meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
30
Latest Decision
2005-09-09

Clearances · page 52 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051269 RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES Radiant Innovation, Inc. FLL Class II 2005-09-09
K051251 INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 Shenzhen Dongdixin Technology Co., Ltd. FLL Class II 2005-09-07
K050999 YI XIN STERILE SYRINGE FOR SINGLE USE Jiangxi Sanxin (Eversincere) Medical Devices Group FMF Class II 2005-09-02
K051924 POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW) Shijiazhuang Manful Light Industrial Products Co., LYZ Class I 2005-09-02
K051422 DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE Medisim, Ltd. FLL Class II 2005-09-01
K052016 NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING Sgmp Co., Ltd. LYY Class I 2005-09-01
K051157 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS Micromedics, Inc. KCT Class II 2005-09-01
K051264 COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS Unomedical A/S FPA Class II 2005-09-01
K051669 TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM Migada Plant LHI Class II 2005-09-01
K050889 FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH Crs Medical Diagnostics, Inc. LJS Class II 2005-08-26
K051574 NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE Nipro Medical Corp. FMF Class II 2005-08-26
K052052 HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 Hospira, Inc. FRN Class II 2005-08-24
K050906 VITALCARE I.V. ADMINISTRATION SET Vitalcare Group, Inc. FPA Class II 2005-08-23
K051690 VYGON NUTRILINE CATHETERS Vygon Corp. LJS Class II 2005-08-19
K051643 STERRAD STERILIZER CYCLESURE TEST PACK Advanced Sterilization Products FRC Class II 2005-08-19
K051985 BIOVALVE MINI-JECT NEEDLEFREE INJECTOR Biovalve Technologies, Inc. KZE Class II 2005-08-17
K050971 BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) Biovalve Technologies, Inc. LZG Class II 2005-08-16
K051923 POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED) Shijiazhuang Wonder Plastic Co., Ltd. LYZ Class I 2005-08-16
K052034 TERUMO SYRINGE WITH/WITHOUT NEEDLE Terumo Medical Corp. FMF Class II 2005-08-16
K052128 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER 3M Company FRC Class II 2005-08-16
K051930 DRUG ACCESS SPIKE Medegen Medical Manufacturing Services FMF Class II 2005-08-16
K051777 NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) Hartalega Sdn Bhd LZA Class I 2005-08-12
K051370 STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 Baxter Healthcare Corp JOL Class II 2005-08-12
K051660 DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM Coltene/Whaledent, Inc. KMH Class II 2005-08-04
K051378 POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Medline LZA Class I 2005-08-03
K051437 CML 1000 Icu Medical, Inc. FPA Class II 2005-08-03
K052006 POWDER-FREE VINYL EXAM GLOVES Baoding Guanzhong Glove Co., Ltd. LYZ Class I 2005-08-03
K051045 SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 Spectrx, Inc. FRN Class II 2005-08-02
K051935 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) Shijiazhuang Wonder Plastic Co., Ltd. LYZ Class I 2005-08-02
K051683 POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING Shen Wei (Usa), Inc. LYZ Class I 2005-08-01
K051939 MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR Medegen Medical Manufacturing System FPA Class II 2005-08-01
K051393 DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR Ever Global Enterprise Corporation LYZ Class I 2005-07-27
K050463 CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER Taidoc Technology Corporation FLL Class II 2005-07-27
K050542 MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER Marian Medical, Inc. LJS Class II 2005-07-26
K051778 NITRILE POWDERED EXAMINATION GLOVES (BLUE) Hartalega Sdn Bhd LZA Class I 2005-07-26
K051194 BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 Becton, Dickinson & CO LJS Class II 2005-07-25
K050570 MILTEX RIGID STERILIZATION CONTAINER SYSTEM Miltex, Inc. KCT Class II 2005-07-25
K051720 SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE Synthes (Usa) FMF Class II 2005-07-25
K051662 VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) Grand Work Plastic Products Co., Ltd. LZA Class I 2005-07-22
K051333 NITRILE EXAMINATION GLOVES, POWDER FREE Shun Thai Rubber Gloves Industry Co., Ltd. LZA Class I 2005-07-22
K041849 TURBO-FLO PICC Cook, Inc. LJS Class II 2005-07-21
K051329 STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS) Siam Sempermed Corp., Ltd. LYY Class I 2005-07-19
K051253 MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) Baxter Healthcare Corp MEA Class II 2005-07-15
K051723 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW) Zibo Sinocare Plastic Products Co., Ltd. LYZ Class I 2005-07-15
K051142 ANGIODYNAMICS TUMESCENT INFUSION DEVICE AngioDynamics, Inc. FPA Class II 2005-07-13
K050797 TISSU-TRANS Shippert Medical Technologies Corp. KYZ Class I 2005-07-13
K051465 POWDERED LATEX PATIENT EXAMINATION GLOVES P.T. Anlis Abadi Internasional LYY Class I 2005-07-12
K051009 HUBER CLEAR SAFETY INFUSION SET Now Medical Distribution, Inc. FPA Class II 2005-07-12
K050968 POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES Pt. Medisafe Technologies LZA Class I 2005-07-12
K051372 POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR) Platinum Glove Industries Sdn. Bhd. LZA Class I 2005-07-07
K051498 DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR Ever Global Enterprise Corporation LYZ Class I 2005-07-06
K051474 SYMBIOS DISPOSABLE INFUSION PUMP KIT Symbios Medical Products, LLC MEB Class II 2005-07-01
K041496 PENTATRASFU BLOOD TRANSFUSION SETS Pentaferte S.P.A BRZ Class II 2005-06-30
K051417 6 FR FL POWERHOHN AND POWERLINE CATHETER C.R. Bard, Inc. LJS Class II 2005-06-30
K050434 SHL DISPOSABLE AUTOINJECTOR Shl Medical, USA KZH Class II 2005-06-24
K051345 COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET) Glovco (M) Sdn. Bhd. LYY Class I 2005-06-23
K051499 INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET Medegen Medical Manufacturing Services FPA Class II 2005-06-22
K051148 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Sinocare Plastic Products Co., Ltd. LYZ Class I 2005-06-21
K051233 OMRON MODEL 514N TYMPANIC THERMOMETER Omron Healthcare, Inc. FLL Class II 2005-06-21
K051154 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) Hebei Manful Import & Export Co., Ltd. LYZ Class I 2005-06-20
K050805 30 ML OR 60 ML PEDI-SYRINGE FILTER Blood Products Specialties, LLC BRZ Class II 2005-06-20
K051317 POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR Platinum Glove Industries Sdn. Bhd. LZA Class I 2005-06-20
K051318 POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR) Platinum Glove Industries Sdn. Bhd. LZA Class I 2005-06-17
K050998 CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 Confluent Surgical,Inc FMF Class II 2005-06-15
K050931 6 FR DL POWERPICC CATHETER C.R. Bard, Inc. LJS Class II 2005-06-15
K051156 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW) Shijiazhuang Manful Light Industrial Products Co., LYZ Class I 2005-06-14
K050114 SUPERCATH Z3V Togo Medikit Co., Ltd. FOZ Class II 2005-06-09
K050277 CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) Hartalega Sdn Bhd LYY Class I 2005-06-07
K051166 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET Gloveco, Inc. LYZ Class I 2005-06-07
K051347 KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE Kimberly-Clark Corp. LZA Class I 2005-06-07
K051152 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) Zibo Sinocare Plastic Products Co., Ltd. LYZ Class I 2005-06-03
K050734 COOL.CLICK Bioject, Inc. KZE Class II 2005-06-03
K041096 WAGNER STERISET STERILIZATION CONTAINER Wagner GmbH FRG Class II 2005-06-03
K051173 SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK Spsmedical Supply Corp. FRC Class II 2005-05-27
K051252 MICROPUMP MP-101 Micrel Medical Devices S.A. FRN Class II 2005-05-27
K050185 POWERHOHN AND POWERLINE CATHETERS C.R. Bard, Inc. LJS Class II 2005-05-26
K043149 FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) Firstline, LLC LZA Class I 2005-05-25
K043249 ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE Atrion Medical Products, Inc. FMI Class II 2005-05-25
K050528 POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) Spi Gloves Sdn. Bhd. LZA Class I 2005-05-19
K051079 HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY Hospicare, Inc. MRZ Class II 2005-05-19
K051153 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) Hebei Manful Import & Export Co., Ltd. LYZ Class I 2005-05-18
K050753 STRYKER DISCMONITOR Stryker Instruments FMF Class II 2005-05-18
K042610 DR. THEISS ALERGOL POLLEN BLOCKER CREAM Dr. Theiss Naturwaren GmbH NUP Class II 2005-05-16
K042450 STERRAD NX CHALLENGE PACK Advanced Sterilization Products FRC Class II 2005-05-12
K050600 MINILOC SAFETY INFUSION SET Specialized Health Products, Intl. FPA Class II 2005-05-12
K041984 ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT Best Sanitizers, Inc. MED Class II 2005-05-11
K050464 ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 Ultimed, Inc. FMI Class II 2005-05-11
K051100 MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q Microlife Intellectual Property GmbH FLL Class II 2005-05-11
K043466 PAINPUMP2 Stryker Instruments FRN Class II 2005-05-10
K050116 UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES Uniqsafe Biomeditech Co., Ltd. MEG Class II 2005-05-09
K050312 AMIGO INSULIN PUMP Nipro Diabetes Systems, Inc. LZG Class II 2005-05-09
K041360 ALDAHOL III HIGH-LEVEL DISINFECTANT Healthpoint, Ltd. MED Class II 2005-05-05
K040916 VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE Vitalcare Group, Inc. LYZ Class I 2005-05-04
K050654 AMSINO I.V. START KIT Amsino International, Inc. LRS Class II 2005-05-02
K050495 EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) Baxter Healthcare Corp., Bioscience FMF Class II 2005-05-02
K050324 INFPUMP INFILTRATION PUMP Carolina Medical, Inc. FRN Class II 2005-04-27
K050837 REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE GE Healthcare FLL Class II 2005-04-27
K042917 STAT MEDICAL PEN NEEDLE Emergogroup, Inc. FMI Class II 2005-04-22
K042116 STERRAD NX STERILIZER Advanced Sterilization Products MLR Class II 2005-04-22
K050716 ISCIENCE SURGICAL VISCOINJECTOR Iscience Surgical Corporation MRH Class II 2005-04-21

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