meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
40
Latest Decision
2009-05-15

Clearances · page 43 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K090265 BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V Scican , Ltd. FLE Class II 2009-05-15
K083851 INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 Inviro Medical Devices, Inc. LHI Class II 2009-05-15
K091040 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 Microlife Intellectual Property GmbH FLL Class II 2009-05-13
K091261 NMI PICC Navilyst Medical, Inc. LJS Class II 2009-05-12
K091042 CRONO S-PID 50 Cane S.R.L. FRN Class II 2009-05-12
K083156 NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE Giga-Drive Sdn, Bhd LZA Class I 2009-05-08
K090513 VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) Shandong Huayue Glove Co., Ltd. LYZ Class I 2009-05-08
K090691 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shijiazhuang Benestar Plastic Co., Ltd. LYZ Class I 2009-05-07
K090157 ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5. Wcm Waste & Compliance Management, Inc. MMK Class II 2009-05-04
K090371 VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM STERIS Corporation KCT Class II 2009-05-01
K090973 TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) Terumo Corp. FOZ Class II 2009-05-01
K082554 KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 Kimberly-Clark Corp. FRG Class II 2009-05-01
K083920 FLOWPICC CATHETER Vasonova, Inc. LJS Class II 2009-05-01
K090300 MODIFICATION TO AUTOFUSER Ace Medical Us, LLC MEB Class II 2009-04-30
K090569 MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 3M Company FRC Class II 2009-04-29
K090809 MPS ACACIA POWER INJECTABLE INFUSION SET Mps Acacia FPA Class II 2009-04-28
K083508 SWABCAP Excelsior Medical Corp. QBP Class II 2009-04-28
K083931 SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE Quantum Co., Ltd. LYZ Class I 2009-04-27
K090905 ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE B.Braun Medical, Inc. LHI Class II 2009-04-27
K090138 MOBILECARE MONITOR, MODEL 2100 Aframe Digital, Inc. KMI Class I 2009-04-24
K082908 NOVAGUARD, MODEL 3611001 West Pharmaceutical Services, Inc. FMI Class II 2009-04-24
K090192 BILI BLUE F20T12/BBY AND F40T12/BBY Interlectric Corp. LBI Class II 2009-04-24
K090464 BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE Pt Mahakarya Inti Buana LZA Class I 2009-04-23
K090134 INTRAVENOUS POWER INJECTOR EXTENSION SET C.R. Bard, Inc. FPA Class II 2009-04-21
K090697 MODIFICATION TO: GIRAFFE AND PANDA WARMER Ohmeda Medical FMT Class II 2009-04-16
K090031 ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010 Actherm, Inc. FLL Class II 2009-04-16
K082997 TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER Terumo Medical Corp. FOZ Class II 2009-04-15
K083349 BLOOD TRANSFUSION SET Shan Dong Wei Gao Group Medical Polymer Products BRZ Class II 2009-04-10
K090189 ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE Icu Medical, Inc. FPA Class II 2009-04-10
K090087 MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM Iradimed Corporation FRN Class II 2009-04-07
K082806 SPINNING SPIROS, MODEL CH-2000 Icu Medical, Inc. FPA Class II 2009-04-06
K090327 POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE Wear Safe (Malaysia) Sdn. Bhd. LYY Class I 2009-04-03
K083482 COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET Cook Vascular, Inc. FPA Class II 2009-04-02
K090003 ZETAJET Bioject, Inc. KZE Class II 2009-04-02
K082177 KIMGUARD ONE-STEP STERILIZATION WRAP Kimberly-Clark Corp. FRG Class II 2009-03-27
K090512 POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER C.R. Bard, Inc. LJT Class II 2009-03-27
K090634 PHASEAL PROTECTOR P14, P21, P28 AND P50 Carmel Pharma Ab. LHI Class II 2009-03-23
K082689 STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE Spectra Medical Devices, Inc. NGT Class II 2009-03-20
K083873 PICC (CT RATED AND NON-RATED) Pfm Medical, Inc. LJS Class II 2009-03-19
K090537 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Tangshan Jiteng Plastic Products Co., Ltd. LYZ Class I 2009-03-19
K090562 SMITH & NEPHEW INSTRUMENT TRAYS Smith & Nephew, Inc. KCT Class II 2009-03-18
K090514 VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES STERIS Corporation FRC Class II 2009-03-16
K083295 SERIM DISINTEK GTA 2.1%, MODEL: 5164 Serim Research Corp. JOJ Class II 2009-03-16
K083763 ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN R4 Vascular, Inc. LJS Class II 2009-03-16
K081953 SUPERCATH 5 Togo Medikit Co., Ltd. FOZ Class II 2009-03-12
K083185 CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1 Cadi Scientific Pte.Ltd FLL Class II 2009-03-11
K081970 BIOCLEAN CHEMO SHIELD Nitritex (M) Sdn. Bhd. LZA Class I 2009-03-11
K090395 FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E Taidoc Technology Corporation FLL Class II 2009-03-10
K083206 LOUSEBUSTER Larada Sciences LJL Class I 2009-03-10
K090502 NOVA SAFE SCALP VEIN BLOOD COLLECTION SET U.S. Safety Syringes Co., Inc. FOZ Class II 2009-03-10
K083015 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Goldenline Plastic Product Co., Ltd. LYZ Class I 2009-03-10
K083908 BLACK NITRILE EXAMINATION GLOVES Innovative Gloves Co;, Ltd. LZA Class I 2009-03-06
K083650 EMU-GRAPH 4 EMULATOR, MODEL CI 144 Steritec Products, Inc. JOJ Class II 2009-03-05
K083755 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS Siam Sempermed Corp., Ltd. LZA Class I 2009-03-05
K083081 MODIFICATION TO SECURACATH, MODEL: SPK01 Interrad Medical, Inc. OKC Class II 2009-03-04
K083511 ENVIRO SHARP SOLUTIONS 3 Industrial Water Solutions, Inc. MMK Class II 2009-03-03
K083179 MEDILED PHOTOTHERAPY LAMP Medix I.C.S.A. LBI Class II 2009-02-27
K090294 FORA IR22 EAR THERMOMETER, MODEL TD-1262 Taidoc Technology Corporation FLL Class II 2009-02-26
K081532 PHARMAJET NEEDLE-FREE INJECTION SYSTEM Pharmajet, Inc. KZE Class II 2009-02-26
K082836 ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES Icu Medical, Inc. FMG Class II 2009-02-25
K083752 GLUSEAL 90, MODEL GLU9010 Glustitch, Inc. KMF Class I 2009-02-23
K090162 EVICEL APPLICATION DEVICE Omrix Biopharmaceuticals , Ltd. FMF Class II 2009-02-20
K083225 FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. LZG Class II 2009-02-20
K083600 VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) Quantum Co., Ltd. LYZ Class I 2009-02-19
K083259 PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE Tangshan Zhongying Plastic Products Co., Ltd. LYZ Class I 2009-02-17
K090016 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Suqian Clean Glove Co., Ltd. LYZ Class I 2009-02-13
K083457 TACTIPEN Haselmeier GmbH FMF Class II 2009-02-13
K081264 STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 Children'S Health First, Inc. FMQ Class I 2009-02-13
K083193 REVAC AUTO RETRACTABLE SAFETY SYRINGE Revolutions Medical Corporation, Inc. FMF Class II 2009-02-13
K082027 FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 Genesis Bps, LLC FPA Class II 2009-02-13
K083047 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Wanci Plastic & Rubber Co., Ltd. LYZ Class I 2009-02-12
K090089 BELMONT HYPERTHERMIA PUMP Belmont Instrument Corp. LGZ Class II 2009-02-12
K083121 NEO MAPCATH SENSOR STYLET Corpak Medsystems OMF Class II 2009-02-11
K083624 POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES Comfort Rubber Gloves Ind. Sdn. Bhd. LZA Class I 2009-02-10
K082428 N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE Best Glove, Inc. LZA Class I 2009-02-10
K082690 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Hebei Handform Plastic Products Co., Ltd. LYZ Class I 2009-02-09
K090122 NUOVOGUARD U.S. Safety Syringes Co., Inc. FOZ Class II 2009-02-05
K080779 IRRISEPT WOUND CLEANSING SYSTEM Irrimax Corporation FQH Class II 2009-02-04
K082691 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Hebei Handform Plastic Products Co., Ltd. LYZ Class I 2009-02-04
K083221 AIDERA DIASEND Aidera AB MRZ Class II 2009-02-03
K083152 EQUASHIELD SYSTEM Plastmed, Ltd. LHI Class II 2009-02-02
K080117 PATIENT ISOLATION UNIT, MODEL G019-1000 Gentex Corporation LGM Class II 2009-01-30
K083717 POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK Gx Corporation Sdn Bhd LZA Class I 2009-01-30
K090096 ALL-IN-ONE CONTAINER Baxter Healthcare Corporation KPE Class II 2009-01-30
K083337 NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES Terang Nusa Sdn Bhd LYY Class I 2009-01-27
K082138 AIRGENT, MODEL AG7000010 Perfaction, Inc. KZE Class II 2009-01-23
K083176 PASTURE, MODELS: F550, A520 Pasture Pharma Pte, Ltd. NZJ Class II 2009-01-23
K082511 MEDIGARD BLOOD COLLECTION DEVICE Medigard Limited FMI Class II 2009-01-16
K081911 NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE Siam Sempermed Corp., Ltd. LZA Class I 2009-01-15
K082936 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Litong Plastic Products Co., Ltd. LYZ Class I 2009-01-12
K082598 POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE Tangshan Zhonghong Pulin Group Co., Ltd. LZA Class I 2009-01-07
K073618 VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK STERIS Corporation FRC Class II 2009-01-07
K082435 AMSCO EVOLUTION MEDIUM STEAM STERILIZER STERIS Corporation FLE Class II 2008-12-30
K083765 MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL Medegen Medical Manufacturing Services FPA Class II 2008-12-30
K083576 MISER CONTRAST MANAGEMENT SYSTEM Merit Medical Systems, Inc. FPA Class II 2008-12-23
K082818 SUBCUTANEOUS NEEDLE INFUSION SET Marcal Medical, Inc. FPA Class II 2008-12-23
K081971 BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES Nitritex (M) Sdn. Bhd. LZC Class I 2008-12-23
K082837 STERILE FIELD SALINE PRE-FILLED SYRINGE(S) Excelsior Medical Corp. NGT Class II 2008-12-18
K082765 ASTOFLO PLUS Stihler Electronic GmbH LGZ Class II 2008-12-18
K082783 CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE Smiths Medical MD, Inc. MRZ Class II 2008-12-17

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