meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
2006-11-21

Clearances · page 49 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K062500 FLEXPEN NEEDLE Novo Nordisk, Inc. FMI Class II 2006-11-21
K062510 AESCULAP STERILCONTAINER SYSTEM Aesculap FRG Class II 2006-11-17
K063046 NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) Hartalega Sdn Bhd LZA Class I 2006-11-17
K063185 RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES Radiant Innovation, Inc. FLL Class II 2006-11-17
K063280 INJEKT SYRINGE B.Braun Medical, Inc. FMF Class II 2006-11-17
K061933 HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER Hager Worldwide, Inc. FMI Class II 2006-11-16
K062984 MEDLINE HYPODERMIC NEEDLES Medline Industries, Inc. FMI Class II 2006-11-13
K062955 POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE Pt. Haloni Jane LYY Class I 2006-11-09
K062884 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) Suqian Green Glove Co., Ltd. LYZ Class I 2006-11-09
K062422 HUMERAL HEAD, MANUAL DRIVER Vidacare Corporation FMI Class II 2006-11-07
K062482 VENTED VIAL ADAPTER TRANSFER DEVICE Medimop Medical Projects, Ltd. LHI Class II 2006-11-03
K062715 SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW Baoding Guanzhong Glove Co., Ltd. LYZ Class I 2006-11-03
K061233 SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE Pt Mahakarya Inti Buana LYY Class I 2006-11-03
K061316 MEDLINE SURGICAL SPONGE SCANNER Medline Industries, Inc. LWH Class I 2006-11-02
K062642 RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A Rf Surgical Systems, Inc. LWH Class I 2006-11-02
K062917 STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 Wear Safe Malaysia Sdn. Bhd. LYY Class I 2006-11-02
K062323 DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 Smiths Medical MD, Inc. LZG Class II 2006-11-01
K062716 ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 Eco-Rx, Inc. FRA Class II 2006-10-27
K062010 RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES Global Treasure Industries , Ltd. FLL Class II 2006-10-27
K062778 STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED Wear Safe Malaysia Sdn. Bhd. LZA Class I 2006-10-27
K062016 RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES Choice Smart Health Care Co. , Ltd. FLL Class II 2006-10-27
K062260 OSTEOBOOST-BMA Orthos Limited FMF Class II 2006-10-26
K062700 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B.Braun Medical, Inc. FRN Class II 2006-10-26
K052055 SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 Smisson-Cartledge Biomedical, LLC LGZ Class II 2006-10-26
K062699 PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B.Braun Medical, Inc. FRN Class II 2006-10-26
K060971 OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS Omi Manufacturing Pty., Ltd. MEG Class II 2006-10-24
K062143 KOZY COMFORT INFANT POSITIONER Alfred E Mann Inst. For Biomedical Engineering FRP Class I 2006-10-24
K062882 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) Suqian Green Glove Co., Ltd. LYZ Class I 2006-10-20
K061411 TORBOT VASCULAR COMPRESSION GARMENTS Torbut Group, Inc. DWL Class II 2006-10-18
K061661 STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 Advanced Infusion, Inc. MEB Class II 2006-10-18
K052992 CONMED LINVATEC INSTRUMENT STERILIZATION TRAY Conmed Linvatec FRG Class II 2006-10-16
K060772 MANUEL SAFTEY SYRINGE PARTS 1 & 2 Medsafe Asa MEG Class II 2006-10-16
K062520 POWDERED VINYL PATIENT EXAMINATION GLOVES Jiangsu Jaysun Glove Co., Ltd. LYZ Class I 2006-10-11
K062302 MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM Millicore AB KDQ Class II 2006-10-06
K062138 POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE Molnlycke Health Care, Inc. LZA Class I 2006-10-05
K061942 TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 GE Healthcare FLL Class II 2006-09-29
K062365 ARTHREX ASPIRATE KIT Arthrex, Inc. FMF Class II 2006-09-29
K061250 MULTICATH EXPERT Vygon Corp. FOZ Class II 2006-09-29
K061856 V-2200 INFANT INCUBATOR Atom Medical, Inc. FMZ Class II 2006-09-28
K062457 INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES Baxter Healthcare Corporation MEB Class II 2006-09-21
K062448 LYRA ACUPUNCTURE NEEDLES Helio Medical Supplies, Inc. MQX Class II 2006-09-20
K062655 POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Junfei Plastic Products Co., Ltd. LYZ Class I 2006-09-18
K062425 LIFECATH S PICC AND MIDLINE CATHETER Vygon Corp. LJS Class II 2006-09-15
K062608 29G AND 30G K-PACK II NEEDLE Terumo Europe N.V. FMI Class II 2006-09-15
K061662 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Tangshan Luxiong Plastic Products Co., Ltd. LYZ Class I 2006-09-15
K061659 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Tangshan Luxiong Plastic Products Co., Ltd. LYZ Class I 2006-09-15
K052475 VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS Vygon Us, LLC LJS Class II 2006-09-14
K061092 BAXTER DUPLOSPRAY MIS APPLICATOR Micromedics, Inc. FMF Class II 2006-09-13
K062522 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Jiangsu Jaysun Glove Co., Ltd. LYZ Class I 2006-09-08
K062067 TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR Shen Wei (Usa), Inc. LZA Class I 2006-09-06
K052532 IMAX 9.5 STERILIZERS Dental X Srl FLE Class II 2006-09-05
K061071 V-808 ATOM TRANSCAPSULE Atom Medical, Inc. FPL Class II 2006-08-29
K061738 ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD Albert Browne , Ltd. JOJ Class II 2006-08-25
K061551 POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) Medipure Corporation (M) Sdn. Bhd. LYY Class I 2006-08-24
K061194 PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558 Smiths Medical Asd, Inc. MEG Class II 2006-08-24
K061289 ARROW PRESSURE INJECTABLE PICC Arrow International, Inc. LJS Class II 2006-08-24
K061325 BODYGAURD PAIN MANAGER INFUSION SYSTEM Caesarea Medical Electronics , Ltd. FRN Class II 2006-08-24
K062173 MODIFICATION TO BONE GRAFT SYRINGE Wrightmedicaltechnologyinc FMF Class II 2006-08-23
K061721 PEDI-SPIDER STRAP Emergency Products and Research NZD Class I 2006-08-17
K061483 VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES Greiner Bio-One North America, Inc. FMI Class II 2006-08-14
K053519 SAFETY SYRINGE Wuxi Yushou Medical Applicances Co., Ltd. MEG Class II 2006-08-11
K061179 POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER C.R. Bard, Inc. LJS Class II 2006-08-09
K061936 KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 The Kendall Company LJS Class II 2006-08-09
K062108 COMCASET SAFETY IV CATHETER Pitango Medical, Ltd. FOZ Class II 2006-08-08
K053399 VERSALET 7700 CARE CENTER Draeger Medical Infant Care, Inc. FMZ Class II 2006-08-04
K061986 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 Medcomp LJS Class II 2006-08-03
K061492 MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE Tyco Healthcare FMF Class II 2006-08-03
K061424 CELSITE/ CELSITE CONCEPT, ACCESS PORTS Aesculap, Inc. LJT Class II 2006-07-31
K062052 LMT NOMAG IC 3.0 Lmt Lammers Medical Technology GmbH FPL Class II 2006-07-31
K061374 INTUITION INFUSION SETS Unomedical A/S FPA Class II 2006-07-31
K051595 TSO3 OZONE STERILIZER, MODEL 125L Tso3, Inc. FLF Class II 2006-07-26
K061285 SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS Cardinal Health, Alaris Products FPA Class II 2006-07-26
K061724 POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) Smart Glove Corp. Sdn Bhd LZA Class I 2006-07-25
K060037 FITPACK Asp Plastics Pty , Ltd. MMK Class II 2006-07-25
K061275 MEDLINE SYRINGES, MULTIPLE Medline Industries, Inc. FMF Class II 2006-07-19
K053479 VERIFY DRY HEAT LABEL Albert Browne , Ltd. JOJ Class II 2006-07-18
K061553 NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES Yty Industry (Manjung) Sdn Bhd LZA Class I 2006-07-17
K060812 POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE C.R. Bard, Inc. LJT Class II 2006-07-14
K061562 VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR Grand Work Plastic Products Co., Ltd. LYZ Class I 2006-07-11
K060986 HEAD BED Steven H. Warnock, M.D. FRP Class I 2006-07-11
K061771 EZ-CONNECT Vidacare Corporation FPA Class II 2006-07-10
K053554 COMPUFLO Milestone Scientific, Inc. FRN Class II 2006-07-10
K061055 CAREO SAFETY SYRINGE FOR U-100 INSULIN Life-Shield Products, Inc. MEG Class II 2006-07-10
K060785 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR Ever Light Plastic Products Co., Ltd. LYZ Class I 2006-07-07
K061800 CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER Taidoc Technology Corporation FLL Class II 2006-07-07
K061356 POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 Advanced Infusion, Inc. MED Class II 2006-07-03
K061197 KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER Kawasumi Laboratories, Inc. KPE Class II 2006-06-30
K061115 SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216 Gvs Spa FPA Class II 2006-06-30
K061039 AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE Amsino International, Inc. FMF Class II 2006-06-29
K061280 V-2200 INFANT INCUBATOR Neoforce Group, Inc. FMZ Class II 2006-06-27
K060939 RANGER IRRIGATION FLUID WARMING SYSTEM Arizant Healthcare, Inc. LGZ Class II 2006-06-26
K060316 COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS Fresenius Kabi Deutschland GmbH LZH Class II 2006-06-23
K061032 DEPOTONE Imprint Pharmaceuticals Limited FMI Class II 2006-06-21
K053409 3M LIQUID BANDAGE 3M Company KMF Class I 2006-06-19
K042955 CUTICOVER SKIN BARRIER DEVICE D & D Holdings, LLC KMF Class I 2006-06-19
K061409 SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET Precise Medical Products, Ltd. MEB Class II 2006-06-16
K060819 COOL.CLICK 2 Medical House Products Limited KZE Class II 2006-06-16
K060876 ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA Disetronic Medical Systems AG LZG Class II 2006-06-15
K052583 BLUE POWDER FREE NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd LZA Class I 2006-06-14
K061007 GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS Good Medy Enterprise , Ltd. FLL Class II 2006-06-14

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