meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
26
Latest Decision
2001-02-27

Clearances · page 66 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K010502 MODEL THERMO TEK QUICKCARE Saat , Ltd. FLL Class II 2001-02-27
K010021 MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S Medical Components, Inc. FOZ Class II 2001-02-23
K000581 MAEDA NEW NEEDLE DISPOSABLE Maeda Toyokichi Shoten MQX Class II 2001-02-23
K003470 EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 Tuttnauer Co. , Ltd. FLE Class II 2001-02-20
K010297 SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) Maxxim Medical LZA Class I 2001-02-16
K010211 STERILE NITRILE POWDER-FREE EXAMINATION GLOVES Allegiance Healthcare Corp. LZC Class I 2001-02-15
K003977 DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET Disetronic Medical Systems AG FPA Class II 2001-02-15
K003915 ACCUFUSER; ACCUFUSER PLUS Help Technologies MEB Class II 2001-02-15
K003922 NITRILE EXAMINATION GLOVES (POWERED) Guthrie Medicare Products (Melaka) Sdn Bhd LZA Class I 2001-02-15
K001329 INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET Lifemed of California FPA Class II 2001-02-14
K003571 SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE Terumo Medical Corp. FMF Class II 2001-02-12
K010189 VORTEX ACCESS SYSTEM Horizon Medical Products, Inc. LJT Class II 2001-02-12
K010231 JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE Jk Gloves Sdn. Bhd. LYY Class I 2001-02-09
K993856 TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP Tuttnauer U.S.A Co, Ltd. FLE Class II 2001-02-09
K010095 NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR Sgmp Co., Ltd. LYY Class I 2001-02-09
K003985 POWDERFREE NITRILE PATIENT EXMINATION GLOVE Guthrie Medicare Products (Melaka) Sdn Bhd LZA Class I 2001-02-09
K003627 EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET Exelint International, Co. FMI Class II 2001-02-08
K002712 THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F Saat , Ltd. FLL Class II 2001-02-08
K003533 CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L Steritec Products, Inc. JOJ Class II 2001-02-07
K002910 HOLY DRAGON ACUPUNCTURE NEEDLES Anc Import & Export Co. , Ltd. MQX Class II 2001-02-07
K004048 SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Tillotson Healthcare Corp. LYY Class I 2001-02-06
K010238 ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ Actherm, Inc. FLL Class II 2001-02-06
K003760 TAI-CHI ACUPUNCTURE NEEDLES Lhasa Medical, Inc. MQX Class II 2001-02-06
K010247 SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES Shanghai China Star Corp LZA Class I 2001-02-06
K003854 INTRAVASCULAR ADMINISTRATION SET Infusion Devices, Inc. FPA Class II 2001-02-05
K001965 SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS North American Medical Products, Inc. FMI Class II 2001-02-02
K003737 POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) Perusahaan Getah Asas Sdn. Bhd. LYY Class I 2001-02-01
K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 2001-02-01
K002338 LIQUIDERM LIQUID ADHESIVE BANDAGE Closure Medical Corp. KMF Class I 2001-01-29
K010078 GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) Guthrie Medicare Products (Melaka) Sdn Bhd LYY Class I 2001-01-29
K003934 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) Seltom Pacific Sdn. Bhd. LYY Class I 2001-01-26
K010054 GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) Guthrie Medicare Products (Melaka) Sdn Bhd LYY Class I 2001-01-26
K003682 MEDCOMP Z-CATH Medical Components, Inc. LJS Class II 2001-01-26
K003653 STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) Wrp Asia Pacific Sdn. Bhd. LYY Class I 2001-01-26
K003055 MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Medline Industries, Inc. LYY Class I 2001-01-26
K010072 POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE Wrp Asia Pacific Sdn. Bhd. LZA Class I 2001-01-26
K002719 FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A Tillotson Healthcare Corp. LYY Class I 2001-01-26
K003748 TIANXIE Suzhou Tianyi Acupuncture Instruments Co., Ltd. MQX Class II 2001-01-26
K010034 DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- Cook, Inc. FOZ Class II 2001-01-24
K003904 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES Purna Bina Sdn Bhd LYY Class I 2001-01-24
K991618 BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR Propper Mfg. Co., Inc. FRC Class II 2001-01-24
K010038 NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE Cambridge Marketing, Inc. FMI Class II 2001-01-24
K003511 KENDALL-LTP TURNER SAVE-A-LINE The Ludlow Company LP FRP Class I 2001-01-24
K002968 MEDLINE STERILIZATION WRAP Medline Industries, Inc. FRG Class II 2001-01-23
K003872 GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) Guthrie Medicare Products (Melaka) Sdn Bhd LYY Class I 2001-01-23
K003348 E.N.S.I. RETRACTABLE SAFETY SYRINGE Ensi-Med International Pty. , Ltd. MEG Class II 2001-01-12
K003406 GUARDED NEEDLE 2000 International Medical Device Partners, Inc. FMI Class II 2001-01-12
K003223 GEON DIGITAL CLINICAL THERMOMETER Geon Corp. FLL Class II 2001-01-12
K003476 MPS ACACIA PAIN KIT Mps Acacia MEB Class II 2001-01-12
K002381 PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES Pentaferte, S.R.L. FMF Class II 2001-01-11
K003513 TAXOL ADMINISTRATION SET Icu Medical, Inc. FPA Class II 2001-01-11
K003313 FILAC FAS TEMP ELECTRONIC THERMOMETER The Kendall Company FLL Class II 2001-01-11
K003675 SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES Shanghai China Star Corp LZA Class I 2001-01-09
K002717 STERILE PISTON SYRINGE Abbott Laboratories FMF Class II 2001-01-08
K003827 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION Bio-Plexus, Inc. FMI Class II 2001-01-08
K003563 POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE Ning BO Yujiang Rubber & Plastic Co. LZA Class I 2001-01-02
K003441 CASTLE MODEL 233HC STEAM STERILIZER Getinge/Castle, Inc. FLE Class II 2001-01-02
K002127 INJECTRITE-C15 AND INJECTRITE-C30 Sterling Medivations, Inc. FMF Class II 2000-12-29
K002182 AVITA TSO/TS1 INFRARED EAR THERMOMETER Avita Corporation FLL Class II 2000-12-29
K992424 SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20 Plastimed Laboratoire Pharmaceutique LJS Class II 2000-12-29
K002449 BIOTEQ I.V. (INTRAVENOUS) SET Bioteque Corp. FPA Class II 2000-12-22
K000714 VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET Med-Pro Technologies, Inc. FMI Class II 2000-12-21
K003547 NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) Terang Nusa Sdn Bhd LYY Class I 2000-12-21
K003545 NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE Terang Nusa Sdn Bhd LYY Class I 2000-12-21
K003642 PLACEMENT-PLUS Catheter Innovations, Inc. LJS Class II 2000-12-20
K003730 CHEMO-AIDE DISPENSING PIN Baxter Healthcare Corp LHI Class II 2000-12-20
K002550 RDH BANDAGE Marine Polymer Technologies, Inc. KMF Class I 2000-12-20
K003611 PAIN CARE MULTI-PORT CATHETER, MODEL 2000L Breg, Inc. FRN Class II 2000-12-13
K003283 SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103) Sterling Medivations, Inc. FPA Class II 2000-12-13
K003067 CALEO Drager Medizintechnik GmbH FMZ Class II 2000-12-13
K001233 ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S R-Group Intl. FPA Class II 2000-12-13
K003195 GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC Greer Laboratories, Inc. SCL Class II 2000-12-13
K003616 COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP Baxter Healthcare Corp FRN Class II 2000-12-12
K002411 SHENLING ACUPUNCTURE NEEDLES Shenling Medical Device Co., Ltd. MQX Class II 2000-12-12
K002569 GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES Malgam Ent., Inc. FMF Class II 2000-12-12
K002403 NOVOFINE 31 DISPOSABLE NEEDLE Novo Norodisk Pharmaceuticals, Inc. FMI Class II 2000-12-08
K003002 STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 Steritec Products, Inc. JOJ Class II 2000-12-08
K003582 FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 Fluidsense Corp. FRN Class II 2000-12-05
K002391 NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS) Siam Sempermed Corp., Ltd. LZA Class I 2000-12-04
K003029 INFUSOMAT P B.Braun Medical, Inc. FRN Class II 2000-12-04
K003245 HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML Baxter Healthcare Corp FOZ Class II 2000-12-04
K003110 MEDCOMP BIO-CATH CATHETER LINE Medcomp LJS Class II 2000-12-01
K002818 NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE Siam Sempermed Corp., Ltd. LZA Class I 2000-11-29
K002819 NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE Siam Sempermed Corp., Ltd. LZA Class I 2000-11-29
K003213 ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS Concept Rubber Products Sdn Bhd LYY Class I 2000-11-29
K002861 EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 Steritec Products, Inc. JOJ Class II 2000-11-29
K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 2000-11-29
K002064 COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL Wrp Asia Pacific Sdn. Bhd. LZA Class I 2000-11-28
K001613 COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Wrp Asia Pacific Sdn. Bhd. LZA Class I 2000-11-22
K003353 MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA Medline Industries, Inc. LZA Class I 2000-11-22
K003197 VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW Kaohsiung Brothers Products Corp. LYZ Class I 2000-11-22
K003307 DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W Wrp Specialty Products Sdn. Bhd. LYY Class I 2000-11-22
K003321 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR Shanghai Antares Industries, Inc. LYZ Class I 2000-11-22
K003309 DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE Wrp Specialty Products Sdn. Bhd. LYY Class I 2000-11-22
K002786 BIOSENSORS CENTRAL VENOUS CATHETER KITS Sunscope Intl., Inc. FOZ Class II 2000-11-17
K003335 RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER Hill-Rom Air-Shields FMT Class II 2000-11-17
K003132 DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA Wrp Specialty Products Sdn. Bhd. LYY Class I 2000-11-17
K002692 DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A Hmi Industries, Inc. FRF Class II 2000-11-17
K003308 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 Microlife Corp. FLL Class II 2000-11-14
K002720 FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO Tillotson Healthcare Corp. LYY Class I 2000-11-09

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