meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
2002-01-22

Clearances · page 63 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K013794 POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Shen Wei (Usa), Inc. LYY Class I 2002-01-22
K013262 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES Great Glove (Thailand) Co. , Ltd. LYY Class I 2002-01-22
K013795 POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR Shen Wei (Usa), Inc. LYY Class I 2002-01-22
K013228 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR Minnesota Mining and Mfg. Co. JOJ Class II 2002-01-18
K013554 POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) Maxter Glove Manufacturing Sdn Bhd LYY Class I 2002-01-17
K012879 EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE Exelint Intl. Co. FPA Class II 2002-01-17
K014062 SIMPLICITY EASY ACCESS INFUSION SET Sterling Medivations, Inc. FPA Class II 2002-01-17
K013498 CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) Maxter Glove Manufacturing Sdn Bhd LYY Class I 2002-01-17
K014061 SIMPLICITY STARPLUS SOFT INFUSION SET Sterling Medivations, Inc. FPA Class II 2002-01-17
K013950 VENTED VIAL ACCESS DEVICE Churchill Medical Systems, Inc. FPA Class II 2002-01-10
K011238 RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM Metracor Technologies, Inc. LZF Class II 2002-01-08
K013976 BOEHRINGER MRI SUCTION REGULATORY Boehringer Laboratories KDP Class II 2002-01-08
K013589 CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA Supermax Glove Manufacturing Sdn Bhd LYY Class I 2002-01-08
K013523 CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 Shire Biologics, Inc. LHI Class II 2002-01-07
K013556 MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE Tyco Healthcare FOZ Class II 2001-12-31
K012029 REMEDY MODEL 2Z12 Apollo Corp. KMG Class II 2001-12-31
K014091 STRYKER PAINPUMP Stryker Corp. FRN Class II 2001-12-31
K013942 POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) Wrp Specialty Products Sdn. Bhd. LYY Class I 2001-12-31
K013225 INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE Medafor, Inc. KMF Class I 2001-12-26
K013800 INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 2001-12-21
K013320 BLUE LATEX EXAMINATION GLOVES, POWDER FREE Arista Latindo Industrial Ltd. P.T LYY Class I 2001-12-19
K013317 TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) Tekmedic (M) Sdn Bhd LYY Class I 2001-12-17
K013293 NIPRO HYPODERMIC NEEDLE Nipro Medical Corp. FMI Class II 2001-12-14
K013801 ULTRASAFE DENTAL INJECTION SYSTEM Safety Syringes, Inc. MEG Class II 2001-12-13
K013767 SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP Sterling Medivations, Inc. FRN Class II 2001-12-12
K013807 MICROJET QUARK, MODEL U100 OR U40 Cane S.R.L. LZG Class II 2001-12-12
K012501 H.M.T. ACUPUNCTURE NEEDLE Hummingbird Medical Technology, LLC MQX Class II 2001-12-11
K012583 ACUGLIDE BRAND ACUPUNCTURE NEEDLES Helio Medical Supplies, Inc. MQX Class II 2001-12-11
K001003 Z-NET Demite Limited FMW Class I 2001-12-10
K013753 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR Canopus Medical Supply Co., Ltd. LYZ Class I 2001-12-10
K013256 BI-3M NEEDLE-FREE INJECTOR SYSTEM Felton International, Inc. KZE Class II 2001-12-07
K013333 LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM Innovative Gloves Co;, Ltd. LYY Class I 2001-12-07
K013244 COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE Med Gen, Inc. FQM Class I 2001-12-07
K993535 METAPAK MULTI-PURPOSE INSTRUMENT TRAY Riley Medical, Inc. FRG Class II 2001-12-07
K013537 ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) Koon Seng Sdn Bhd LYY Class I 2001-12-07
K013928 PAIN CARE 3200 Breg, Inc. MEB Class II 2001-12-03
K013502 SIMPLICITY CLASSIC WING QD INFUSION SET Sterling Medivations, Inc. FPA Class II 2001-12-03
K013288 NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E Sgmp Co., Ltd. LYY Class I 2001-12-03
K013287 NIPRO SAFELET CATH Nipro Medical Corp. FOZ Class II 2001-12-03
K013443 POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 Maxter Glove Manufacturing Sdn Bhd LYY Class I 2001-11-29
K013261 MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE Shanghai Motex Healthcare Co., Ltd. LZA Class I 2001-11-29
K001879 INFUSION IV SET Nirvi Intl. USA LRS Class II 2001-11-20
K013782 DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE Disetronic Medical Systems FMI Class II 2001-11-20
K013239 COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES Med Gen, Inc. FMQ Class I 2001-11-20
K012853 SMART GLOVE STERILE NITRILE EXAM GLOVE Smart Glove Corp. Sdn Bhd LZA Class I 2001-11-16
K012856 STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G Smart Glove Corp. Sdn Bhd LYY Class I 2001-11-16
K013087 SINGLE DOSE DISPENSING PIN, MODEL 2201 Alaris Medical Systems, Inc. LHI Class II 2001-11-13
K012815 SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE Kimberly-Clark Corp. LYY Class I 2001-11-13
K013362 AUTOJECT 2 Owen Mumford USA, Inc. KZH Class II 2001-11-13
K013394 LIFTLOC SAFETY INFUSION SET Specialized Health Products, Inc. FPA Class II 2001-11-08
K013073 INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 2001-11-08
K010819 3CC NMT SAFETY SYRINGE New Medical Technology , Ltd. MEG Class II 2001-11-08
K012429 SURESET INFUSION SET, MODEL 8023 Applied Diabetes Research, Incorporated FPA Class II 2001-11-06
K002937 TST CONTROL INTEGRATOR FOR STEAM STERILIZERS Albert Browne , Ltd. LRT Class II 2001-11-05
K012714 ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR Koon Seng Sdn Bhd LYY Class I 2001-10-31
K011248 CW DISPOSABLE ACUPUNCTURE NEEDLE Acusupply, Inc. MQX Class II 2001-10-29
K012868 MICROMEDICS FIBRIJET AEROSOL APPLICATOR Micromedics, Inc. FMF Class II 2001-10-29
K012736 MONOJECT SAFETY NEEDLE Tyco Healthcare FMI Class II 2001-10-25
K012121 SECUREGUARD RETRACTABLE SAFETY SYRINGE Safegard Medical Products, Inc. MEG Class II 2001-10-24
K012832 COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 Nxstage Medical, Inc. LGZ Class II 2001-10-24
K013016 TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE Tillotson Healthcare Corp. LZA Class I 2001-10-19
K012726 PROSAFE SAFETY SYRINGE Hou-Se Medical, Inc. MEG Class II 2001-10-18
K011247 HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE Acusupply, Inc. MQX Class II 2001-10-17
K012499 ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES Shanghai Antares Industries, Inc. LYZ Class I 2001-10-16
K012339 ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW Shanghai Antares Industries, Inc. LYZ Class I 2001-10-16
K013164 SURSHIELD SAFETY WINGED BLOOD COLLECTION SET Terumo Medical Corp. FPA Class II 2001-10-15
K012641 FAS ENDOLUMINAL BRUSH Fas Medical , Ltd. LJS Class II 2001-10-15
K013026 POWDERED LATEX EXAMINATION GLOVES Great Glove (Thailand) Co. , Ltd. LYY Class I 2001-10-15
K011283 MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE The Kendall Company NGT Class II 2001-10-15
K013121 MT ALERT INFUSION MONITOR Sierra Biosearch, Inc. FLN Class II 2001-10-15
K012402 OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM Omnigrace (Thailand) , Ltd. LYY Class I 2001-10-12
K013286 CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA Tillotson Healthcare Corp. LYY Class I 2001-10-12
K012464 HELIX HYDRO-JET Andreas Pein Medizintechnik GmbH FQH Class II 2001-10-10
K010477 AUTO-LOCK Auto-Lock MEG Class II 2001-10-09
K012906 ANIMEC, MODELS AM-2S-4 AND AM-2S-5 Elltec Co., Ltd. LGZ Class II 2001-10-09
K012710 DISPOSABLE POWDERED VINYL EXAMINATION GLOVES Shijiazhuang Brilliance Plastic Co., Ltd. LYZ Class I 2001-10-04
K013104 SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE Sterling Medivations, Inc. FPA Class II 2001-10-02
K012383 GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C Alaris Medical Systems, Inc. FRN Class II 2001-10-02
K012786 POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) Shamrock Manufacturing Company LZA Class I 2001-10-01
K012876 DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Wrp Specialty Products Sdn. Bhd. LYY Class I 2001-10-01
K012335 BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS Albert Browne , Ltd. JOJ Class II 2001-10-01
K012283 SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE Safegard Medical Products, Inc. FMI Class II 2001-10-01
K012709 POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN) Qingdao Bestex Rubber & Plastic Products Co., Ltd. LYY Class I 2001-10-01
K011405 EXEL INJECTION PLUG WITH CAP Exelint Intl. Co. FPA Class II 2001-09-27
K011961 POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 Shen Wei (Usa), Inc. LZA Class I 2001-09-26
K012149 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM Allegiance Healthcare Corp. LYY Class I 2001-09-24
K012857 NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O Sgmp Co., Ltd. LYY Class I 2001-09-21
K010232 PRE-POWDERED NITRILE EXAMINATION GLOVES P.T. Healthcare Glovindo LZA Class I 2001-09-21
K012860 POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G) Sgmp Co., Ltd. LYY Class I 2001-09-21
K012863 NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Sgmp Co., Ltd. LYY Class I 2001-09-21
K011087 ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE Orthovita, Inc. FMF Class II 2001-09-19
K011975 HORIZON OUTLOOK WITH DOSECOM B.Braun Medical, Inc. FRN Class II 2001-09-19
K012515 BIFURCATED VACCINATING NEEDLE Precision Medical Products, Inc. SCL Class II 2001-09-19
K012711 DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Brilliance Plastic Co., Ltd. LYZ Class I 2001-09-18
K012899 GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE Best Manufacturing Company LZA Class I 2001-09-18
K011613 POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE Shield Gloves Manufacturer (M) Sdn Bhd LZA Class I 2001-09-17
K012558 POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS Matang Mfg. Sdn. Bhd. LYY Class I 2001-09-17
K011059 INFARED EAR THERMOMETER, MODEL TH8 SERIES Radiant Innovation, Inc. FLL Class II 2001-09-17
K011979 ALLERSHARP ALLERGY SKIN TESTER Hmb Medical Concepts, Ltd. SCL Class II 2001-09-14
K012845 SIMPLICITY SOFT QD MICRO INFUSION SET Sterling Medivations, Inc. FPA Class II 2001-09-14

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