Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 39
- Latest Decision
- 2008-07-01
Clearances · page 45 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K080695 | MOBILE I.V. SYSTEMS 10,20,60 | Northwind Technologies, Corp. | FPA | Class II | 2008-07-01 |
| K081027 | KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) | Kimberly-Clark Corp. | LZA | Class I | 2008-06-30 |
| K080604 | PRESSURE INJFECTABLE PICC | Arrow International, Inc. | LJS | Class II | 2008-06-27 |
| K080600 | ULTIMED ULTICARE SAFETY SYRINGE | Ultimed, Inc. | MEG | Class II | 2008-06-25 |
| K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM | Animas Corp. | LZG | Class II | 2008-06-24 |
| K081160 | AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES | Avita Corporation | FLL | Class II | 2008-06-24 |
| K073577 | SHARPS TRANSPORT TUBE, MODEL 50035 | Sharps Compliance, Inc. | MMK | Class II | 2008-06-23 |
| K081094 | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 | Olympic Medical Corp. | MEC | Class II | 2008-06-20 |
| K080536 | MICRO-TOUCH NITRAFREE | Ansell Healthcare Products, LLC | LZA | Class I | 2008-06-19 |
| K072602 | VACUETTE PREMIUM SAFETY NEEDLE SYSTEM | Medpro Safety Products, Inc. | FMI | Class II | 2008-06-18 |
| K080297 | MEDRAD INTEGO PET INFUSION SYSTEM | Medrad, Inc. | FRN | Class II | 2008-06-17 |
| K081427 | BROWNE OPA TEST STRIP | STERIS Corporation | JOJ | Class II | 2008-06-11 |
| K081399 | AVIATOR TRANSPORT INCUBATOR | International Biomedical, Ltd. | FPL | Class II | 2008-06-06 |
| K070844 | NILIMEDIX ADI | Nilimedix , Ltd. | LZG | Class II | 2008-06-06 |
| K081311 | POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER | C.R. Bard, Inc. | LJT | Class II | 2008-06-04 |
| K080904 | FEEL-FINE INSULIN PEN NEEDLE | Feel Tech | FMI | Class II | 2008-06-04 |
| K081449 | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER | Ultimed, Inc. | MMK | Class II | 2008-06-03 |
| K072080 | NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, | Smiths Medical Asd, Inc. | LGZ | Class II | 2008-06-02 |
| K080198 | TSO3 OZONE STERILIZATION WRAP | Tso3, Inc. | FRG | Class II | 2008-05-30 |
| K073051 | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY | Medrad, Inc. | FRN | Class II | 2008-05-30 |
| K073244 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES | STERIS Corporation | FRC | Class II | 2008-05-28 |
| K081256 | WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H | Rio Flexon Technology Co., Ltd. | FLL | Class II | 2008-05-27 |
| K071977 | TARRY MEDICAL TEMPERATURE PROBES | Tarry Medical Products, Inc. | FMZ | Class II | 2008-05-23 |
| K080937 | POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE | Gx Corporation Sdn Bhd | LZA | Class I | 2008-05-23 |
| K073684 | SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL | Sheffield Industries, Div. of Faria , Ltd. | KMJ | Class I | 2008-05-22 |
| K073551 | SMITH & NEPHEW INSTRUMENT TRAYS | Smith & Nephew Inc., Endoscopy Div. | KCT | Class II | 2008-05-21 |
| K081009 | NEUTROPHASE | Novabay Pharmaceuticals | KMF | Class I | 2008-05-20 |
| K081040 | POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE | Pt.Shamrock Manufacturing Corp. | LYY | Class I | 2008-05-20 |
| K072300 | POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM | Perusahaan Pelindung Getah (M) Sdn Bhd | LYY | Class I | 2008-05-16 |
| K080954 | T34L SYRINGE DRIVER | Caesarea Medical Electronics , Ltd. | FRN | Class II | 2008-05-16 |
| K080227 | ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM | Roche Diagnostics Corp. | MRZ | Class II | 2008-05-15 |
| K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE | Animas Corp. | MRZ | Class II | 2008-05-15 |
| K080165 | SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) | Platinum Glove Industries Sdn. Bhd. | LZA | Class I | 2008-05-14 |
| K080660 | IV ADMINISTRATION SET | U.S. Safety Syringes Co., Inc. | FPA | Class II | 2008-05-13 |
| K080665 | NOVOLET | U.S. Safety Syringes Co., Inc. | FPA | Class II | 2008-05-13 |
| K080750 | BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR | STERIS Corporation | JOJ | Class II | 2008-05-12 |
| K080759 | THERMOFLASH LX-26 | Jxb Co. Ltd Guangzhou (China) | FLL | Class II | 2008-05-12 |
| K071999 | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | Tangshan Hongyun Plastic Products Co., Ltd. | LYZ | Class I | 2008-05-08 |
| K072084 | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. | LYZ | Class I | 2008-05-08 |
| K081162 | TEMPTOUCH DERMAL THERMOMETER | Diabetica Solutions, Inc. | FLL | Class II | 2008-05-08 |
| K080645 | STD MED PRIMO PORT POLY | Std Med, Inc. | LJT | Class II | 2008-05-02 |
| K080989 | UNIVERSAL VIAL ACCESS SPIKE | Icu Medical, Inc. | FMF | Class II | 2008-05-02 |
| K073192 | POWDERED VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Prosperous Plastic Co., Ltd. | LYZ | Class I | 2008-05-02 |
| K080981 | EAR THERMOMETER, MODELS ST66 AND ST67 | Mesure Technology Co., Ltd. | FLL | Class II | 2008-05-02 |
| K080307 | PROCHEM INDICATOR TAPE | Raven Laboratories | JOJ | Class II | 2008-05-01 |
| K072408 | EMU-GRAPH EMULATOR, MODEL CI 131 | Steritec Products Mfg Co, Inc. | JOJ | Class II | 2008-04-30 |
| K080520 | NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM | Siam Sempermed Corp., Ltd. | LZA | Class I | 2008-04-30 |
| K073471 | VANTAGECATH INTRAVASCULAR CATHETER | Advantage Medical Device | FOZ | Class II | 2008-04-30 |
| K073168 | AESCULAP PRIMELINE CONTAINER LTD. | Aesculap, Inc. | KCT | Class II | 2008-04-28 |
| K073356 | PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 | Medtronic Minimed | LZG | Class II | 2008-04-25 |
| K080743 | LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP | Smiths Medical MD, Inc. | FRN | Class II | 2008-04-25 |
| K080235 | SAFETY INFUSION SET | Greiner Bio-One Vacuette North America | FMI | Class II | 2008-04-24 |
| K080865 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | Pyng Medical Corp. | FMI | Class II | 2008-04-24 |
| K080174 | PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C | Cardio Med Supplies, Inc. | LHI | Class II | 2008-04-23 |
| K063810 | YULEX LATEX POWDER-FREE EXAM GLOVES | Yulex Corporation | OIG | Class I | 2008-04-18 |
| K080704 | LOW FLUID ALARM | Em-Tec GmbH | FLN | Class II | 2008-04-17 |
| K072614 | MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE | Matang Mfg. Sdn. Bhd. | LYY | Class I | 2008-04-15 |
| K072598 | IRSG I-MOVER FOR BEDS | International Retail Services Group, LLC | FPO | Class II | 2008-04-14 |
| K073520 | ANGIOTECH CVC | Angiotech Pharmaceuticals, Inc. | FOZ | Class II | 2008-04-11 |
| K071524 | TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL | Tcm World, Inc. | MQX | Class II | 2008-04-10 |
| K080042 | SPIRUS MEDICAL SURGICAL INSTRUMENT | Spirus Medical, Inc. | KMJ | Class I | 2008-04-03 |
| K070584 | SMART-ROD | Duoject Medical Systems, Inc. | LHI | Class II | 2008-04-02 |
| K071517 | AP MEDICAL SHARPS CONTAINERS 0,6-12 LT. | A.B.M. Italia S.P.A | MMK | Class II | 2008-04-02 |
| K080593 | FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116 | Taidoc Technology Corporation | FLL | Class II | 2008-04-02 |
| K072185 | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 | Airistar Technologies, LLC | FRF | Class II | 2008-03-27 |
| K072400 | NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES | Sgmp Co., Ltd. | LZA | Class I | 2008-03-27 |
| K072403 | NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) | Sgmp Co., Ltd. | LYY | Class I | 2008-03-27 |
| K073705 | MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE | Shandong Qiaopai Group Co., Ltd. | FMI | Class II | 2008-03-24 |
| K072739 | JIERUI SYRINGES AND NEEDLES | Shandong Weigao Group Medical Polymer Co., Ltd. | MEG | Class II | 2008-03-21 |
| K072406 | NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) | Sgmp Co., Ltd. | LYY | Class I | 2008-03-21 |
| K073363 | THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 | Paladin Biomedical Corporation | LGZ | Class II | 2008-03-20 |
| K073538 | DUAL CHAMBER TPN CONTAINER | B.Braun Medical, Inc. | KPE | Class II | 2008-03-12 |
| K072197 | POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR | Metacure Surgical Gloves Sdn Bhd | LZC | Class I | 2008-03-12 |
| K073476 | COMPACT AUTO-SAFETY INJECTOR (CASI) | Medical House (Asi) Limited | KZH | Class II | 2008-03-07 |
| K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR | Smiths Medical MD, Inc. | MEA | Class II | 2008-03-07 |
| K072481 | JET PORT PLUS HP CATHETER SYSTEM | Pfm Medical, Inc. | LJT | Class II | 2008-03-07 |
| K080066 | VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) | Gx Corporation Sdn Bhd | LZA | Class I | 2008-03-05 |
| K073299 | BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE | Betel Care Sdn. Bhd. | LYY | Class I | 2008-03-05 |
| K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR | Fenwal, Inc. | BRZ | Class II | 2008-03-03 |
| K072802 | SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE | Ultrawin Sdn Bhd | LYY | Class I | 2008-02-29 |
| K072211 | INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS | Intuitive Surgical, Inc. | KCT | Class II | 2008-02-28 |
| K072145 | MEDICAL GLOVE SERIES | Zhanjiang Jiali Glove Products Co., Ltd. | LYY | Class I | 2008-02-26 |
| K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER | Neomed, Inc. | FOS | Class II | 2008-02-22 |
| K072223 | VINYL EXAMINATION GLOVE, POWDERED | Pinnacle Co., Ltd. | LYZ | Class I | 2008-02-21 |
| K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | Advanced Infusion, Inc. | MEB | Class II | 2008-02-19 |
| K072227 | VINYL EXAMINATION GLOVE POWDER FREE | Pinnacle Co., Ltd. | LYZ | Class I | 2008-02-15 |
| K072955 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) | Smiths Medical MD, Inc. | MRZ | Class II | 2008-02-13 |
| K072487 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | Pyng Medical Corp. | FMI | Class II | 2008-02-13 |
| K080077 | CLAVE STOPCOCK | Icu Medical, Inc. | FMG | Class II | 2008-02-13 |
| K072563 | MILTEX RIGID CONTAINER SYSTEMS | Miltex, Inc. | KCT | Class II | 2008-02-12 |
| K071307 | INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 | Inviro Medical Devices, Inc. | FMI | Class II | 2008-02-12 |
| K073366 | TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041 | Shenzhen Dongdixin Technology Co., Ltd. | FLL | Class II | 2008-02-08 |
| K072228 | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) | Pinnacle Co., Ltd. | LYZ | Class I | 2008-02-08 |
| K073188 | HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE | Smiths Medical Asd, Inc. | FMI | Class II | 2008-02-08 |
| K073241 | VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM | Vascular Pathways | FOZ | Class II | 2008-02-08 |
| K073663 | GELSPRAY WOUND DRESSING | Biocure, Inc. | KMF | Class I | 2008-01-30 |
| K073050 | SAFESTEP MAX POWER-INJECTABLE INFUSION SET | Specialized Health Products International, Inc. | FPA | Class II | 2008-01-25 |
| K073257 | KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR | Kawasumi Laboratories, Inc. | FMI | Class II | 2008-01-25 |
| K073683 | VERIFY CHALLENGE PACKS - VERSION 2 | STERIS Corporation | JOJ | Class II | 2008-01-25 |
| K072635 | CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1 | Ningbo Huahui Medical Instruments Co., Ltd. | FLL | Class II | 2008-01-17 |
15,723 clearances in the General Hospital panel. Data: openFDA.