P.A FPA Class II 2005-04-15
K043419 P&P SAFETY SYRINGE Medexel Medical Mfg. Co., Ltd. MEG Class II 2005-04-15
K050532 CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA Spi Gloves Sdn. Bhd. LYY Class I 2005-04-14
K050474 VEINNOVATIONS INFILTRATION SYSTEM Veinnovations, LLC FRN Class II 2005-04-14
K050770 MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT Mckinley Medical, LLC MEB Class II 2005-04-14
K050433 ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM Zimmer Orthopaedic Surgical Products FRN Class II 2005-04-13
K050765 LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE N.S. Uni-Gloves Sdn. Bhd. LZA Class I 2005-04-08
K050207 BD POSIFLOW POSITIVE DISPLACEMENT VALVE Becton Dickinson Infusion Therapy Systems, Inc. FPA Class II 2005-04-07
K050598 POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) Smart Glove Corp. Sdn Bhd LZA Class I 2005-04-07
K050664 SPOR-TEST PA BIOLOGICAL INDICATOR KIT Getinge USA, Inc. FRC Class II 2005-04-07
K050505 DEPOTONE Imprint Pharmaceuticals Limited FMI Class II 2005-04-05
K050131 INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE M.K. Meditech Co. , Ltd. MEG Class II 2005-04-05
K050134 ICC INSULIN SAFEPRO SAFETY SYRINGE Formosa Medical Devices, Inc. MEG Class II 2005-04-05
K032959 CIDEX OPA CONCENTRATE Advanced Sterilization Products MED Class II 2005-04-04
K050450 SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES Zibo Blue Intco Plastic & Rubber Products Co., Ltd. LYZ Class I 2005-04-04
K050115 BLOOD HAND PUMP ADMINISTRATION SET Cardinal Health, Alaris Products BRZ Class II 2005-04-01
K043204 SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP Sgarlato Laboratories, Inc. FRN Class II 2005-03-30
K050467 POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN Shen Wei (Usa), Inc. LZA Class I 2005-03-30
K050106 NOVOFINE AUTOCOVER 30G X 8MM Novo Nordisk, Inc. FMI Class II 2005-03-30
K050455 SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES Zibo Blue Intco Plastic & Rubber Products Co., Ltd. LYZ Class I 2005-03-29
K043600 MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C Medtronic Minimed FRN Class II 2005-03-29
K050295 PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES Helio Medical Supplies, Inc. MQX Class II 2005-03-25
K043590 SE INFUSION SYSTEM WITH MMS Cardinal Health, Alaris Products FRN Class II 2005-03-25
K050301 MRIDIUM 3850 MRI PUMP SYSTEM Iradimed Corporation FRN Class II 2005-03-24
K050591 MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS Raven Biological Laboratories, Inc. FRC Class II 2005-03-23
K042887 ACCU-CHEK SPIRIT Disetronic Medical Systems AG LZG Class II 2005-03-18
K050137 TEMPTOUCH DERMAL THERMOMETER Xilas Medical, Inc. FLL Class II 2005-03-18
K050531 POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) Spi Gloves Sdn. Bhd. LZA Class I 2005-03-18
K050527 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL Spi Gloves Sdn. Bhd. LYY Class I 2005-03-18
K050530 POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) Spi Gloves Sdn. Bhd. LZA Class I 2005-03-16
K050529 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER Spi Gloves Sdn. Bhd. LYY Class I 2005-03-16
K050214 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) Hartalega Sdn Bhd LZA Class I 2005-03-16
K043261 HARVEST GRAFT DELIVERY SYRINGE Harvest Technologies, Corp. FMF Class II 2005-03-11
K050215 NITRILE POWDERED EXAMINATION GLOVES (WHITE) Hartalega Sdn Bhd LZA Class I 2005-03-11
K042696 BODYGUARD INFUSION PUMP SYSTEM Caesarea Medical Electronics , Ltd. FRN Class II 2005-03-11
K042952 VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE Zibo Hengchang Plastic & Rubber Products Co., Ltd. LYZ Class I 2005-03-10
K042951 PRE-POWDERED VINYL EXAM GLOVES Zibo Hengchang Plastic & Rubber Products Co., Ltd. LYZ Class I 2005-03-10
K043478 POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE Shijaizhuang Brilliant Ocean Plastic Co., Ltd. LYZ Class I 2005-03-09
K043235 DRAGON HEART I.V. SET Dragon Heart Medical Devices Co., Ltd. FPA Class II 2005-03-08
K042102 YIXIN SAFETY SYRINGE Jiangxi Sanxin (Eversincere) Medical Devices Group MEG Class II 2005-03-08
K043331 DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 Hubdic Co., Ltd. FLL Class II 2005-03-04
K050176 VORTEX EZ VASCULAR ACCESS PORT Rita Medical Systems, Inc. LJT Class II 2005-02-25
K050303 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X. Mesure Technology Co., Ltd. FLL Class II 2005-02-25
K050339 SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE Laboratorios Grifols, S.A. LHI Class II 2005-02-25
K042563 DUREX PLAY WARMER LUBRICANT Ssl Americas, Inc. KMJ Class I 2005-02-23
K031660 FERRIS POLYMEM STERILE BREAST PAD Ferris Mfg. Corp. NTX Class I 2005-02-22
K042500 DUOPROSS SYRINGES Duopross Meditech Corporation FMF Class II 2005-02-22
K043490 PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE Vidacare Corporation FMI Class II 2005-02-18
K033696 PERSONAL INJECTOR Union Medico Aps KZH Class II 2005-02-16
K050230 TURBO TEMP TRIO Cardinal Health, Alaris Products FLL Class II 2005-02-16
K041839 8NONE Medical Solutions, Inc. LGZ Class II 2005-02-15
K043506 ACUPUNCTURE NEEDLES Marknew Products MQX Class II 2005-02-11
K050107 HARVARD 2 SYRINGE PUMP, MODEL 2001-001 Harvard Clinical Technology FRN Class II 2005-02-11
K043277 C&G ACUPUNCTURE NEEDLE Helio Medical Supplies, Inc. MQX Class II 2005-02-08
K050154 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) Zibo Zhuangyuan Plastic & Rubber Co., Ltd. LYZ Class I 2005-02-07
K050155 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) Zibo Zhuangyuan Plastic & Rubber Co., Ltd. LYZ Class I 2005-02-07
K050152 PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE Dipped Products (Thailand), Ltd. LYY Class I 2005-02-07
K043446 EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER Emmebi Srl FOZ Class II 2005-02-04
K043499 POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE Shijaizhuang Brilliant Ocean Plastic Co., Ltd. LYZ Class I 2005-02-04
K043475 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) Shijiazhuang Winful Plastic Co., Ltd. LYZ Class I 2005-02-01
K043014 POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS) Shijiazhuang Tillotson Rubber Products Co., Ltd. LYY Class I 2005-01-28
K042129 F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK Cedic S.R.L. FPA Class II 2005-01-27
K043582 OCEAN CHEST DRAIN Atrium Medical Corp. KDQ Class II 2005-01-21
K042487 PROCEDUR SF SAFETY SYRINGE DEVICE Avanca Medical Devices, Inc. MEG Class II 2005-01-21
K042486 PROCEDUR 10 SYRINGE DEVICE Avanca Medical Devices, Inc. FMF Class II 2005-01-21
K042898 PANTHERA N POWDER FREE BLACK NITRILE GLOVES Glovco (M) Sdn. Bhd. LZA Class I 2005-01-18
K043502 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC C.R. Bard, Inc. LJS Class II 2005-01-14
K043304 Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 Bioject Medical Technologies, Inc. LHI Class II 2005-01-14
K043135 SPSMEDICAL SPORVIEW PA CULTURE SET Spsmedical Supply Corp. MRB Class II 2005-01-13
K042879 NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING Sgmp Co., Ltd. LZA Class I 2005-01-13
K043477 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) Shijiazhuang Winful Plastic Co., Ltd. LYZ Class I 2005-01-07
K043172 TRUGRAFT BGS SYRINGE, MODEL 600-041 Osteobiologics, Inc. FMF Class II 2005-01-07
K042432 PHARMGUARD TOOLBOX, MODEL G6000782 Medex, Inc. FRN Class II 2005-01-04
K042792 IXL-II DIABETES MANAGEMENT SYSTEM Insulet Corporation LZG Class II 2005-01-03
K043397 MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE Becton, Dickinson & CO FMI Class II 2004-12-29
K041652 ACUPUNCTURE NEEDLES C.A.I. Industries Corp. MQX Class II 2004-12-29
K032434 CLINICAL ELECTRONIC THERMOMETER Cotronic Manufacturing FLL Class II 2004-12-27
K042631 EAR THERMOMETER, MODEL WL-320X Innovatech, Inc. FLL Class II 2004-12-22
K043038 BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML Biotop Technology Co., Ltd. MEG Class II 2004-12-22
K030400 NEOSCI MEDICAL ENDOLUMINAL BRUSH Neosci Medical, Inc. LJS Class II 2004-12-22
K042907 NEEDLE INCAPACITATOR (NEEDLE GUARD) Pdmp, Inc. FMI Class II 2004-12-22
K042666 LUTH-ALL SUB-Q NEEDLE SET Luth-All Medical Products, LLC FPA Class II 2004-12-21
K043482 THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 STERIS Corporation JOJ Class II 2004-12-21
K041038 CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER Churchill Medical Systems, Inc. KPE Class II 2004-12-21
K043159 POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE Shijaizhuang Brilliant Ocean Plastic Co., Ltd. LYZ Class I 2004-12-20
K042239 FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE Pt. Mandiri Inti Buana LZA Class I 2004-12-16
K042805 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE Perusahaan Getah Asas Sdn. Bhd. LZC Class I 2004-12-16
K041623 REUSABLE STERILCONTAINER FILTER MODEL #JK090 Aesculap, Inc. FRG Class II 2004-12-13
K042679 IR VIEWER Infrared Imaging Systems, Inc. KZA Class I 2004-12-10
K043299 MEDLEY PCA MODULE, MODEL 8120 Alaris Medical Systems, Inc. MEA Class II 2004-12-10
K042873 ANIMAS MODEL IR1250 INSULIN INFUSION PUMP Animas Corp. LZG Class II 2004-12-10
K042461 KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 Kendall LJS Class II 2004-12-10
K041833 CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER Consolidated Machine Corp. FLE Class II 2004-12-10
K042454 STRYKER CASSETTE PUMP Stryker Endoscopy GCX Class II 2004-12-09
K043110 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 Microlife Intellectual Property GmbH FLL Class II 2004-12-09
K042588 CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 Confluent Surgical,Inc FMF Class II 2004-12-09
K042817 MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) Ansell Healthcare Products, Inc. LZA Class I 2004-12-06

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