meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
30
Latest Decision
2002-08-22

Clearances · page 61 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K021293 ARTERIA BLOOD FILTER Arteria Medical Science, Inc. FPB Class II 2002-08-22
K022102 CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR Latexx Manufacturing Sdn.Bhd. LZA Class I 2002-08-22
K022575 PERFUSOR COMPACT WITH FM SYSTEM B.Braun Medical, Inc. FRN Class II 2002-08-21
K021315 SURE-LOK Vital Signs, Inc. FMI Class II 2002-08-21
K012931 GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM Allegiance Healthcare Corp. FRG Class II 2002-08-20
K022542 PHILIPS BABY THERMOMETER SET (SBC SC530) Philips Consumer Electronics FLL Class II 2002-08-20
K022347 MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES Latexx Manufacturing Sdn.Bhd. LZA Class I 2002-08-15
K022548 MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES Latexx Manufacturing Sdn.Bhd. LZA Class I 2002-08-15
K021904 MAEDA SILVER ACUPUNCTURE NEEDLE Maeda Toyokichi Shoten MQX Class II 2002-08-14
K020655 DELTEC INSULIN INFUSION PUMP AND ACCESSORIES Deltec, Inc. LZG Class II 2002-08-13
K013828 GLOVCO EBONY Glovco (M) Sdn. Bhd. LYY Class I 2002-08-13
K021999 GRIPPER PLUS NEEDLE Deltec, Inc. FPA Class II 2002-08-13
K021659 PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) P.T. Healthcare Glovindo LYY Class I 2002-08-12
K021964 ALPHA INFUSION PUMP AND CATHETERS Advanced Infusion, Inc. MEB Class II 2002-08-12
K022233 HYDROBOOT Incappe, Inc. DWL Class II 2002-08-12
K022523 RAPID-FILL TUBESET, MODEL 90005 Baxa Corp. LHI Class II 2002-08-12
K021668 NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR) Innovative Gloves Co;, Ltd. LZA Class I 2002-08-12
K022095 DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE Wilshire Technologies LZA Class I 2002-08-09
K022305 MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE Heyuan Hongli Industries, Inc. LYZ Class I 2002-08-08
K021064 QUANTIM 16 AUTOCLAVE Scican FLE Class II 2002-08-08
K021974 MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 Minimed, Inc. MRZ Class II 2002-08-06
K022248 STRYKER L3 HYDROLERT Stryker Endoscopy FLN Class II 2002-08-06
K022209 ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS Alaris Medical Systems, Inc. FPA Class II 2002-08-06
K021753 E-CARE INFARED EAR THERMOMETER, MODEL LCT-200 E-Care Technology Corporation FLL Class II 2002-08-06
K020520 EASYTEM EAR THERMOMETER, MODEL BT-020 Metatech Co., Ltd. FLL Class II 2002-08-06
K021855 TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) Top Glove Sdn. Bhd. LYY Class I 2002-08-05
K022317 DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS Sooil Development Co., Ltd. LZG Class II 2002-08-02
K022101 MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR Latexx Manufacturing Sdn.Bhd. LZA Class I 2002-08-02
K021725 DISETRONIC D-TRON INSULIN INFUSION PUMP Disetronic Medical Systems AG LZG Class II 2002-08-02
K022246 MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM Depuyacromed FMF Class II 2002-08-02
K012105 POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM Symmetry Medical, Inc. KCT Class II 2002-08-02
K022203 ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 Abbott Laboratories MEA Class II 2002-08-01
K021950 TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES Top Glove Medical (Thailand) Co., Ltd. LYY Class I 2002-08-01
K020040 LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM Pt. Maja Agung Latexindo LYY Class I 2002-08-01
K021452 STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE Maxxim Medical LZA Class I 2002-08-01
K022024 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN) Best Manufacturing Company LZA Class I 2002-08-01
K021853 DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E Shanghai Antares Industries, Inc. LYZ Class I 2002-08-01
K021041 WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES W.A. Rubbermate Co., Ltd. LYY Class I 2002-07-30
K020042 HYCARE LATEX EXAMINATION GLOVE, POWDER FREE Hycare Intl. Co., Ltd. LYY Class I 2002-07-30
K021504 TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 Tuttnauer U.S.A Co, Ltd. FLE Class II 2002-07-25
K012974 PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 Prizm Medical, Inc. FLL Class II 2002-07-23
K022148 INJEX 30 NEEDLE FREE INJECTION SYSTEM Equidyne Systems, Inc. KZE Class II 2002-07-23
K021475 BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET Bd FMI Class II 2002-07-19
K020409 STEAMPLUS STERILIZATION TEST Spsmedical Supply Corp. JOJ Class II 2002-07-18
K021809 V-2100G ADVANCED INFANT INCUBATOR Atom Medical Corp FMZ Class II 2002-07-18
K013926 QIZHOU ACUPUNCTURE NEEDLE Wujiang City Shenli Medical and Health Material CO MQX Class II 2002-07-18
K021851 DIGITAL CLINICAL THERMOMETER, MODEL KD-193 K-Jump Health Co., Ltd. FLL Class II 2002-07-17
K020926 EXTENSION SET, MODELS 1911-512 Epimed International, Inc. FPA Class II 2002-07-12
K020921 NO-POKES NEEDLE SAFETY DEVICE Bemis Mfg. Co. FMI Class II 2002-07-11
K022087 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR Shanghai PT Plastics Enterprise Company, Ltd. LYZ Class I 2002-07-11
K020433 FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER Idt Technology Limited FLL Class II 2002-07-11
K021601 MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER Duteck Industrial Co., Ltd. FLL Class II 2002-07-10
K021488 SURECAN SAFETY HUBER NEEDLE INFUSION SETS B.Braun Medical, Inc. FPA Class II 2002-07-08
K020818 POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS Allegiance Healthcare Corp. LYY Class I 2002-07-05
K021007 ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL Tillotson Healthcare Corp. LYY Class I 2002-07-05
K021730 GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE) Glovco (M) Sdn. Bhd. LZA Class I 2002-07-05
K021084 LIGHT SABER SPINAL NEEDLE Minrad, Inc. FMF Class II 2002-07-03
K002741 BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK Albert Browne , Ltd. JOJ Class II 2002-07-03
K021961 POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE Copioumed Intl., Inc. LYZ Class I 2002-07-02
K021521 STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES Smart Glove Corp. Sdn Bhd LYY Class I 2002-07-02
K021071 PCCS GRAFT DELIVERY SYSTEM Biomet, Inc. FMF Class II 2002-07-01
K013182 TRIPLE LUMEN CENTRAL VENOUS CATHETER Cook, Inc. FOZ Class II 2002-07-01
K021480 EXTENSION SET LIGHT-SAFE, MODEL BC565 Codan US Corp. FPA Class II 2002-06-27
K014114 GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX Nipro Diabetes Systems, Inc. FMF Class II 2002-06-26
K021223 BELIMED STEAM STERILIZER, MODEL TOP 5000 Sauter AG FLE Class II 2002-06-26
K020205 CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT Getinge/Castle, Inc. FRC Class II 2002-06-24
K013309 GLUCOPRO EVO INFUSION PUMP Nipro Diabetes Systems, Inc. LZG Class II 2002-06-24
K020996 MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL Medefil, Inc. NGT Class II 2002-06-24
K020666 DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML Baxter Healthcare Corp FMF Class II 2002-06-24
K020999 MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL Medefil, Inc. NGT Class II 2002-06-20
K020966 RPI REPLACEMENT HEATING ELEMENTS Replacement Parts Industries, Inc. FMT Class II 2002-06-13
K021561 DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O Wrp Specialty Products Sdn. Bhd. LYY Class I 2002-06-11
K021667 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE Safehealth Medical Supply Corp. LYZ Class I 2002-06-11
K020880 MARKNEW PRODUCTS ACUPUNCTURE NEEDLES Marknew Products MQX Class II 2002-06-10
K021743 (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW Copioumed Intl., Inc. LZA Class I 2002-06-10
K021388 CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM Seal Polymer Industries Bhd. LYY Class I 2002-06-10
K021536 DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR Wrp Specialty Products Sdn. Bhd. LYY Class I 2002-06-10
K021412 LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED Arista Latindo Industrial Ltd. P.T LYY Class I 2002-06-07
K014088 DUPLOREACH Baxter Healthcare Corp FMF Class II 2002-06-07
K013980 SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES Safe Shield Co., Ltd. LYY Class I 2002-06-06
K021704 VAXCEL PICC WITH PASV VALVE TECHNOLOGY Catheter Innovations, Inc. LJS Class II 2002-06-06
K021220 NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS Siam Sempermed Corp., Ltd. LZA Class I 2002-06-06
K020943 STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE Shanghai Antares Industries, Inc. LYZ Class I 2002-06-06
K021506 POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES Shijiazhuang Great Vision Plastic Products Co., LT LZA Class I 2002-06-06
K021353 POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE Glormed Intl., Inc. LYZ Class I 2002-06-06
K021700 ANIMUS EZSERTER INFUSION SET INSERTER Animas Corp. KZH Class II 2002-06-04
K021531 RPI REPLACEMENT PHOTOTHERAPY LIGHTS Replacement Parts Industries, Inc. LBI Class II 2002-05-31
K021000 SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES Shanghai Glovmax Enterprise Co.,Ltd LZA Class I 2002-05-31
K021614 DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020 Actherm, Inc. FLL Class II 2002-05-30
K021612 DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038 Actherm, Inc. FLL Class II 2002-05-30
K021439 MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO Animas Corp. LZG Class II 2002-05-29
K021465 MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE Industrial Clothings, Ltd. LYY Class I 2002-05-22
K021013 SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE) Smart Glove Corp. Sdn Bhd LZA Class I 2002-05-22
K021530 SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN Sterling Medivations, Inc. FPA Class II 2002-05-21
K021487 SIMPLICITY EASY ACCESS P INFUSION SET Sterling Medivations, Inc. FPA Class II 2002-05-17
K020747 AMSCO CENTURY MEDIUM STERILIZER 26 X 26 STERIS Corporation FLE Class II 2002-05-17
K021095 HOLY DRAGON BRAND ACUPUNCTURE NEEDLES Wujiang City Hua Xin Medical Appliance Co., Ltd. MQX Class II 2002-05-17
K021274 PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 Baxter Healthcare Corp MEB Class II 2002-05-17
K021396 DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE Wrp Specialty Products Sdn. Bhd. LZA Class I 2002-05-16
K021001 SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES Shanghai Glovmax Enterprise Co.,Ltd LZA Class I 2002-05-16

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