meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
27
Latest Decision
2006-01-25

Clearances · page 51 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K052666 NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN Ascend Eagle, Inc. LYY Class I 2006-01-25
K052773 B. BRAUN 0.2 MICRON FILTER B.Braun Medical, Inc. FMF Class II 2006-01-24
K052955 NITRILE BLUE POWDERED EXAMINATION GLOVES Great Glove Sdn Bhd LZA Class I 2006-01-19
K052985 POWDER FREE VINYL EXAMINATION GLOVE Tg Medical (China) Incorporation LYZ Class I 2006-01-19
K042504 CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER Myco Medical Supplies, Inc. FOZ Class II 2006-01-19
K052729 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) Shijiazhuang Brilliant Ocean Plastic Co., Ltd. LYZ Class I 2006-01-19
K053259 DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE Practical Protective Plastic Manufactory , Ltd. LYZ Class I 2006-01-18
K051566 PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER Proton Healthcare , Ltd. FLL Class II 2006-01-17
K052723 SEVEN STAR NEEDLE Helio Medical Supplies, Inc. MQX Class II 2006-01-13
K053501 POWERPICC Bard Access Systems, Inc. LJS Class II 2006-01-13
K053049 ALARIS SAFETY MALE LUER Cardinal Health, Alaris Products FPA Class II 2006-01-12
K052984 POWDERED VINYL EXAMINATION GLOVE Tg Medical (China) Incorporation LYZ Class I 2006-01-11
K053106 TEGO, MODEL D1000 Icu Medical, Inc. FPA Class II 2006-01-10
K052725 PROTECTOR NEEDLE SHEATH PROP Certol International, LLC FMI Class II 2005-12-28
K052790 SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD Cardinal Health, Alaris Products LHI Class II 2005-12-23
K051041 INSULIN PUMP Abbott Diabetes Care, Inc. LZG Class II 2005-12-23
K052397 CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) Life-Shield Products, Inc. MEG Class II 2005-12-22
K052846 TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE Maanshan Medical Instruments Co., Ltd. MQX Class II 2005-12-22
K053470 NOVOFINE 32G TIP Novo Nordisk, Inc. FMI Class II 2005-12-21
K052923 GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES Great Glove (China), Inc. LYZ Class I 2005-12-21
K051694 CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE Medical Device Manufacturer (Thailand) , Ltd. MEG Class II 2005-12-21
K052956 NITRILE BLUE POWDER FREE EXAMINATION GLOVE Great Glove Sdn Bhd LZA Class I 2005-12-21
K052922 GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES Great Glove (China), Inc. LYZ Class I 2005-12-20
K052845 B-CARE POWDERED LATEX EXAMINATION GLOVES B-Care Industries Co., Ltd. OPE 2005-12-16
K051828 NIPRO SUREFUSER AMBULATORY INFUSION PUMP Nipro Medical Corporation MEB Class II 2005-12-15
K052635 TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW Teh Loong Corp. LYZ Class I 2005-12-13
K051242 WINNER SELF SEAL STERILIZATION POUCH Winner Medical (Usa), Inc. KCT Class II 2005-12-13
K053120 STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES Excelsior Medical Corp. FOZ Class II 2005-12-09
K053129 NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 Nexus Medical, LLC FPA Class II 2005-12-08
K052887 SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS Terumo Europe N.V. FPA Class II 2005-12-08
K051300 ROBIN HOOD VEST Kamber Corporation FRP Class I 2005-12-08
K052451 MPS ACACIA MEDFLO ELASTOMERIC PUMP Mps Acacia MEB Class II 2005-12-08
K052221 AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP Sorenson Medical, Inc. FRN Class II 2005-12-08
K050526 POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR Spi Gloves Sdn. Bhd. LYY Class I 2005-12-06
K051101 VERIFY FLASH INTEGRATOR Albert Browne , Ltd. JOJ Class II 2005-12-06
K051324 MEDI BUTLER Medi USA, LP DWL Class II 2005-12-05
K052445 DUOPROSS NEEDLE Duopross Meditech Corporation FMI Class II 2005-12-05
K052728 POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES M/S. Kanam Latex Industries Pvt. , Ltd. LYY Class I 2005-12-05
K052388 SERIM PERACETIC ACID CHEMICAL INDICATOR Serim Research Corp. JOJ Class II 2005-12-01
K052892 SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 Barriermed Glove Co. LZA Class I 2005-11-30
K052387 ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX Arthrex, Inc. LZB Class I 2005-11-29
K052431 MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 Medtronic Minimed FPK Class II 2005-11-29
K052432 MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 Medtronic Minimed FPA Class II 2005-11-29
K052568 ESTEEM STRETCHY VINYL GLOVE WITH COATING Cardinalhealth LYZ Class I 2005-11-28
K052667 ARTSANA PISTON AND INSULIN SYRINGES Artsana S.P.A FMF Class II 2005-11-25
K052218 CRONO FIVE AND CRONO PCA 50 Cane S.R.L. FRN Class II 2005-11-23
K051102 OMNIPICC PI Rita Medical Systems, Inc. LJS Class II 2005-11-23
K050800 NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS Caesarea Medical Electronics , Ltd. FRN Class II 2005-11-23
K052561 TERUMO MICRO TAPERED PEN NEEDLE Kofu Factory of Terumo Corp. FMI Class II 2005-11-23
K051672 POWERPICC Bard Access Systems, Inc. LJS Class II 2005-11-23
K052612 DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR Shanghai Antares Industries, Inc. LYZ Class I 2005-11-22
K052502 NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES Yty Industry (Manjung) Sdn Bhd LZA Class I 2005-11-18
K051568 CADD-MS 3 AMBULATORY INFUSION PUMP Smiths Medical MD, Inc. FRN Class II 2005-11-17
K052408 EZ-IO Vidacare Corporation FMI Class II 2005-11-17
K052252 CONTRAST MEDIA TRANSFER SETS B.Braun Medical, Inc. FPA Class II 2005-11-16
K052474 NIPRO HYPODERMIC NEEDLE Nipro Medical Corp. FMI Class II 2005-11-10
K052636 TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW Teh Loong Corp. LYZ Class I 2005-11-10
K052075 PROCEDUR-10 Avanca Medical Devices, Inc. FMF Class II 2005-11-09
K052709 POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE Pt.Shamrock Manufacturing Corp. LYY Class I 2005-11-08
K052877 POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE Syntex Healthcare Products Co., Ltd. LZA Class I 2005-11-08
K051082 MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) Medtrade Products , Ltd. KMF Class I 2005-11-08
K052195 EZ-MIO MANUAL DRIVER Vidacare Corporation FMI Class II 2005-11-02
K052722 LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS Hospira, Inc. FPA Class II 2005-11-02
K052890 NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E Siam Sempermed Corp., Ltd. LZA Class I 2005-10-31
K052849 INFRARED THERMOMETER, FDIR-V1 Famidoc Technology Co., Ltd. FLL Class II 2005-10-26
K051800 IN6 SAFETY SYRINGE, MODEL 3ML In6 Incuvestor, Inc. MEG Class II 2005-10-21
K051991 POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE C.R. Bard, Inc. LJS Class II 2005-10-20
K051056 VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR Albert Browne , Ltd. FRC Class II 2005-10-20
K051641 ALARIS SYSTEM PC UNIT, MODEL 8001 Cardinal Health, Alaris Products FRN Class II 2005-10-20
K051992 POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM Vidacare Corporation FMI Class II 2005-10-20
K052103 EXEL SECURE TOUCH II SAFETY SYRINGE Exelint Intl. Co. MEG Class II 2005-10-19
K052173 VITAGEL SURGICAL HEMOSTAT SPRAY SET Orthovita, Inc. FMF Class II 2005-10-19
K052085 STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES Asia-Med GmbH and CO KG MQX Class II 2005-10-14
K052171 ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE Zimmer, Inc. FRN Class II 2005-10-13
K052658 SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET Renascence Medical, Inc. FPA Class II 2005-10-12
K052634 TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE Teh Loong Corp. LYZ Class I 2005-10-11
K051869 NEOBLUE COZY LED PHOTOTHERAPY SYSTEM Natus Medical, Inc. LBI Class II 2005-10-07
K051987 FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE Pt. Mandiri Inti Buana LYY Class I 2005-10-06
K051943 SUREFLOW SAFETY INFUSION DEVICE Intrasafe Medical, LLC FPA Class II 2005-10-04
K051783 ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES Artsana S.P.A FMI Class II 2005-10-04
K052516 STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 Steritec Products, Inc. JOJ Class II 2005-10-03
K052273 POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE Pt Mahakarya Inti Buana LYY Class I 2005-09-30
K051913 POWDERED LATEX PATIENT EXAMINATION GLOVES Shinemound Enterprise, Inc. LYY Class I 2005-09-30
K052551 DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE Devon Safety Products, Inc. FMF Class II 2005-09-30
K051404 B-CARE POWDER FREE LATEX EXAMINATION GLOVES B-Care Industries Co., Ltd. LYY Class I 2005-09-27
K051667 EZ-JECT Indolor, Ltd. KZH Class II 2005-09-27
K051865 TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR Terumo Medical Corp. MEG Class II 2005-09-27
K051835 NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702 Norm Pacific Automation Corp. FLL Class II 2005-09-23
K051355 VANISHPOINT I.V. CATHETER Retractable Technologies, Inc. FOZ Class II 2005-09-23
K051762 SAF-T-SYRINGE/SAF-T-NEEDLE Safety Medical International, Incorporated MEG Class II 2005-09-23
K051873 DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES GE Healthcare FLL Class II 2005-09-20
K052382 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE Pt.Shamrock Manufacturing Corp. LZA Class I 2005-09-15
K051899 BD PEN NEEDLE Becton, Dickinson & CO FMI Class II 2005-09-13
K052217 CRONO SUPER PID Cane S.R.L. FRN Class II 2005-09-13
K050760 ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE Roche Diagnostics Corp. LZG Class II 2005-09-13
K052219 CRONO GO. Cane S.R.L. FRN Class II 2005-09-13
K052214 PRE-POWDERED STERILE EXAM GLOVES Kanam Latex Industries Pvt. , Ltd. LYY Class I 2005-09-13
K052117 I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) I-Flow Corp. MEB Class II 2005-09-09
K052330 TRU-SWAB STOCOCK Medegen Medical Manufacturing Services FMG Class II 2005-09-09
K052389 I-PORT Patton Medical Devices FOZ Class II 2005-09-09

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