meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
2010-02-23

Clearances · page 41 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K092681 POWDERED LATEX EXAMINATION GLOVES, NON-STERILE Khai Hoan Joint Stock Company LYY Class I 2010-02-23
K092712 SKIN BARRIER FILM Lodestar Products, Inc. KMF Class I 2010-02-23
K093797 POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE) Supermax Plastic Products Co., Ltd. LYZ Class I 2010-02-23
K093726 MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Medline Industries, Inc. LZA Class I 2010-02-22
K091806 POGO SCREW INSTRUMENTATION TRAY Fxdevices KCT Class II 2010-02-22
K100209 BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY Becton, Dickinson & CO FMI Class II 2010-02-19
K093759 MULTIPLE NAME MODEL MULTIPLE Gx Corporation Sdn Bhd (Plant 1) LZA Class I 2010-02-19
K090917 SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM Baxa Corp. LHI Class II 2010-02-19
K093696 SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 Central Medicare Sdn Bhd LZA Class I 2010-02-12
K091210 ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT Best Sanitizers, Inc. MED Class II 2010-02-05
K093927 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER C.R. Bard, Inc. LJS Class II 2010-02-04
K092527 NEXUS INJECTION SITE, MODEL NIS-8 Nexus Medical, LLC FPA Class II 2010-02-04
K092491 MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES Medefil, Inc. NZW Class II 2010-02-03
K093496 NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT Oon Corp. Resources LYY Class I 2010-02-03
K092746 MICRONJET 600 Nanopass Technologies , Ltd. FMI Class II 2010-02-03
K090111 FLEXPEN NEEDLE Novo Nordisk, Inc. FMI Class II 2010-02-01
K093727 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR Zibo Bolin Gloves Co., Ltd. LYZ Class I 2010-02-01
K091583 MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE Medefil, Inc. NGT Class II 2010-01-28
K093182 SET GRI-FILL 3.0 Laboratorios Grifols, S.A. LHI Class II 2010-01-27
K093271 EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD Victus, Inc. FPA Class II 2010-01-27
K093364 SOLO MICROPUMP INSULIN DELIVERY SYSTEM Medingo , Ltd. LZG Class II 2010-01-25
K093065 FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 Calibra Medical, Inc. OPP Class II 2010-01-20
K093500 POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE Wear Safe (Malaysia) Sdn. Bhd. LZC Class I 2010-01-19
K091950 SMART-WELL EZTEST INCUBATOR Sgm Biotech, Inc. FRC Class II 2010-01-15
K092831 DISPOSABLE HYPODERMIC NEEDLE Feel Tech FMI Class II 2010-01-14
K092346 SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 Serim Research Corp. JOJ Class II 2010-01-07
K092447 DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES Hangzhou Hua'An Medical & Health Instruments Co., FLL Class II 2010-01-07
K092172 EXEL I.V. EXTENSION SET Exelint Intl. Co. FPA Class II 2010-01-04
K092906 VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION STERIS Corporation FRC Class II 2009-12-30
K091851 STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Gx Corporation Sdn Bhd LZA Class I 2009-12-28
K090959 LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA D'Antonio Consultants International, Inc. (Dci) KZE Class II 2009-12-24
K093439 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Pufa Plastic Products Co., Ltd. LYZ Class I 2009-12-22
K092823 AMSCO WARMING CABINET STERIS Corporation LGZ Class II 2009-12-18
K093557 SMARTWAND-DTX Clearcount Medical Solutions LWH Class I 2009-12-18
K090921 ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 Beiersdorf, Inc. DWL Class II 2009-12-18
K092488 DYNAREX STERILE LUBRICATING JELLY Dynarex Corporation KMJ Class I 2009-12-18
K093252 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER Footprint Medical, Inc. LJS Class II 2009-12-17
K093546 SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX Togo Medikit Co., Ltd. FOZ Class II 2009-12-17
K092557 DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES Harvard Medical Devices , Ltd. FLL Class II 2009-12-17
K093144 LOUSEBUSTER Larada Sciences LJL Class I 2009-12-16
K092682 GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS Gyrus Acmi, Inc. KCT Class II 2009-12-11
K093332 DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) Delphi Medical Systems FRN Class II 2009-12-09
K092966 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Jin Zhou Chang Hao Plastic Products Co., Ltd. LYZ Class I 2009-12-08
K092782 INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, Carmel Pharma Ab. LHI Class II 2009-12-07
K093570 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR Jiangsu Jaysun Glove Co., Ltd. LYZ Class I 2009-12-04
K093199 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK 3M Company JOJ Class II 2009-12-04
K092956 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shandong Aobo Medical Co, Ltd. LYZ Class I 2009-12-04
K092820 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Fuhao Plastic Products Co., Ltd. LYZ Class I 2009-12-03
K090636 TSO3 OZONE STERILIZER, MODEL 125L Tso3, Inc. FLF Class II 2009-12-02
K093375 KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) Koon Seng Sdn Bhd LYY Class I 2009-12-02
K092958 AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES Avita Corporation FLL Class II 2009-12-02
K093277 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Green Healthcare Co., Ltd. LYZ Class I 2009-11-30
K093272 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Huamei Healthcare Co., Ltd. LYZ Class I 2009-11-30
K092959 AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152 Avita Corporation FLL Class II 2009-11-27
K092160 POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES Comfort Rubber Gloves Ind. Sdn. Bhd. LZA Class I 2009-11-27
K093366 NMI PICC II Navilyst Medical, Inc. LJS Class II 2009-11-24
K093309 PRO-LINE CT (BASIC TRAY) MODEL MR28036101 Medcomp ( Medical Components) LJS Class II 2009-11-24
K091965 POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED Platinum Glove Industries Sdn. Bhd. LZA Class I 2009-11-24
K092499 LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) La Glove (M) Sdn. Bhd. LYY Class I 2009-11-20
K092498 LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) La Glove (M) Sdn. Bhd. LZA Class I 2009-11-20
K092040 PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 R4 Vascular, Inc. LJS Class II 2009-11-18
K091924 VPS CATHETER Vasonova, Inc. LJS Class II 2009-11-18
K092246 NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 Nipro Medical Corporation LHI Class II 2009-11-12
K093270 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Excellence Glove Co., Ltd. LYZ Class I 2009-11-04
K092490 AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 STERIS Corporation FLE Class II 2009-11-04
K092072 POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE Gx Corporation Sdn Bhd LZA Class I 2009-11-04
K092313 PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B.Braun Medical, Inc. MEA Class II 2009-11-04
K093276 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Kangyuan Glove Co., Ltd. LYZ Class I 2009-11-04
K092790 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Boxiang Plastic & Rubber Co., Ltd. LYZ Class I 2009-11-02
K091643 POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Gx Corporation Sdn Bhd LZC Class I 2009-11-02
K092167 KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 Kimberly-Clark Corp. FRG Class II 2009-11-02
K091441 SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET Synergetics, Inc. FRN Class II 2009-10-30
K092318 BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE Baxter Healthcare Corporation LHI Class II 2009-10-30
K091736 SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 Daniels Corporation Pty, Inc. MMK Class II 2009-10-30
K092986 ACACIA PISTON SYRINGE Acacia, Inc. FMF Class II 2009-10-27
K091174 VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL STERIS Corporation JOJ Class II 2009-10-27
K092301 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK) Bettercare Plastic Products Co., Ltd. LYZ Class I 2009-10-22
K091389 EQUALSHIELD LUER LOCK CONNECTOR PAIR Plastmed, Ltd. LHI Class II 2009-10-22
K092296 POWDER FREE EXAMINATION GLOVE Bettercare Plastic Products Co., Ltd. LYZ Class I 2009-10-21
K092294 VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR Bettercare Plastic Products Co., Ltd. LYZ Class I 2009-10-21
K092492 POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O Wear Safe (Malaysia) Sdn. Bhd. LYY Class I 2009-10-21
K082756 RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR Raven Biological Laboratories, Inc. FRC Class II 2009-10-21
K092411 PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) Shen Wei (Usa), Inc. LZA Class I 2009-10-21
K092034 POWDER FREE NITRILE EXAMINATION GLOVES, BLACK Pt. Smartglove Indonesia LZA Class I 2009-10-19
K091471 PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL Cartagloves S.A. LYZ Class I 2009-10-15
K091140 EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO Vidacare Corporation FMI Class II 2009-10-14
K090459 DISPOSABLE TPE INFUSION SET Shan Dong Wei Gao Group Medical Polymer Products FPA Class II 2009-10-13
K091709 MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC Edwards Lifesciences, LLC FOZ Class II 2009-10-13
K090650 SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS Spsmedical Supply Corp. JOJ Class II 2009-10-09
K092109 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Zhangjiangang All Fine Rubber-Plastic Products Co. LYZ Class I 2009-10-09
K090361 REMOTE INFRARED THERMOMETER, MODEL RC002 Rycom Electron Technology Limited FLL Class II 2009-10-08
K092516 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Zi BO Yuxiang Gloves Co., Ltd. LYZ Class I 2009-10-07
K090568 MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN Medline Industries, Inc. LZA Class I 2009-10-02
K092016 SUPER-FINE PEN NEEDLE Stat Medical Devices, Inc. FMI Class II 2009-10-02
K091386 MICROFUSE DUAL RATE INFUSER Numia Medical Technology, LLC FRN Class II 2009-10-02
K090117 AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET Autosafe-Reflex, Inc. FMI Class II 2009-09-29
K092629 SNM FIRMGRIP Flexicath , Ltd. FOZ Class II 2009-09-25
K091213 FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN Footprint Medical FOS Class II 2009-09-25
K082648 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Dar Plastic & Rubber Products Co. , Ltd. LYZ Class I 2009-09-25
K091214 FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER Footprint Medical FOS Class II 2009-09-25

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