meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
37
Latest Decision
2006-06-12

Clearances · page 50 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K060668 SAFE TIP SYRINGE Devon Safety Products, Inc. MEG Class II 2006-06-12
K060141 DAI-R Shl Medical, USA KZH Class II 2006-06-12
K060402 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) Brightway Holdings Sdn. Bhd. LZA Class I 2006-06-09
K060858 LATEX POWDERED EXAMINATION GLOVE High Momentum Sdn Bhd LYY Class I 2006-06-08
K060537 EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 Enginivity, LLC LGZ Class II 2006-06-08
K060488 DERMATECH IV HOLDER Dermatech Medical, Inc. FPA Class II 2006-06-08
K060910 POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Jiangsu Everyguard Plastic Products Co., Ltd. LYZ Class I 2006-06-07
K052798 CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C Isovac Products, LLC LGN Class II 2006-06-06
K060389 CONFIDOSE IM AUTO-INJECTOR Pharma-Pen, Inc. KZH Class II 2006-06-06
K060580 K-SHIELD PORT ACCESS INFUSION SET Kawasumi Laboratories, Inc. FPA Class II 2006-06-06
K060002 RITRACT SAFETY SYRINGE Ritract , Ltd. MEG Class II 2006-06-02
K061240 SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES Lucent Medical Systems LJS Class II 2006-06-02
K053305 SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE Pt Mahakarya Inti Buana LYY Class I 2006-06-02
K061183 CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 Confluent Surgical,Inc FMF Class II 2006-06-01
K060352 HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS Health Line International Corporation FPA Class II 2006-05-31
K060258 AUTOFUSER Ace Medical Us, LLC MEB Class II 2006-05-30
K060726 POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) Smart Glove Corp. Sdn Bhd LZA Class I 2006-05-25
K061074 ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES Bright Element Sdn Bhd LZA Class I 2006-05-24
K060909 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Jiangsu Everyguard Plastic Products Co., Ltd. LYZ Class I 2006-05-24
K061192 BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES Ethicon Endo-Surgery, LLC LZA Class I 2006-05-23
K061128 MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM Medrad, Inc. FRN Class II 2006-05-22
K060649 GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 Tyco Healthcare Group LP FLL Class II 2006-05-22
K060240 K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100 K-Jump Health Co., Ltd. FLL Class II 2006-05-19
K061078 BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES Bright Element Sdn Bhd LYY Class I 2006-05-19
K060724 POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) Smart Glove Corp. Sdn Bhd LZA Class I 2006-05-17
K061103 HAEMONETICS 40U RBC FILTER BAG Haemonetics Corp. CAK Class II 2006-05-17
K060036 PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER Smiths Medical MD, Inc. LJT Class II 2006-05-17
K060775 POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF Kossan Latex Industries(M)Sdn Bhd LYY Class I 2006-05-16
K060479 MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM Caesarea Medical Electronics , Ltd. FRN Class II 2006-05-12
K053405 BACSTOP Elcam Medical Acal FMG Class II 2006-05-11
K061143 ROBERTSITE STOPCOCK Halkey-Roberts Corp. FMG Class II 2006-05-10
K060933 SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM Apex Medical Technologies, Inc. MEB Class II 2006-05-09
K060786 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE Ever Light Plastic Products Co., Ltd. LYZ Class I 2006-05-08
K060109 OMI RETRACTABLE SAFETY SYRINGE Vitalcare Group, Inc. MEG Class II 2006-05-05
K060886 POWDERED VINYL PATIENT EXAMINATION GLOVES Wei Fang Jiuzhou Gloves Co., Ltd. LYZ Class I 2006-05-04
K060884 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Wei Fang Jiuzhou Gloves Co., Ltd. LYZ Class I 2006-05-04
K060784 SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED Ever Light Plastic Products Co., Ltd. LYZ Class I 2006-05-01
K060073 TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING Shen Wei (Usa), Inc. LZA Class I 2006-05-01
K060771 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED Kossan Latex Industries(M)Sdn Bhd LZA Class I 2006-05-01
K060147 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE Hongye Plastic Products Co., Ltd. LZA Class I 2006-04-28
K060778 SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE Ever Light Plastic Products Co., Ltd. LYZ Class I 2006-04-28
K060461 V-505 INFA WARMER Atom Medical, Inc. FMT Class II 2006-04-28
K060743 MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES) Safety Syringes, Inc. MEG Class II 2006-04-28
K060866 PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS Carmel Pharma Ab. LHI Class II 2006-04-28
K060887 ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT AngioDynamics, Inc. LJS Class II 2006-04-28
K060339 KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY Tyco Healthcare/Kendall NGT Class II 2006-04-28
K060753 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) Siam Sempermed Corp., Ltd. LZA Class I 2006-04-27
K060392 ASP TITANIUM Sedatelec MQX Class II 2006-04-26
K060733 SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 Barriermed, Inc. LZA Class I 2006-04-24
K060806 HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 Hospira, Inc. FRN Class II 2006-04-21
K053568 BILISOFT PHOTOTHERAPY SYSTEM Lumitex, Inc. LBI Class II 2006-04-17
K052843 BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE Busse Hospital Disposables, Inc. FMI Class II 2006-04-17
K052817 EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF Universal Medical Technologies FRN Class II 2006-04-17
K060341 SHERLOCK TIP LOCATION SYSTEM (TLS) C.R. Bard, Inc. FOZ Class II 2006-04-14
K060231 CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK Elcam Medical Acal FMG Class II 2006-04-13
K060618 CIDEX ACTIVATED DIALDEHYDE SOLUTION Johnson & Johnson Co. MED Class II 2006-04-12
K060782 VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE Smith & Nephew Wound Management FQH Class II 2006-04-12
K060119 MCKINLEY SATURATION CATHETER Mckinley Medical, LLC FRN Class II 2006-04-12
K060658 BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR) Brightway Holdings Sdn. Bhd. LYY Class I 2006-04-10
K053563 HUMAPEN MEMOIR Eli Lilly and Company FMF Class II 2006-04-07
K053413 TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES Terumo Europe N.V. FMF Class II 2006-04-06
K052564 VYGON LEADER-FLEX Vygon Corp. FOZ Class II 2006-04-05
K060082 TIANJIN MEDIS DISPOSABLE INFUSION SET Tianjin Medis International Trade Co., Ltd. FPA Class II 2006-03-31
K060672 ONE STICK Y EXTENSION SET AND VOLUMETER One Stick, LLC FPA Class II 2006-03-31
K053366 NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE Pt Mahakarya Inti Buana LZA Class I 2006-03-30
K060074 INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 Baxter Healthcare Corp FPA Class II 2006-03-29
K053521 PRE-POWDERED STERILE VINYL GLOVE, CLEAR Shijiazhuang Hongxiang Plastics Products Co., Ltd. LYZ Class I 2006-03-29
K060066 VERIFY 3-10 MIN FLASH INTEGRATOR Albert Browne , Ltd. JOJ Class II 2006-03-24
K060007 BD AUTOSHIELD PEN NEEDLE Becton, Dickinson & CO FMI Class II 2006-03-23
K052999 SEMPERFLO INFUSION SYSTEM ETHICON, Inc. MEB Class II 2006-03-22
K060173 ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS ACON Laboratories, Inc. FLL Class II 2006-03-17
K053345 PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D Medcomp LJS Class II 2006-03-17
K060229 POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTE Shun Thai Rubber Gloves Industry Public Co., Ltd. LYY Class I 2006-03-15
K060076 SURGICOUNT SAFETY-SPONGE SYSTEM Surgicount Medical LWH Class I 2006-03-14
K052567 ONE TRAY SEALED STERILIZATION CONTAINER Sterile Containment Technology, LLC KCT Class II 2006-03-13
K060208 CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C, Life-Shield Products, Inc. MEG Class II 2006-03-10
K060337 BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 Sauter AG FLE Class II 2006-03-08
K060103 ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS Albert Browne , Ltd. JOJ Class II 2006-03-07
K052881 VYGON LATEX FREE BIONECTOR Vygon Corp. FOZ Class II 2006-03-02
K052665 GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES Granton Medical , Ltd. FRG Class II 2006-02-27
K052732 ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P Abracair, Inc. FRA Class II 2006-02-24
K050757 FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE Chemence Medical, Inc. KMF Class I 2006-02-23
K050783 ISSYS DRUG FLOW MONITOR Integrated Sensing Systems, Inc. FLN Class II 2006-02-22
K053625 NASALGUARD Trutek Corp NUP Class II 2006-02-22
K060174 SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM Cook, Inc. FOZ Class II 2006-02-17
K053212 RAVEN PROPACT Raven Biological Laboratories, Inc. MRB Class II 2006-02-15
K053389 AESCULAP STERILCONTAINER SYSTEM Aesculap, Inc. FRG Class II 2006-02-15
K060123 LEVELERT II FLUID LEVEL SENSOR Smith & Nephew, Inc. FLN Class II 2006-02-14
K053523 POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW) Shijiazhuang Hongxiang Plastics Products Co., Ltd. LYZ Class I 2006-02-14
K053657 POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE Pt Mahakarya Inti Buana LZA Class I 2006-02-13
K060211 WUZHOU SYRINGE, WITH/WITHOUT NEEDLE Wenzhou Wuzhou Group Co. , Ltd. FMF Class II 2006-02-10
K060095 MODIFICATION TO: VACLOK SYRINGE Wrightmedicaltechnologyinc FMF Class II 2006-02-10
K052594 WILLCARE, MODEL GW-1020 Icu Medical, Inc. FRN Class II 2006-02-10
K052858 SOOTHIES GEL PADS Puronxy, Inc. NXH Class I 2006-02-09
K051699 SEJOY, MODEL MT-403 Sejoy Electronics & Instruments Co., Ltd. FLL Class II 2006-02-06
K043178 GRANTALDER RHAPSODY ACCESS PORT AND CATHETER Grantadler Corportation LJT Class II 2006-02-02
K052731 KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES Daxin LI MQX Class II 2006-02-01
K060006 BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER Braun GmbH FLL Class II 2006-01-31
K053226 ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER Zimmer, Inc. FRN Class II 2006-01-31
K053177 MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E Medtronic Minimed LZG Class II 2006-01-31

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