Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 34
- Latest Decision
- 2007-08-20
Clearances · page 47 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K071361 | R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 | R4 Vascular, Inc. | LJS | Class II | 2007-08-20 |
| K070002 | BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER | Boston Scientific | LJS | Class II | 2007-08-17 |
| K070020 | COMCASET-P SAFETY IV CATHETER | Pitango Medical, Ltd. | FOZ | Class II | 2007-08-16 |
| K071459 | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES | B.Braun Medical, Inc. | FMF | Class II | 2007-08-16 |
| K071126 | CRYOSEAL FS APPLICATOR SYSTEM | Thermogenesis Corp. | FMF | Class II | 2007-08-16 |
| K063759 | HEATMARKER TIME TEMPERATURE INDICATOR | Temptime Corporation | OCI | Class II | 2007-08-15 |
| K072001 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | Tangshan Hongyun Plastic Products Co., Ltd. | LYZ | Class I | 2007-08-15 |
| K070911 | STD MED PRIMO PORT | Std Med, Inc. | LJT | Class II | 2007-08-10 |
| K072037 | CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML | Life-Shield Products, Inc. | MEG | Class II | 2007-08-08 |
| K071207 | MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES | High Momentum Sdn Bhd | LZA | Class I | 2007-08-07 |
| K071828 | LULLABY | Ge Healthcare Clinical Systems | LBI | Class II | 2007-08-06 |
| K070117 | SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC | Dolomite Biotech Sdn Bhd | MEG | Class II | 2007-08-06 |
| K071685 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Langfang Huilong Plastic Product Co., Ltd. | LYZ | Class I | 2007-08-06 |
| K070163 | SWABBABLE CAP, MODEL 60205 | Baxa Corp. | ODI | Class II | 2007-08-03 |
| K071785 | HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE | Smiths Medical Asd, Inc. | FMI | Class II | 2007-08-02 |
| K070627 | OPACIDEN SOLUTION | Ciden Technologies, LLC | MED | Class II | 2007-08-02 |
| K070451 | ABLE CENTRAL VENOUS CATHETER | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | FOZ | Class II | 2007-07-31 |
| K071123 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR | Xuzhou Full Sun Medical Products , Ltd. | LYZ | Class I | 2007-07-30 |
| K071208 | MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES | High Momentum Sdn Bhd | LZA | Class I | 2007-07-30 |
| K071060 | NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) | Sgmp Co., Ltd. | LYY | Class I | 2007-07-26 |
| K071209 | MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES | High Momentum Sdn Bhd | LYY | Class I | 2007-07-25 |
| K071119 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) | Gx Corporation Sdn Bhd | LZA | Class I | 2007-07-24 |
| K071027 | TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE | Tribofilm Research, Inc. | FMF | Class II | 2007-07-20 |
| K071735 | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | MEB | Class II | 2007-07-19 |
| K070461 | VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 | STERIS Corporation | JOJ | Class II | 2007-07-17 |
| K071175 | OHMEDA MEDICAL GIRAFFE OMNIBED | GE Healthcare | FMZ | Class II | 2007-07-17 |
| K070428 | MEDICOM SELF-SEALING STERILIZATION POUCH | A.R. Medicom, Inc. | KCT | Class II | 2007-07-17 |
| K070936 | WELMED HYPODERMIC SYRINGE | Welmed, Inc. | FMF | Class II | 2007-07-16 |
| K070577 | ON THE GO SHARPS | Medport, Inc. | MMK | Class II | 2007-07-13 |
| K070852 | VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR | Shijiazhang Hongxiang Plastic Products Co., Ltd. | LYZ | Class I | 2007-07-13 |
| K071322 | POWDER FREE LATEX EXAMINATION GLOVES | Quality Gallant Sdn. Bhd. | LYY | Class I | 2007-07-13 |
| K070377 | GIRAFFE AND PANDA WARMER | Ohmeda Medical | FMT | Class II | 2007-07-11 |
| K071630 | TERUMO 31G THINPRO INSULIN SYRINGE | Terumo Medical Corp. | FMF | Class II | 2007-07-11 |
| K070578 | CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER | Zen Strong Medical Technology Co., Ltd. | FLL | Class II | 2007-07-11 |
| K071088 | LIFE LATCH SHARPS & BIOHAZARD CONTAINER | M&M Industries, Inc. | FMI | Class II | 2007-07-05 |
| K071022 | POWDER-FREE VINYL EXAMINATION GLOVES | Glormed Colombia S.A. | LYZ | Class I | 2007-07-05 |
| K063681 | TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE | Mediline Italia S.R.L. | FLE | Class II | 2007-06-29 |
| K070613 | ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT | AngioDynamics, Inc. | LJS | Class II | 2007-06-29 |
| K071323 | POWDERED LATEX EXAMINATION GLOVES | Quality Gallant Sdn. Bhd. | LYY | Class I | 2007-06-22 |
| K070491 | DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 | K-Jump Health Co., Ltd. | FLL | Class II | 2007-06-21 |
| K070917 | FEEL-JECT INSULIN SYRINGE | Feel Tech | FMF | Class II | 2007-06-20 |
| K070639 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING | Siam Sempermed Corp., Ltd. | LZA | Class I | 2007-06-15 |
| DEN060002 | INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM | Inrange Systems, Inc. | NZH | Class II | 2007-06-13 |
| K062704 | STERILIZATION POUCH WITH INDICATORS | Winner Industries (Shenzhen) Co., Ltd. | FRG | Class II | 2007-06-08 |
| K070654 | HYPERTHERMIA PUMP | Belmont Instrument Corp. | LGZ | Class II | 2007-06-08 |
| K070760 | POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE | Derma Care Plus Products, LLC | LYY | Class I | 2007-06-07 |
| K070633 | GENIE, MODEL CH-200 | Icu Medical, Inc. | FMF | Class II | 2007-06-05 |
| K070878 | DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 | Rg Medical Diagnostics | FLL | Class II | 2007-06-05 |
| K070862 | POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE) | Purtech Cleanroom Products Co., Ltd. | LZA | Class I | 2007-05-30 |
| K070814 | MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP | Confluent Surgical,Inc | FMF | Class II | 2007-05-30 |
| K070264 | 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB | Terumo Europe N.V. | FMF | Class II | 2007-05-29 |
| K070575 | EVICEL APPLICATION DEVICE | Omrix Biopharmaceuticals , Ltd. | FMF | Class II | 2007-05-29 |
| K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corp | MEB | Class II | 2007-05-25 |
| K070547 | SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) | Terumo Europe N.V. | FPA | Class II | 2007-05-25 |
| K070801 | IMM HYPODERMIC NEEDLE SET | Innovative Medical Manufacturing Co. | FPA | Class II | 2007-05-24 |
| K071108 | TEXIUM SYRINGE | Cardinal Health, Alaris Products | FMF | Class II | 2007-05-24 |
| K071355 | SMARTSPONGE SYSTEM | Clearcount Medical Solutions, Inc. | LWH | Class I | 2007-05-24 |
| K071014 | MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR | Advanced Sterilization Products | FRC | Class II | 2007-05-24 |
| K070595 | SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR | Spsmedical Supply Corp. | FRC | Class II | 2007-05-24 |
| K070116 | POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE | Smiths Medical MD, Inc. | LJT | Class II | 2007-05-23 |
| K070180 | WALLABY 4 | Respironics Inc., Sleep & Home Respiratory Group | LBI | Class II | 2007-05-18 |
| K070235 | BODYGUARD PAIN MANAGER INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | FRN | Class II | 2007-05-18 |
| K070457 | SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB | Sun Scientific, LLC | MHW | Class I | 2007-05-16 |
| K070861 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Hong Xin Rubber Products Co., Ltd. | LZA | Class I | 2007-05-15 |
| K070003 | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) | Medcomp | LJT | Class II | 2007-05-15 |
| K070821 | POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE | Medtexx Manufacturing Sdn. Bhd. | LYY | Class I | 2007-05-10 |
| K070996 | 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER | C.R. Bard, Inc. | LJS | Class II | 2007-05-08 |
| DEN060009 | 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR | 3M Company | NZJ | Class II | 2007-05-08 |
| K070529 | AFF (MARK I) VOLUMETRIC INFUSION PUMP | Definitive Medical Technologies, Ltd. | FRN | Class II | 2007-05-08 |
| K070362 | SURFLO WINGED INFUSION SET | Terumo Europe N.V. | FPA | Class II | 2007-05-07 |
| K063363 | FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE | Flexicath , Ltd. | LJS | Class II | 2007-05-07 |
| K062784 | SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) | Sejoy Electronics & Instruments Co., Ltd. | FLL | Class II | 2007-05-04 |
| K070615 | ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT | AngioDynamics, Inc. | LJS | Class II | 2007-05-04 |
| K063202 | PRODERMA LIQUID BANDAGE | Procurement Technology Systems, LLC | KMF | Class I | 2007-05-02 |
| K071019 | DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES | Mesure Technology Co., Ltd. | FLL | Class II | 2007-04-27 |
| K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 | Hospira, Inc. | FRN | Class II | 2007-04-24 |
| K070203 | INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 | Inviro Medical Devices, Inc. | MEG | Class II | 2007-04-23 |
| K070976 | RII INFRARED EAR THERMOMETER, MODEL TH01BN | Radiant Innovation, Inc. | FLL | Class II | 2007-04-20 |
| K061756 | TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP | Shen Wei (Usa), Inc. | LZA | Class I | 2007-04-19 |
| K070125 | COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION | Baxter Healthcare Corp | FRN | Class II | 2007-04-16 |
| K062526 | BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE | Multisafe Sdn. Bhd. | LYY | Class I | 2007-04-13 |
| K070718 | MODIFICATION TO: BODYGUARD INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | FRN | Class II | 2007-04-13 |
| K063542 | WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F. | Mesure Technology Co., Ltd. | FLL | Class II | 2007-04-10 |
| K070519 | PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES | Zhang Jia Gang Huayuan Plastic Co. , Ltd. | LYZ | Class I | 2007-04-10 |
| K070143 | JMS PLANECTA STOPCOCK | Jms North America Corp. | FMG | Class II | 2007-04-10 |
| K061505 | POWERED NITRILE BLUE EXAMINATION GLOVES | Liwe Trading | LZA | Class I | 2007-04-09 |
| K062261 | FOAM RING PORT PROTECTOR | Inspired Ideas, Incorporated | OBK | Class II | 2007-04-09 |
| K070657 | GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER | Getinge Sourcing, LLC | FLE | Class II | 2007-04-05 |
| K063848 | POWERGROSHONG PICC CATHETER | C.R. Bard, Inc. | LJS | Class II | 2007-04-04 |
| K070430 | PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS | Unomedical A/S | FPA | Class II | 2007-04-04 |
| K063159 | STERILOX LIQUID CHEMICAL STERILANT SYSTEM | Puricore, Inc. | MED | Class II | 2007-04-02 |
| K063674 | EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE | Animas Corp. | LZG | Class II | 2007-03-30 |
| K070041 | POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Lianhe Shunda Plastic Products Co., L | LYZ | Class I | 2007-03-28 |
| K070404 | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES | Tangshan Luxiong Plastic Products Co., Ltd. | LZA | Class I | 2007-03-26 |
| K070097 | POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR | Gx Corporation Sdn Bhd | LZA | Class I | 2007-03-23 |
| K070038 | POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW | Super Safe Plastic Products Co., Ltd. | LYZ | Class I | 2007-03-23 |
| K070027 | POWDERED (WHITE) VINYL PATIENT EXAMINATION | Shijiazhuang Lianhe Shunda Plastic Products Co., L | LYZ | Class I | 2007-03-22 |
| K070100 | HASELMEIER PEN | Haselmeier Sarl | FMF | Class II | 2007-03-21 |
| K063627 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | Smart Glove Corp. Sdn Bhd | LZA | Class I | 2007-03-20 |
| K062919 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) | Shen Wei (Usa), Inc. | LZA | Class I | 2007-03-20 |
15,723 clearances in the General Hospital panel. Data: openFDA.