meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
30
Latest Decision
2003-07-14

Clearances · page 58 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K032008 VAXCEL WITH PASV PORT, MODEL 45-213 Boston Scientific Corp LJT Class II 2003-07-14
K024007 SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J Sunder Biomedical Tech. Co., Ltd. FOZ Class II 2003-07-14
K031808 MEDRAD SWABBABLE VALVE TRANSFER SET Medrad, Inc. FPK Class II 2003-07-11
K031060 NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES Lhasa Medical, Inc. MQX Class II 2003-07-11
K031716 SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE Asia-Med GmbH and CO KG MQX Class II 2003-07-10
K032044 X-PROT DUO PORT C.R. Bard, Inc. LJT Class II 2003-07-10
K031199 ENTERALITE INFINITY ENTERAL FEEDING PUMP Zevex Intl., Inc. LZH Class II 2003-07-09
K031913 VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR Arista Latindo Industrial Ltd. P.T LYZ Class I 2003-07-09
K031453 TERUMO SURGUARD 2 SAFETY NEEDLE Terumo Medical Corp. FMI Class II 2003-07-08
K031163 SEZ SAFETY SYRINGE Sez Corporation MEG Class II 2003-07-08
K031905 DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030 Actherm, Inc. FLL Class II 2003-07-07
K031718 LIFEVALVE CENTRAL VENOUS CATHTER Horizon Medical Products, Inc. LJS Class II 2003-07-02
K023668 JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR Jms North America Corp. FPA Class II 2003-07-01
K031783 SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005 Intravascular Incorporated FPA Class II 2003-07-01
K031754 FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE Pt. Mandiri Inti Buana LYY Class I 2003-06-30
K031591 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED Perusahaan Getah Asas Sdn. Bhd. LZA Class I 2003-06-26
K031414 POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE Perusahaan Getah Asas Sdn. Bhd. LYY Class I 2003-06-26
K014013 H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM H & W Technology, LLC FLF Class II 2003-06-25
K031096 MODIFICATION TO TRANSPORT INCUBATOR 185 International Biomedics, Inc. FPL Class II 2003-06-24
K031200 MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE Becton, Dickinson & CO FMI Class II 2003-06-24
K031556 VIVATHERM THEMPERATURE MEASUREMENT SYSTEM Vivant Medical, Inc. FLL Class II 2003-06-23
K031065 SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5 Syringex Medical, Inc. MEG Class II 2003-06-23
K031626 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT AngioDynamics, Inc. LJS Class II 2003-06-19
K031384 MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G Yty Industry (Manjung) Sdn Bhd LZA Class I 2003-06-17
K030531 MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER Minimed, Inc. LZG Class II 2003-06-17
K031058 CORD STICK MULTIPLE DRAW SYSTEM Cord Stick Corp. FMI Class II 2003-06-13
K031021 CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE Perusahaan Getah Asas Sdn. Bhd. LYY Class I 2003-06-13
K030993 NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS Sgmp Co., Ltd. LYY Class I 2003-06-12
K030994 NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS Sgmp Co., Ltd. LYY Class I 2003-06-12
K031104 POWDERED VINYL EXAM GLOVES, WHITE Glormed Intl., Inc. LYZ Class I 2003-06-10
K031113 DISPOSABLE POWDER FREE VINYL EXAM GLOVES Elite International, Inc. LYZ Class I 2003-06-10
K031594 BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY M.K. Meditech Co. , Ltd. MEG Class II 2003-06-06
K022394 EZMANAGER PLUS Animas Corp. LZG Class II 2003-06-05
K030636 C-PORT Clinisurg Vascular Products, LLC LJT Class II 2003-06-05
K021993 SHANCHUAN SYRINGE Shangdong Zibo Shanchuan Medical Instruments Co. FMF Class II 2003-06-03
K021557 SPECTRUM SILICONE CATHETER Cook, Inc. FOZ Class II 2003-05-30
K031279 SURSHIELD SAFETY WINGED BLOOD COLLECTION SET Terumo Medical Products Hangzhou Co., Ltd. FPA Class II 2003-05-30
K030976 CAREO RETRACTABLE SAFETY SYRINGE Life-Shield Products, Inc. MEG Class II 2003-05-30
K031266 SURSHIELD SAFETY WINGED INFUSION SET Terumo Corp. FPA Class II 2003-05-30
K030661 STRYKER PAINPUMP2 Stryker Instruments MEA Class II 2003-05-30
K012889 BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT Pascal Co., Inc. MED Class II 2003-05-27
K031171 DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES Synmertex Co, Ltd. LYZ Class I 2003-05-23
K031361 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP Deltec, Inc. FPA Class II 2003-05-23
K031120 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES Synmertex Co, Ltd. LYZ Class I 2003-05-23
K031076 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR Synmertex Co, Ltd. LYZ Class I 2003-05-23
K031020 FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE Pt. Mandiri Inti Buana LYY Class I 2003-05-21
K030576 ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II The Anspach Effort, Inc. FRN Class II 2003-05-21
K031134 DISPOSABLE POWDERED VINYL EXAM GLOVES Elite International, Inc. LYZ Class I 2003-05-20
K031407 ROSS EMBRACE ENTERAL PUMP Ross Product Div. Abbott Laboratories LZH Class II 2003-05-20
K023740 SYREX PRE-FILLED SYRINGE Excelsior Medical Corp. NZW Class II 2003-05-13
K031259 MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER Getinge USA, Inc. FLE Class II 2003-05-12
K021813 HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM Hydrocision, Inc. FQH Class II 2003-05-09
K030680 SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR Spsmedical Supply Corp. JOJ Class II 2003-05-09
K022978 STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS Case Medical, Inc. FRG Class II 2003-05-09
K031293 SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE Shijiazhuang Eversharp Plastic Products Co., Ltd. LYZ Class I 2003-05-09
K023253 PEDIATRIC CENTRAL VENOUS CATHETER KIT B.Braun Medical, Inc. FOZ Class II 2003-05-06
K031072 DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E Shanghai Palomar Mountain Industries, Inc. LYZ Class I 2003-05-06
K030580 SURETEMP PLUS Welch Allyn, Inc. FLL Class II 2003-05-06
K031129 POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC C.R. Bard, Inc. LJS Class II 2003-05-05
K031062 TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) Taiject Medical Device Co., Ltd. MEG Class II 2003-05-02
K031226 STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products FRC Class II 2003-05-02
K030997 POWDERED VINYL EXAM GLOVES, WHITE Heyuan Hongli Industries, Inc. LYZ Class I 2003-05-02
K030207 NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 Shanghai Motex Healthcare Co., Ltd. LZA Class I 2003-05-02
K030415 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT AngioDynamics, Inc. LJS Class II 2003-04-30
K031185 ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE Abbott Laboratories FRN Class II 2003-04-30
K020418 GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES P.T. Greenleaf MEA Class II 2003-04-29
K020421 GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES Hennig Enterprises Europe Srl MEA Class II 2003-04-29
K030283 BABY POD Prism Enterprises, Inc. FPP Class I 2003-04-22
K030885 MODIFICATION TO STRYKER PAINPUMP2 Stryker Instruments FRN Class II 2003-04-18
K030927 POWDERED VINYL EXAM GLOVES, WHITE Copioumed Intl., Inc. LYZ Class I 2003-04-17
K030208 IMBIBE II SYRINGE Orthovita, Inc. FMF Class II 2003-04-16
K030385 IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR Kawasumi Laboratories America, Inc. FPA Class II 2003-04-15
K024207 VINCO BRAND ACUPUNCTURE NEEDLE Helio Medical Supplies, Inc. MQX Class II 2003-04-14
K031022 PROTEC-TOP, STERIDENT, BENTO Ronpak, Inc. FRG Class II 2003-04-14
K030270 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON Medcomp LJS Class II 2003-04-11
K023412 THERMO BUDDY, MODELS TB-100, TB-110, TB-120 Hubdic Co., Ltd. FLL Class II 2003-04-09
K023614 STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM Case Medical, Inc. FRG Class II 2003-04-07
K030136 DRIP ALERT Drip Alert, Inc. FLN Class II 2003-04-07
K030459 MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) Alaris Medical Systems, Inc. FRN Class II 2003-04-04
K030245 NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR Arista Latindo Industrial Ltd. P.T LZA Class I 2003-04-04
K030673 FLEXIBLE TIP THERMOMETER, MODEL 011206 Global Treasure Industries , Ltd. FLL Class II 2003-04-04
K023290 STERRAD 50 & STERRAD 100S STERILIZERS Advanced Sterilization Products FLF Class II 2003-04-03
K030888 EVA EMPTY SOLUTION CONTAINER Metrix Co. KPE Class II 2003-04-02
K030323 MRI-CADDY Mammendorfer Institute For Physics & Medicine GmbH FRN Class II 2003-04-02
K030936 RITA CLIPS FOR INFUSION PUMPS Rita Medical Systems, Inc. MRZ Class II 2003-04-01
K030094 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR Shanghai Palomar Mountain Industries, Inc. LYZ Class I 2003-04-01
K030571 ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER Ethicon Endo-Surgery, Inc. FOZ Class II 2003-03-28
K030325 POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM Pt.Shamrock Manufacturing Corp. LYY Class I 2003-03-28
K030386 POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE Shamrock Manufacturing Company LZA Class I 2003-03-28
K020189 EXEL BUTTERFLY SCALP VEIN SET Exelint International, Co. FPA Class II 2003-03-27
K030789 AMSCO CENTURY STEAM STERILIZER STERIS Corporation FLE Class II 2003-03-26
K030273 GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE Pt. Wrp Buana Multicorpora LYY Class I 2003-03-26
K023754 VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E Arista Latindo Industrial Ltd. P.T LYZ Class I 2003-03-25
K030284 POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) Pt. Smartglove Indonesia LZA Class I 2003-03-25
K023658 STERILIZATION CASES AND TRAYS Carr Metal Products, Inc. FRG Class II 2003-03-25
K030658 STANDARD THERMOMETER Global Treasure Industries , Ltd. FLL Class II 2003-03-25
K030134 LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE Pt.Shamrock Manufacturing Corp. LYY Class I 2003-03-25
K023753 VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E Arista Latindo Industrial Ltd. P.T LYZ Class I 2003-03-25
K030560 POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE Pt.Shamrock Manufacturing Corp. LYY Class I 2003-03-21
K030032 CROSSEAL APPLICATION DEVICE Omrix Biopharmaceuticals, Inc. FMI Class II 2003-03-21

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