meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
26
Latest Decision
2002-05-15

Clearances · page 62 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K020538 BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES Boehringer Laboratories DWL Class II 2002-05-15
K020664 STERISHARP 3-GALLON RSDC, MODEL RSDC3G Sterilogic Waste Systems, Inc. MMK Class II 2002-05-14
K021350 ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 Abbott Laboratories FRN Class II 2002-05-14
K021058 SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM Syntex Healthcare Products Co., Ltd. LYY Class I 2002-05-14
K013840 MICROJET CRONO PAR AND CRONO APO-GO Cane S.R.L. FRN Class II 2002-05-14
K021059 SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM Syntex Healthcare Products Co., Ltd. LYY Class I 2002-05-14
K021308 GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES Glovco (M) Sdn. Bhd. LZA Class I 2002-05-14
K021296 SIMPLICITY QD EASY P INFUSION SET Sterling Medivations, Inc. FPA Class II 2002-05-14
K021395 MODIFICATION TO 30 EXTENSION SET Churchill Medical Systems, Inc. FPA Class II 2002-05-13
K020543 OHMEDA MEDICAL GIRAFFE OMNIBED Ohmeda Medical FMZ Class II 2002-05-09
K020547 OHMEDA MEDICAL GIRAFFE INCUBATOR Ohmeda Medical FMZ Class II 2002-05-09
K013855 MICROJET CRONO H Cane S.R.I. FRN Class II 2002-05-09
K020865 ONLINE POWDER FREE, LATEX EXAMINATION GLOVES Apl Products Sdn. Bhd. LYY Class I 2002-05-08
K021102 DM SLEEVE Emily Iker M.D., A.P.C. DWL Class II 2002-05-08
K013822 MICROJET CRONO PCA Cane S.R.L. MEA Class II 2002-05-08
K012195 STEAM STERILIZATION INTERGRATOR Dana Products, Inc. JOJ Class II 2002-05-07
K020612 SULTAN SPOROX TEST VIAL, MODEL 75195 Sultan Chemists, Inc. JOJ Class II 2002-05-07
K021216 SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS Sterling Medivations, Inc. FPA Class II 2002-05-03
K020471 HIVOX EAR THERMOMETER, TS SERIES Hivox Biotek, Inc. FLL Class II 2002-05-02
K020623 DUOPRO SAFETY SYRINGE (DUOPROSS) M.K. Meditech Co. , Ltd. MEG Class II 2002-05-02
K020751 SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE Syntex Healthcare Products Co., Ltd. LZA Class I 2002-05-02
K020053 SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES Safe Shield Co., Ltd. LYY Class I 2002-05-01
K020530 EVANS SUB-Q, MODEL MC4206 Evans Medical, Inc. FPA Class II 2002-04-29
K021197 SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 Hosuk Co., Ltd. FMF Class II 2002-04-26
K013776 MICROJET MODEL # CD4 AND CD4/20 Cane S.R.I. FRN Class II 2002-04-26
K013234 MICROJET CRONO Cane S.R.L. FRN Class II 2002-04-26
K021005 SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE Sterling Medivations, Inc. FPA Class II 2002-04-25
K020838 ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) Ar Alliance Healthcare Sdn. Bhd. LYY Class I 2002-04-23
K021048 THERMOMETER MODELS ST8631 Z7 International FLL Class II 2002-04-22
K020868 CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) Seal Polymer Industries Bhd. LZA Class I 2002-04-22
K020589 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE 3M Company JOJ Class II 2002-04-22
K020947 MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS Smith & Nephew, Inc. FRN Class II 2002-04-17
K021139 TRULINE REINFORCED VALVED INFUSION CATHETER Micro Therapeutics, Inc. FOZ Class II 2002-04-17
K013621 BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 Becton Dickinson Infusion Therapy Systems, Inc. FPA Class II 2002-04-16
K020219 RPI SKIN OR AIR TEMPERATURE PROBE Replacement Parts Industries, Inc. FMT Class II 2002-04-12
K020990 SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN Sterling Medivations, Inc. FPA Class II 2002-04-10
K020363 GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) Great Glove Sdn Bhd LYY Class I 2002-04-10
K020912 SIMPLICITY EASY SOFT INFUSION SET Sterling Medivations, Inc. FPA Class II 2002-04-10
K021052 MODEL GT010706 ELECTRONIC THERMOMETER Global Treasure Industries , Ltd. FLL Class II 2002-04-09
K021028 MODEL GT980201 ELECTRONIC THERMOMETER Global Treasure , Ltd. FLL Class II 2002-04-08
K020252 SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 Harvest Technologies, Corp. FMF Class II 2002-04-05
K020988 PAIN CARE 4200 Breg, Inc. MEB Class II 2002-04-04
K020147 MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP Medtronic Perfusion Systems FMF Class II 2002-04-03
K020592 ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 Alba-Waldensian, Inc. DWL Class II 2002-04-03
K013715 RE-USABLE STERILIZATION POUCH / BAG Quality Products of Montana FRG Class II 2002-04-01
K020629 SIMPLICITY SIMPLEX SOFT INFUSION SET Sterling Medivations, Inc. FPA Class II 2002-04-01
K013871 LIFEGUARD SAFETY INFUSION SET Horizon Medical Products, Inc. FPA Class II 2002-03-29
K013779 THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F Mesure Technology FLL Class II 2002-03-29
K013714 CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP Codan US Corp. FPA Class II 2002-03-28
K013949 UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR Churchill Medical Systems, Inc. FPA Class II 2002-03-27
K020881 MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT Science Incorporated FRN Class II 2002-03-27
K020862 I-FLOW ELASTOMERIC PUMP I-Flow Corp. MEB Class II 2002-03-26
K004009 3M ATTEST 290 AUTO-READER 3M Company FRC Class II 2002-03-25
K014280 LATEX EXAMINATION GLOVE (POWDERED) Brightway Gloves Pvt. , Ltd. LYY Class I 2002-03-20
K020660 HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO I-Flow Corp. MEB Class II 2002-03-20
K020590 MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER Getinge/Castle, Inc. FLE Class II 2002-03-20
K020523 BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 Bd SCL Class II 2002-03-20
K014279 LATEX EXAMINATION GLOVES (POWDER FREE) Brightway Gloves Pvt. , Ltd. LYY Class I 2002-03-20
K020500 UNIVEC BIFURCATED SLIDING SHEATH SYRINGE Univec, Inc. SCL Class II 2002-03-19
K020544 WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA Churchill Medical Systems, Inc. FPA Class II 2002-03-12
K020725 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1 Microlife Corp. FLL Class II 2002-03-12
K020485 ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML Baxter Healthcare Corp KPE Class II 2002-03-12
K013267 POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS Siam Sempermed Corp., Ltd. LYY Class I 2002-03-08
K020359 ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES Ar Alliance Healthcare Sdn. Bhd. LYY Class I 2002-03-06
K012189 ANGELTOUCH VENTED IV ADMINISTRATION SET Angiplast Private , Ltd. LHI Class II 2002-03-05
K013774 CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA Supermax Sdn Bhd LZA Class I 2002-03-05
K013821 SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) Top Quality Mfg., Inc. LYY Class I 2002-03-05
K014087 LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE Latexx Manufacturing Sdn.Bhd. LYY Class I 2002-03-04
K012732 INTEGRAPH FLASH, MODEL CI 110 Steritec Products, Inc. JOJ Class II 2002-03-04
K013876 INFRARED EAR THERMOMETER, MODEL DX-707 Jawon Medical Co., Ltd. FLL Class II 2002-03-04
K020504 INFRARED EAR THERMOMETER, MODELS TH88 SERIES Radiant Innovation, Inc. FLL Class II 2002-02-28
K014110 SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT Siam Sempermed Corp., Ltd. LYY Class I 2002-02-28
K014112 SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E Siam Sempermed Corp., Ltd. LYY Class I 2002-02-28
K020044 VINYL EXAMINATION GLOVES STERILE POWEDERED Primus Gloves Private , Ltd. LYZ Class I 2002-02-26
K013953 AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM Supermax Glove Manufacturing Sdn Bhd LYY Class I 2002-02-26
K020493 SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE Syntex Healthcare Products Co., Ltd. LZA Class I 2002-02-26
K013996 LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE Pt. Maja Agung Latexindo LYY Class I 2002-02-26
K014174 HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 Barnstead/Thermolyne Corp. FLE Class II 2002-02-22
K014284 NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE Formosa Glove Industrial Co., Ltd. LZA Class I 2002-02-15
K020251 PARAGON INFUSION SYSTEM I-Flow Corp. FRN Class II 2002-02-15
K014285 NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE Formosa Glove Industrial Co., Ltd. LZA Class I 2002-02-14
K020317 NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE Sgmp Co., Ltd. LZA Class I 2002-02-14
K994055 STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products FRC Class II 2002-02-13
K013998 POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES Sheen More Ent. Co., Ltd. LZA Class I 2002-02-13
K014073 HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE Portex, Inc. FMF Class II 2002-02-13
K013006 OVUS CAPLESS SAFETY NEEDLE Ovus Systems MEG Class II 2002-02-06
K012549 ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM Healthway Products, Inc. FRF Class II 2002-02-04
K014077 POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES Shijiazhuang Great Vision Plastic Products Co., LT LZA Class I 2002-02-04
K013254 POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) Top Quality Mfg., Inc. LZA Class I 2002-02-04
K020026 RAVEN BACTERIAL SPORE STRIPS Raven Biological Laboratories, Inc. FRC Class II 2002-01-30
K013820 FINN CHAMBER (R) Epitest Ltd. OY KXF Class I 2002-01-30
K014055 NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING Seal Polymer Industries Bhd. LYY Class I 2002-01-28
K002142 SALINE IV FLUSH SYRINGE Emt-Rx FOZ Class II 2002-01-28
K013852 JOBST READY-TO-WEAR GAUNTLET Bsn-Jobst, Inc. DWL Class II 2002-01-28
K011757 EXEL COMFORTPOINT INSULIN PEN NEEDLE Exelint Intl. Co. FMI Class II 2002-01-23
K013303 CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER Latexx Manufacturing Sdn.Bhd. LZA Class I 2002-01-23
K011967 BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE Bd FOZ Class II 2002-01-23
K013163 UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES N.S. Uni-Gloves Sdn. Bhd. LYY Class I 2002-01-22
K013793 POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS Shen Wei (Usa), Inc. LYY Class I 2002-01-22
K014134 POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) Supergrade Healthcare Products Sdn. Bhd. FMC Class I 2002-01-22

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