Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 33
- Latest Decision
- 2008-12-17
Clearances · page 44 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K082481 | FLOWPICC CATHETER | Vasonova, Inc. | LJS | Class II | 2008-12-17 |
| K081412 | PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | Hospira, Inc. | FRN | Class II | 2008-12-17 |
| K081788 | INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 | Innochips Technology Co., Ltd. | FLL | Class II | 2008-12-17 |
| K082590 | SYMPHONY METER REMOTE | Lifescan, Inc. | LZG | Class II | 2008-12-17 |
| K083129 | SHARPS COMPLIANCE CONTAINER | Sharps Compliance, Inc. | MMK | Class II | 2008-12-15 |
| K081972 | BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES | Nitritex (M) Sdn. Bhd. | LZA | Class I | 2008-12-11 |
| K083299 | TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER | Taidoc Technology Corporation | FLL | Class II | 2008-12-10 |
| K082448 | DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED | Rich Mountain Medical Products, Inc. | LYZ | Class I | 2008-12-10 |
| K082302 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM | Pt. Medisafe Technologies | LZA | Class I | 2008-12-09 |
| K083472 | MEDEGEN PRESSURE RATED EXTENSION SETS | Medegen, Inc. | FPA | Class II | 2008-12-09 |
| K080558 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | Case Medical, Inc. | FRG | Class II | 2008-12-05 |
| K083454 | NUOVOCATH | U.S. Safety Syringes Co., Inc. | FOZ | Class II | 2008-12-04 |
| K081592 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | Quality Gallant Sdn. Bhd. | LZA | Class I | 2008-12-03 |
| K082674 | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE | Spectra Medical Devices, Inc. | FMF | Class II | 2008-11-28 |
| K082125 | N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT | Best Glove, Inc. | LZA | Class I | 2008-11-21 |
| K083189 | STERI-LUB LUBRICATION GEL | Avail Medical Products, Inc. | KMJ | Class I | 2008-11-21 |
| K081123 | NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS | Nexus Medical, LLC | FPA | Class II | 2008-11-14 |
| K082126 | RHAPSODY MRI | Grantadler Corporation | LJT | Class II | 2008-11-13 |
| K081889 | RHAPSODY CT | Grantadler Corporation | LJT | Class II | 2008-11-12 |
| K080976 | NEXUS I.V. FLUID TRANSFER DEVICE | Nexus Medical, LLC | LHI | Class II | 2008-11-10 |
| K082457 | MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) | Ansell Healthcare Products, Inc. | LZA | Class I | 2008-11-10 |
| K082454 | MICROMYST APPLICATOR, MODEL 20-5000 | Covidien | FMF | Class II | 2008-11-07 |
| K081062 | AIRSONNETT AIRSHOWER AIR 3 | Airsonett, Inc. | FRF | Class II | 2008-11-07 |
| K082266 | DIGITAL CLINICAL THERMOMETER MODEL V9XX | Amperor-Electronic(Sz) Co., Ltd. | FLL | Class II | 2008-11-07 |
| K081420 | VANISHPOINT I.V. CATHETER | Retractable Technologies, Inc. | FOZ | Class II | 2008-11-07 |
| K082595 | MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE | Roche Diagnostics | LZG | Class II | 2008-10-28 |
| K082597 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | Tangshan Linyuan Plastic Products Co., Ltd. | LYZ | Class I | 2008-10-24 |
| K072603 | ABC SYRINGE INFUSION PUMP, MODEL 4100 | Elixir Corporation | FRN | Class II | 2008-10-23 |
| K082820 | K-PACK II NEEDLE - 29G THIN WALL | Terumo Europe N.V. | FMI | Class II | 2008-10-23 |
| K083019 | GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE | Hospira, Inc. | FRN | Class II | 2008-10-22 |
| K081436 | INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES | Inviro Medical Devices, Inc. | FMF | Class II | 2008-10-22 |
| K082822 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Zibo Zhuangyuan Plastic Products Company | LYZ | Class I | 2008-10-22 |
| K080466 | ALCOHOL PAD | 122 Corporation | QBP | Class II | 2008-10-21 |
| K081210 | NIPRO SAFETOUCH HUBER INFUSTION SET | Nipro Medical Corp. | FPA | Class II | 2008-10-21 |
| K080877 | 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2 | Unilife Medical Solutions Limited | MEG | Class II | 2008-10-21 |
| K081594 | MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE | Medline Industries, Inc. | LZA | Class I | 2008-10-17 |
| K082370 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | Smart Glove Corp. Sdn Bhd | LZA | Class I | 2008-10-17 |
| K080793 | FIRMGRIP | Flexicath , Ltd. | FOZ | Class II | 2008-10-16 |
| K082447 | DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE | Rich Mountain Medical Products, Inc. | LYZ | Class I | 2008-10-14 |
| K082703 | MRDH BANDAGE | Marine Polymer Technologies, Inc. | KMF | Class I | 2008-10-14 |
| K082217 | RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM | Arizant Healthcare, Inc. | LGZ | Class II | 2008-10-06 |
| K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Elcam Medical Acal | FMG | Class II | 2008-10-02 |
| K082587 | AUTO-SAFETY INJECTOR-2 (ASI-2) | Medical House Products Limited | KZH | Class II | 2008-10-02 |
| K081658 | POWDER-FREE VINYL EXAMINATION GLOVES | Jiangsu Alfa Glove Co., Ltd. | LYZ | Class I | 2008-09-30 |
| K082444 | DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED | Rich Mountain Medical Products, Inc. | LYZ | Class I | 2008-09-30 |
| K082047 | SECURACATH CATHETER, MODEL SPK01 | Interrad Medical, Inc. | OKC | Class II | 2008-09-30 |
| K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT | Cook Vascular, Inc. | LJT | Class II | 2008-09-30 |
| K082752 | QUICKPIN | Laboratorios Grifols, S.A. | LHI | Class II | 2008-09-29 |
| K082443 | DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE | Rich Mountain Medical Products, Inc. | LYZ | Class I | 2008-09-26 |
| K081539 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR | Rich Mountain Medical Products, Inc. | LYZ | Class I | 2008-09-26 |
| K082029 | SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE | Ever Light Plastic Products Co., Ltd. | LYZ | Class I | 2008-09-26 |
| K082616 | HASELMEIER PEN 8 | Haselmeier GmbH | FMF | Class II | 2008-09-26 |
| K082352 | SERIM DISINTEK OPA TEST STRIP | Serim Research Corp. | JOJ | Class II | 2008-09-25 |
| K081472 | SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS | AngioDynamics, Inc. | LJT | Class II | 2008-09-23 |
| K081904 | PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) | Medcomp | LJS | Class II | 2008-09-23 |
| K082362 | SURSHIELD SAFETY I.V. CATHETER | Terumo Medical Corp. | FOZ | Class II | 2008-09-17 |
| K082192 | INFRARED EAR THERMOMETER, MODEL ET-101A | Sejoy Electronics & Instruments Co., Ltd. | FLL | Class II | 2008-09-17 |
| K081910 | NON-STERILE, POWDERED LATEX EXAMINATION GLOVE | Siam Sempermed Corp., Ltd. | LYY | Class I | 2008-09-17 |
| K081569 | DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS | Dynarex Corporation | LZA | Class I | 2008-09-12 |
| K080579 | EFFECTIV (TM) CAP | Hospira, Inc. | QBP | Class II | 2008-09-11 |
| K071783 | VERSAPOD (TM) INSTRUMENT TRAYS | Containmed, Inc. | KCT | Class II | 2008-09-09 |
| K081241 | WEIGAO EMPTY CARTRIDGE SYRINGE | Shandong Weigao Group Medical Polymer Co., Ltd. | FMF | Class II | 2008-09-08 |
| K081547 | BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC | Bio-Med USA, Inc. | FMF | Class II | 2008-09-08 |
| K080531 | CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY | Conmed Linvatec | KCT | Class II | 2008-09-05 |
| K081907 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) | Siam Sempermed Corp., Ltd. | LYY | Class I | 2008-09-03 |
| K082042 | GONGDONG DISPOSABLE SHARP CONTAINER | Zhejiang Gongdong Medical Plastic Factory | MMK | Class II | 2008-09-03 |
| K081821 | D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) | Global Pathogen Solutions, Inc. | MMK | Class II | 2008-09-02 |
| K080420 | RESERT XL HLD HIGH LEVEL DISINFECTANT | STERIS Corporation | MED | Class II | 2008-09-02 |
| K081361 | CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX | Icu Medical, Inc. | FPA | Class II | 2008-08-28 |
| K081488 | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | Pt. Maja Agung Latexindo | LYY | Class I | 2008-08-28 |
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | Tri-State Hospital Supply Corp. | FMQ | Class I | 2008-08-28 |
| K081464 | STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES | Cardinalhealth | LYY | Class I | 2008-08-28 |
| K082306 | POWERLOC CLEAR SAFETY INFUSION SET | C.R. Bard, Inc. | FPA | Class II | 2008-08-28 |
| K081600 | STERIS RESERT XL TEST STRIP | STERIS Corporation | JOJ | Class II | 2008-08-22 |
| K081657 | POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) | Jiangsu Cureguard Glove Co., Ltd. | LYZ | Class I | 2008-08-20 |
| K073444 | TRITON MEIDCAL TMED IV-SET | Triton Medical, LLC | FPA | Class II | 2008-08-18 |
| K082182 | AP 34 MULTI-THERAPY INFUSION PUMP | Q-Core, Ltd. | FRN | Class II | 2008-08-15 |
| K080136 | INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 | Steritec Products, Inc. | JOJ | Class II | 2008-08-15 |
| K081535 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Rich Mountain Medical Products, Inc. | LYZ | Class I | 2008-08-14 |
| K080544 | UNASSIGNED | Medcomp | FPA | Class II | 2008-08-14 |
| K081445 | FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B | Taidoc Technology Corporation | FLL | Class II | 2008-08-11 |
| K081315 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) | Gx Corporation Sdn Bhd | LZA | Class I | 2008-08-11 |
| K080606 | ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE | Alatech Healthcare, LLC | LYY | Class I | 2008-08-07 |
| K073396 | ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG | B.Braun Medical, Inc. | FPA | Class II | 2008-08-07 |
| K080303 | EZ REGULAR | Meinntech Co., Ltd. | FPA | Class II | 2008-08-05 |
| K081289 | V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE | Baxter Healthcare Corp | FPA | Class II | 2008-08-04 |
| K081113 | COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS | Cook, Inc. | FOZ | Class II | 2008-07-30 |
| K081879 | SPSMEDICAL SPORVIEW PA CULTURE SET | Spsmedical Supply Corp. | MRB | Class II | 2008-07-30 |
| K081466 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Smart Glove Corp. Sdn Bhd | LZA | Class I | 2008-07-30 |
| K081524 | SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L | Spectra Medical Devices, Inc. | FMF | Class II | 2008-07-29 |
| K081718 | EXPRESS CHEST DRAIN | Atrium Medical Corp. | KDQ | Class II | 2008-07-25 |
| K081655 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) | Jiangsu Cureguard Glove Co., Ltd. | LYZ | Class I | 2008-07-21 |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | Neomed, Inc. | FOS | Class II | 2008-07-21 |
| K081156 | CADD MEDICATION CASSETTE RESERVOIR | Smiths Medical MD, Inc. | FPA | Class II | 2008-07-18 |
| K081061 | HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES | Harvard Medical Devices , Ltd. | FLL | Class II | 2008-07-18 |
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Westmed, Inc. | MEB | Class II | 2008-07-15 |
| K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM | Kimberly-Clark Corp. | LZC | Class I | 2008-07-14 |
| K081690 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | Cook, Inc. | FOZ | Class II | 2008-07-14 |
| K081370 | SERIM DISINTEK OPA TEST STRIP | Serim Research Corp. | JOJ | Class II | 2008-07-11 |
| K081260 | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES | Kimberly-Clark Corp. | LZA | Class I | 2008-07-09 |
15,723 clearances in the General Hospital panel. Data: openFDA.