Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 33
- Latest Decision
- 2008-01-16
Clearances · page 46 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K073206 | NEEDLE-TRAP/NEEDLE SAFETY LABEL | Schreiner Medipharm | MEG | Class II | 2008-01-16 |
| K073451 | PRESSURE INJECTABLE PICC | Arrow International, Inc. | LJS | Class II | 2008-01-15 |
| K072790 | CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008 | Confluent Surgical,Inc | FMF | Class II | 2008-01-11 |
| K071788 | AVIATOR INSULIN PUMP | Abbott Diabetes Care, Inc. | LZG | Class II | 2008-01-11 |
| K072105 | ALARIS SYSTEM WITH MMS, MODEL 8XXX | Cardinal Health 303,Inc. | FRN | Class II | 2007-12-28 |
| K071886 | SELF SEAL STERILIZATION POUCH | Shanghai Jianzhong Medical Packaging Co., Ltd. | FRG | Class II | 2007-12-27 |
| K072518 | CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS) | Crs Medical Diagnostics, Inc. | LJS | Class II | 2007-12-20 |
| K073127 | BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G | Shandong Weigao Group Medical Polymer Co., Ltd. | FMI | Class II | 2007-12-20 |
| K073193 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Prosperous Plastic Co., Ltd. | LYZ | Class I | 2007-12-20 |
| K073423 | MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER | C.R. Bard, Inc. | LJT | Class II | 2007-12-19 |
| K072466 | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 | Scican , Ltd. | FLE | Class II | 2007-12-19 |
| K071537 | STERRAD 100NX TEST PACK | Advanced Sterilization Products | FRC | Class II | 2007-12-18 |
| K071613 | AMIGO INSULIN PUMP | Nipro Diabetes Systems, Inc. | LZG | Class II | 2007-12-14 |
| K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS | Smiths Medical MD, Inc. | LJT | Class II | 2007-12-14 |
| K072654 | PATIENT SAFE SYRINGE | Retractable Technologies, Inc. | FMF | Class II | 2007-12-14 |
| K072377 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR | Xuzhou Full Sun Medical Products , Ltd. | LYZ | Class I | 2007-12-14 |
| K070722 | PLASMAIR, MODEL T2006 | Airinspace B.V. | FRF | Class II | 2007-12-14 |
| K071400 | SMARTSITE STOPCOCK | Cardinal Health, Alaris Products | FMG | Class II | 2007-12-14 |
| K072511 | SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM | Medimop Medical Projects, Ltd. | LHI | Class II | 2007-12-13 |
| K072375 | SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET | AngioDynamics, Inc. | FPA | Class II | 2007-12-13 |
| K072625 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) | Cook, Inc. | LJS | Class II | 2007-12-13 |
| K072759 | VIAL2BAG | Medimop Medical Projects, Ltd. | LHI | Class II | 2007-12-13 |
| K071122 | DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR | Xuzhou Full Sun Medical Products , Ltd. | LYZ | Class I | 2007-12-12 |
| K072314 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR | Xuzhou Full Sun Medical Products , Ltd. | LYZ | Class I | 2007-12-12 |
| K073210 | MODIFICATION TO: T-PORT HP INFUSION PORT | Pfm Medical, Inc. | LJT | Class II | 2007-12-12 |
| K072510 | VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 | STERIS Corporation | JOJ | Class II | 2007-12-11 |
| K072330 | CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM | Biomet, Inc. | FMF | Class II | 2007-12-06 |
| K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 | Vygon Corp. | FOZ | Class II | 2007-11-30 |
| K072482 | HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY | Smiths Medical Asd, Inc. | MEG | Class II | 2007-11-29 |
| K071385 | STERRAD 100NX STERILIZER | Advanced Sterilization Products | MLR | Class II | 2007-11-29 |
| K071588 | DISPENSER DP 20 | NOUVAG AG | FRN | Class II | 2007-11-26 |
| K072921 | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | Symbios Medical Products, LLC | MEB | Class II | 2007-11-26 |
| K072509 | PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY | Medcomp | LJS | Class II | 2007-11-26 |
| K073122 | MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE | Covidien Lp, Formerly Registered AS Tyco Healthcar | FMI | Class II | 2007-11-21 |
| K072391 | PFM PICC | Pfm Medical, Inc. | LJS | Class II | 2007-11-19 |
| K072778 | BRIO ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | MQX | Class II | 2007-11-19 |
| K073180 | SMARTSPONGE PLUS SYSTEM | Clearcount Medical Solutions, Inc. | LWH | Class I | 2007-11-19 |
| K072639 | YUYUAN LATEX EXAMINATION GLOVE, POWDERED | Shandong Yuyuan Latex Gloves Company , Ltd. | LYY | Class I | 2007-11-19 |
| K071895 | VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR | STERIS Corporation | JOJ | Class II | 2007-11-14 |
| K072549 | TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER | C.R. Bard, Inc. | LJT | Class II | 2007-11-14 |
| K072419 | ADVANTIV SAFETY I.V. CATHETER | Smiths Medical Asd, Inc. | FOZ | Class II | 2007-11-09 |
| K072247 | STERICAN HYPODERMIC NEEDLES | B.Braun Medical, Inc. | FMI | Class II | 2007-11-08 |
| K072053 | SMARTBLOCK PAIN PUMP | Medical Flow Systems, Ltd. | MEB | Class II | 2007-11-06 |
| K072576 | CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED | Baxter Healthcare Corp | FPA | Class II | 2007-11-06 |
| K072894 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | Terumo Europe N.V. | FPA | Class II | 2007-11-06 |
| K071875 | V-CATH POLY PICC | Hdc Corp. | LJS | Class II | 2007-11-05 |
| K072641 | DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. | Famidoc Technology Co., Ltd. | FLL | Class II | 2007-11-01 |
| K072059 | GRIPPER MICRO NEEDLE | Smiths Medical MD, Inc. | FMI | Class II | 2007-11-01 |
| K072215 | TITANIUM POWERPORT ISP IMPLANTED PORT | C.R. Bard, Inc. | LJT | Class II | 2007-11-01 |
| K071545 | Z-800 VOLUMETRIC INFUSION PUMP | Zyno Medical, LLC | FRN | Class II | 2007-10-31 |
| K072404 | ERBE ERBEJET 2 SYSTEM | Erbe USA, Inc. | FQH | Class II | 2007-10-31 |
| K072097 | BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 | Medical Select, Inc. | LBI | Class II | 2007-10-30 |
| K072472 | DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED | Xuzhou Full Sun Medical Products , Ltd. | LYZ | Class I | 2007-10-25 |
| K072488 | LANFAN POWDER-FREE VINYL EXAM GLOVES | Shanghai Lanfan Co., Ltd. | LYZ | Class I | 2007-10-19 |
| K071993 | T-PORT HP INFUSION PORT | Pfm Medical, Inc. | LJT | Class II | 2007-10-17 |
| K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 | Medtronic Minimed, Inc. | MRZ | Class II | 2007-10-17 |
| K071087 | VIS-U-ALL II HEAT-SEAL POUCH AND TUBING | STERIS Corporation | FRG | Class II | 2007-10-16 |
| K071382 | SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, | Shinchang Medical Co., Ltd. | FOZ | Class II | 2007-10-16 |
| K072401 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR | Xuzhou Full Sun Medical Products , Ltd. | LYZ | Class I | 2007-10-15 |
| K071947 | VACU-MED BLOOD COLLECTION NEEDLES | Shina Corp. | FMI | Class II | 2007-10-12 |
| K070765 | VIS-U-ALL II SELF SEAL POUCH | STERIS Corporation | KCT | Class II | 2007-10-12 |
| K072667 | SHARPS AWAY DISPOSABLE CONTAINER | Solutions, Inc. | MMK | Class II | 2007-10-10 |
| K070856 | ICU MEDICAL SINGLE-USE SYRINGE | Icu Medical, Inc. | FMF | Class II | 2007-10-05 |
| K072087 | BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 | Belimed Sauter AG | FLE | Class II | 2007-10-05 |
| K072230 | POWERPICC SOLO | C.R. Bard, Inc. | LJS | Class II | 2007-10-05 |
| K070769 | VHP 136 TRAY | STERIS Corporation | KCT | Class II | 2007-10-05 |
| K063631 | POLYPERF / POLYPERF SAFE | Laboratoires Perouse | FPA | Class II | 2007-10-05 |
| K062297 | VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | MLR | Class II | 2007-10-04 |
| K072299 | POWRSYRINGE ASPIRATOR | Pinyons Medical Technology, Inc. | FMF | Class II | 2007-10-04 |
| K071740 | CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES | Medtexx Manufacturing Sdn. Bhd. | LZA | Class I | 2007-10-04 |
| K071421 | PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET | Promepla | FPA | Class II | 2007-10-04 |
| K072512 | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Datex-Ohmeda, Inc. | FMZ | Class II | 2007-10-03 |
| K070339 | DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES | Cincinnati Sub-Zero Products, Inc. | FLL | Class II | 2007-09-26 |
| K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT | Arrow Intl., Inc. | FMI | Class II | 2007-09-26 |
| K072542 | MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR | Medegen Medical Manufacturing System | FPA | Class II | 2007-09-25 |
| K071741 | TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | Migada Plant | LHI | Class II | 2007-09-24 |
| K072345 | POWRSYRINGE MONITOR | Pinyons Medical Technology, Inc. | FMF | Class II | 2007-09-21 |
| K070291 | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX | Medix I.C.S.A. | FMZ | Class II | 2007-09-21 |
| K072318 | POWRSYRINGE INJECTOR | Pinyons Medical Technology, Inc. | FMF | Class II | 2007-09-21 |
| K063048 | TRANS-CATHETER EXTRACTOR | Tran Pa-C, Inc. | ODY | Class II | 2007-09-14 |
| K071170 | POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL | Smart Glove Corp. Sdn Bhd | LZA | Class I | 2007-09-14 |
| K071567 | AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE | Autosafe-Refelx, Inc. | FMI | Class II | 2007-09-14 |
| K072320 | GREINER VACUETTE QUICKSHIELD COMPLETE | Greiner Bio-One North America, Inc. | FMI | Class II | 2007-09-14 |
| K062644 | FLEXWARMER, MODELS KZ-1 AND KZ-2 | Merlyn Associates, Inc. | LGZ | Class II | 2007-09-11 |
| K070590 | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R | Microlife Intellectual Property GmbH | FLL | Class II | 2007-09-11 |
| K071910 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) | Hartalega Sdn Bhd | LZA | Class I | 2007-09-06 |
| K070895 | VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK | STERIS Corporation | JOJ | Class II | 2007-09-05 |
| K072085 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. | LYZ | Class I | 2007-09-04 |
| K071418 | DANA 3CC SYRINGE INSULIN RESERVOIR | Sooil Development Co., Ltd. | MRZ | Class II | 2007-09-04 |
| K070630 | HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE | Health Line International Corporation (Hlic) | FPA | Class II | 2007-08-31 |
| K072108 | MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES | Tecnimed S.R.L. | FLL | Class II | 2007-08-31 |
| K070419 | OPACIDEN OPA REAGENT STRIPS | Hach Company | JOJ | Class II | 2007-08-31 |
| K071846 | MODIFICATION TO EZ HUBER SAFETY INFUSION SET | Pfm Medical, Inc. | FPA | Class II | 2007-08-30 |
| K071072 | SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE | Shanghai China Star Corp | LZA | Class I | 2007-08-30 |
| K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER | Arrow International, Inc. | FOZ | Class II | 2007-08-30 |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Ohmeda Medical | FMT | Class II | 2007-08-27 |
| K072196 | ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT | AngioDynamics, Inc. | LJS | Class II | 2007-08-27 |
| K062865 | SMALL VOLUME SYRINGE | Alcon Laboratories | FMF | Class II | 2007-08-23 |
| K070988 | SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) | Shinchang Medical Co., Ltd. | FMI | Class II | 2007-08-23 |
| K071686 | POWDERED VINYL PATIENT EXAMINATION GLOVES | Langfang Huilong Plastic Product Co., Ltd. | LYZ | Class I | 2007-08-22 |
15,723 clearances in the General Hospital panel. Data: openFDA.