meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
26
Latest Decision
2010-07-02

Clearances · page 40 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K100979 NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE Jiangsu Sunshine Plastic Products, Co., Ltd. LZA Class I 2010-07-02
K093189 ACTIPROTECT UC N95 RESPIRATOR Glaxosmithkline Consumer Healthcare ORW Class II 2010-07-02
K101293 POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) Pt. Smartglove Indonesia LZA Class I 2010-07-01
K101135 POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK) Hongze Plastic Technology Co., Ltd. LYZ Class I 2010-07-01
K100059 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) Tangshan Zhongpu Plastic Products Co., Ltd. LYZ Class I 2010-07-01
K101580 NEV'S INK AUTOCLAVE TAPES Nev'S Ink, Inc. JOJ Class II 2010-07-01
K101132 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) Hong DI Plastic Products Co., Ltd. LYZ Class I 2010-07-01
K093517 NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE Summit Glove, Inc. LZA Class I 2010-06-29
K093516 NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES Summit Glove, Inc. LZA Class I 2010-06-29
K101253 RII INFRARED EAR THERMOMETER, MODEL: TH60N Radiant Innovation, Inc. FLL Class II 2010-06-29
K100947 FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 Calibra Medical, Inc. OPP Class II 2010-06-28
K100694 COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN Tekmedic (M) Sdn Bhd LYY Class I 2010-06-25
K100665 MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX Needle Tech Products, Inc. FMF Class II 2010-06-24
K100798 MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C Medrad, Inc. FRN Class II 2010-06-23
K101137 POWDER FREE VINYL PATIENT EXAMINATION GLOVE Hongze Plastic Technology Co., Ltd. LYZ Class I 2010-06-22
K101385 DUAL LUER LOCK CAP, MODEL 2C6250 Baxter Healthcare Corp FPA Class II 2010-06-22
K092874 POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES Quality Gallant Sdn. Bhd. LZA Class I 2010-06-22
K100495 PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 Philips Electronics UK Limited FLL Class II 2010-06-22
K092938 HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 App Pharmaceuticals, LLC NZW Class II 2010-06-18
K093335 LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) La Glove (M) Sdn. Bhd. LZA Class I 2010-06-18
K093109 NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') Novo Nordisk, Inc. FMI Class II 2010-06-18
K101017 ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS AngioDynamics, Inc. LJT Class II 2010-06-17
K101362 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) Hebei Handform Plastic Products Co., Ltd. LYZ Class I 2010-06-17
K093800 ROBINSON MEDSURG QUICKSCREW RACK Robinson Medsurg, LLC KCT Class II 2010-06-16
K101341 POWDERED VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Universal Channel Plastic Co., Ltd. LYZ Class I 2010-06-14
K100754 GRAFT DELIVERY SYSTEM MODEL SA-6115 Micromedics, Inc. FMF Class II 2010-06-09
K093193 LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) La Glove (M) Sdn. Bhd. LYY Class I 2010-06-08
K100812 ULTICARE DISPOSABLE PEN NEEDLES Ultimed, Inc. FMI Class II 2010-06-03
K100775 BD INTIMA II CLOSED IV CATHETER Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 2010-06-03
K100563 GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA Geon Corporation FLL Class II 2010-06-02
K090386 NON-INVASIVE INFRARED (NIR) Medisim, Ltd. FLL Class II 2010-05-28
K093264 VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED Qingdao Lang Hui Import & Export Co., Ltd. LYZ Class I 2010-05-28
K100942 U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118 Taidoc Technology Corporation FLL Class II 2010-05-26
K100699 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Star Plastic Co., Ltd. LYZ Class I 2010-05-20
K092617 ROYAL GUARD Shun Thai Rubber Gloves Industry Public Co., Ltd. LZA Class I 2010-05-20
K100369 POWDER-FREE NITRILE GLOVES, BLACK Hl Rubber Industries Sdn Bhd LZA Class I 2010-05-20
K100856 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Suzhou Shengyuda Plastic Products Co., Ltd. LYZ Class I 2010-05-19
K100734 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Huanfu Plastic Products Limited LYZ Class I 2010-05-18
K100735 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Rayu Plastic Products Limited LYZ Class I 2010-05-18
K100953 MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1 Microlife Intellectual Property GmbH FLL Class II 2010-05-17
K100704 ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE Disetronic Medical Systems AG FRN Class II 2010-05-14
K093794 SMART-READ EZTEST-STEAM SCBI AND TEST PACK Sgm Biotech, Inc. FRC Class II 2010-05-14
K100294 SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Yinghao Medical Products Co., Ltd. LYZ Class I 2010-05-14
K100697 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shijiazhuang Universal Channel Plastic Co., Ltd. LYZ Class I 2010-05-13
K100211 PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA Shen Wei (Usa), Inc. LYY Class I 2010-05-11
K093649 AESCULAP STERILCONTAINER S Aesculap FRG Class II 2010-05-11
K093863 EPIDRUM Exmoor Plastics , Ltd. FMF Class II 2010-05-10
K091336 IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V Enthermics Medical Systems, Inc. LGZ Class II 2010-05-07
K100974 SPECTRUM TURBO-JECT PICC SET Cook Incorporated FOZ Class II 2010-05-06
K100486 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR Zibo Yinghao Medical Products Co., Ltd. LYZ Class I 2010-05-05
K092302 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR Bettercare Plastic Products Co., Ltd. LYZ Class I 2010-05-05
K100436 CLICKFINE PEN NEEDLE Ypsomed AG FMI Class II 2010-04-30
K100733 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Rayen Safety Products Limited LYZ Class I 2010-04-30
K093263 STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE Qingdao Lang Hui Import & Export Co., Ltd. LYZ Class I 2010-04-30
K092382 NEXUS PRESSURE RATED EXTENSION SETS Nexus Medical, LLC FPA Class II 2010-04-26
K093618 BILI-MIRROR MODEL BLM-1 Physician Engineered Products, Inc. LBI Class II 2010-04-23
K090882 FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE Hospira, Inc. NGT Class II 2010-04-23
K100855 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Suzhou Shengyuda Plastic Products Co., Ltd. LYZ Class I 2010-04-22
K092240 ACUPUNCTURE NEEDLES Haenglim Seowon Medical Co. MQX Class II 2010-04-21
K100005 BD PEN NEEDLE Becton, Dickinson and Co. FMI Class II 2010-04-15
K092472 NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT Ascend Eagle, Inc. LZA Class I 2010-04-15
K100392 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Jiaxing Plastic Products Co., LT LYZ Class I 2010-04-13
K091022 MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT STERIS Corporation MED Class II 2010-04-12
K091720 SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM Sklar Corp. KCT Class II 2010-04-09
K093229 CATHETER CONNECTIONS DUALCAP Catheter Connections, Inc. QBP Class II 2010-04-08
K091772 POWDER-FREE VINYL EXAM GLOVES Shijiazhuang Huijingyuan Plastic Co, Ltd. LYZ Class I 2010-04-08
K091770 VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR Shijiazhuang Huijingyuan Plastic Co, Ltd. LYZ Class I 2010-04-06
K093176 MED-LOK Sta-Med, LLC MEG Class II 2010-04-06
K100419 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Tangshan Yongkang Glove Co., Ltd. LYZ Class I 2010-04-06
K090036 SYSTEM 1.5 STERILE PROCESSING SYSTEM STERIS Corporation MED Class II 2010-04-05
K093333 PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 Primus Sterilizer Company, LLC FLE Class II 2010-04-02
K093400 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 Unilife Medical Solutions Limited FMF Class II 2010-04-01
K100324 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Hengtong Plastic Products Co. LYZ Class I 2010-03-29
K100337 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Qixin Glove Co., Ltd. LYZ Class I 2010-03-29
K093406 MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 AngioDynamics, Inc. LJS Class II 2010-03-25
K092437 CODMAN STERILIZATION CONTAINERS Codman & Shurtleff, Inc. KCT Class II 2010-03-25
K091890 EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT Healthpoint, Ltd. MED Class II 2010-03-24
K100326 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Hongda Plastci Products Co, Ltd. LYZ Class I 2010-03-24
K100162 MULTIPLE PRIVATE LABEL Biogreen Yields Sdn.Bhd LZA Class I 2010-03-24
K100339 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Changrong Glove Co., Ltd. LYZ Class I 2010-03-22
K092944 DANA REUSABLE TEST PACK FOR STEAM STERILIZATION Dana Products, Inc. FRC Class II 2010-03-18
K100226 WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H) Rio Flexon Technology Co., Ltd. FLL Class II 2010-03-18
K093795 ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010 Actherm, Inc. FLL Class II 2010-03-12
K091722 COAXIAL APPLICATOR SYSTEM Biomet, Inc. FMF Class II 2010-03-12
K093773 AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS Amsino International, Inc. FPA Class II 2010-03-10
K092930 NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED Nexus Medical, LLC FPA Class II 2010-03-10
K092414 CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM Conmed Corporation KCT Class II 2010-03-10
K092908 NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO Neomed, Inc. FMF Class II 2010-03-10
K100058 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) Tangshan Zhongpu Plastic Products Co., Ltd. LYZ Class I 2010-03-05
K093523 MICRO-TOUCH NITRILE Ansell Healthcare Products, LLC LZA Class I 2010-03-04
K092366 TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE Thermal Therapeutic Systems, Inc. LGZ Class II 2010-03-04
K100016 AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 Avita Corporation FLL Class II 2010-03-04
K092905 AUTOSTART BURETTE Analytica Pty, Ltd. FPA Class II 2010-03-04
K093576 RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR Jiangsu Cureguard Glove Co., Ltd. LYZ Class I 2010-03-04
K093414 PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS Smiths Medical Asd, Inc. LJT Class II 2010-03-01
K100282 TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER Terumo Corp. FOZ Class II 2010-02-26
K100075 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) Tangshan Jiteng Plastic Products Co., Ltd. LYZ Class I 2010-02-26
K100074 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) Tangshan Jiteng Plastic Products Co., Ltd. LYZ Class I 2010-02-26
K090068 STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS Case Medical, Inc. FRG Class II 2010-02-24
K093798 POWDER FREE VINYL PATIENT EXAMINATION GLOVE Supermax Plastic Products Co., Ltd. LYZ Class I 2010-02-23

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