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General Hospital

15,616 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 (K021197)Hosuk Co., Ltd.2002-04-26
MICROJET CRONO (K013234)Cane S.R.L.2002-04-26
SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE (K021005)Sterling Medivations, Inc.2002-04-25
ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K020838)Ar Alliance Healthcare Sdn. Bhd.2002-04-23
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE (K020589)3M Company2002-04-22
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) (K020868)Seal Polymer Industries Bhd.2002-04-22
THERMOMETER MODELS ST8631 (K021048)Z7 International2002-04-22
TRULINE REINFORCED VALVED INFUSION CATHETER (K021139)Micro Therapeutics, Inc.2002-04-17
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS (K020947)Smith & Nephew, Inc.2002-04-17
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 (K013621)Becton Dickinson Infusion Therapy Systems, Inc.2002-04-16
RPI SKIN OR AIR TEMPERATURE PROBE (K020219)Replacement Parts Industries, Inc.2002-04-12
GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) (K020363)Great Glove Sdn Bhd2002-04-10
SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN (K020990)Sterling Medivations, Inc.2002-04-10
SIMPLICITY EASY SOFT INFUSION SET (K020912)Sterling Medivations, Inc.2002-04-10
MODEL GT010706 ELECTRONIC THERMOMETER (K021052)Global Treasure Industries , Ltd.2002-04-09
MODEL GT980201 ELECTRONIC THERMOMETER (K021028)Global Treasure , Ltd.2002-04-08
SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 (K020252)Harvest Technologies, Corp.2002-04-05
PAIN CARE 4200 (K020988)Breg, Inc.2002-04-04
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 (K020592)Alba-Waldensian, Inc.2002-04-03
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP (K020147)Medtronic Perfusion Systems2002-04-03
SIMPLICITY SIMPLEX SOFT INFUSION SET (K020629)Sterling Medivations, Inc.2002-04-01
RE-USABLE STERILIZATION POUCH / BAG (K013715)Quality Products of Montana2002-04-01
LIFEGUARD SAFETY INFUSION SET (K013871)Horizon Medical Products, Inc.2002-03-29
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F (K013779)Mesure Technology2002-03-29
CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP (K013714)Codan US Corp.2002-03-28
UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR (K013949)Churchill Medical Systems, Inc.2002-03-27
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT (K020881)Science Incorporated2002-03-27
I-FLOW ELASTOMERIC PUMP (K020862)I-Flow Corp.2002-03-26
3M ATTEST 290 AUTO-READER (K004009)3M Company2002-03-25
MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER (K020590)Getinge/Castle, Inc.2002-03-20
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO (K020660)I-Flow Corp.2002-03-20
LATEX EXAMINATION GLOVES (POWDER FREE) (K014279)Brightway Gloves Pvt. , Ltd.2002-03-20
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 (K020523)Bd2002-03-20
LATEX EXAMINATION GLOVE (POWDERED) (K014280)Brightway Gloves Pvt. , Ltd.2002-03-20
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE (K020500)Univec, Inc.2002-03-19
WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA (K020544)Churchill Medical Systems, Inc.2002-03-12
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1 (K020725)Microlife Corp.2002-03-12
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML (K020485)Baxter Healthcare Corp2002-03-12
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS (K013267)Siam Sempermed Corp., Ltd.2002-03-08
ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES (K020359)Ar Alliance Healthcare Sdn. Bhd.2002-03-06
CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA (K013774)Supermax Sdn Bhd2002-03-05
ANGELTOUCH VENTED IV ADMINISTRATION SET (K012189)Angiplast Private , Ltd.2002-03-05
SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K013821)Top Quality Mfg., Inc.2002-03-05
INTEGRAPH FLASH, MODEL CI 110 (K012732)Steritec Products, Inc.2002-03-04
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE (K014087)Latexx Manufacturing Sdn.Bhd.2002-03-04
INFRARED EAR THERMOMETER, MODEL DX-707 (K013876)Jawon Medical Co., Ltd.2002-03-04
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT (K014110)Siam Sempermed Corp., Ltd.2002-02-28
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E (K014112)Siam Sempermed Corp., Ltd.2002-02-28
INFRARED EAR THERMOMETER, MODELS TH88 SERIES (K020504)Radiant Innovation, Inc.2002-02-28
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE (K020493)Syntex Healthcare Products Co., Ltd.2002-02-26
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM (K013953)Supermax Glove Manufacturing Sdn Bhd2002-02-26
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE (K013996)Pt. Maja Agung Latexindo2002-02-26
VINYL EXAMINATION GLOVES STERILE POWEDERED (K020044)Primus Gloves Private , Ltd.2002-02-26
HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 (K014174)Barnstead/Thermolyne Corp.2002-02-22
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE (K014284)Formosa Glove Industrial Co., Ltd.2002-02-15
PARAGON INFUSION SYSTEM (K020251)I-Flow Corp.2002-02-15
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE (K014285)Formosa Glove Industrial Co., Ltd.2002-02-14
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE (K020317)Sgmp Co., Ltd.2002-02-14
HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE (K014073)Portex, Inc.2002-02-13
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES (K013998)Sheen More Ent. Co., Ltd.2002-02-13
STERRAD CYCLESURE BIOLOGICAL INDICATOR (K994055)Advanced Sterilization Products2002-02-13
OVUS CAPLESS SAFETY NEEDLE (K013006)Ovus Systems2002-02-06
ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM (K012549)Healthway Products, Inc.2002-02-04
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES (K014077)Shijiazhuang Great Vision Plastic Products Co., LT2002-02-04
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K013254)Top Quality Mfg., Inc.2002-02-04
FINN CHAMBER (R) (K013820)Epitest Ltd. OY2002-01-30
RAVEN BACTERIAL SPORE STRIPS (K020026)Raven Biological Laboratories, Inc.2002-01-30
JOBST READY-TO-WEAR GAUNTLET (K013852)Bsn-Jobst, Inc.2002-01-28
NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING (K014055)Seal Polymer Industries Bhd.2002-01-28
SALINE IV FLUSH SYRINGE (K002142)Emt-Rx2002-01-28
BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE (K011967)Bd2002-01-23
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER (K013303)Latexx Manufacturing Sdn.Bhd.2002-01-23
EXEL COMFORTPOINT INSULIN PEN NEEDLE (K011757)Exelint Intl. Co.2002-01-23
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K013794)Shen Wei (Usa), Inc.2002-01-22
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) (K014134)Supergrade Healthcare Products Sdn. Bhd.2002-01-22
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR (K013795)Shen Wei (Usa), Inc.2002-01-22
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K013262)Great Glove (Thailand) Co. , Ltd.2002-01-22
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS (K013793)Shen Wei (Usa), Inc.2002-01-22
UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES (K013163)N.S. Uni-Gloves Sdn. Bhd.2002-01-22
3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR (K013228)Minnesota Mining and Mfg. Co.2002-01-18
EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE (K012879)Exelint Intl. Co.2002-01-17
SIMPLICITY STARPLUS SOFT INFUSION SET (K014061)Sterling Medivations, Inc.2002-01-17
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K013498)Maxter Glove Manufacturing Sdn Bhd2002-01-17
SIMPLICITY EASY ACCESS INFUSION SET (K014062)Sterling Medivations, Inc.2002-01-17
POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K013554)Maxter Glove Manufacturing Sdn Bhd2002-01-17
VENTED VIAL ACCESS DEVICE (K013950)Churchill Medical Systems, Inc.2002-01-10
RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM (K011238)Metracor Technologies, Inc.2002-01-08
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA (K013589)Supermax Glove Manufacturing Sdn Bhd2002-01-08
BOEHRINGER MRI SUCTION REGULATORY (K013976)Boehringer Laboratories2002-01-08
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 (K013523)Shire Biologics, Inc.2002-01-07
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE (K013556)Tyco Healthcare2001-12-31
STRYKER PAINPUMP (K014091)Stryker Corp.2001-12-31
REMEDY MODEL 2Z12 (K012029)Apollo Corp.2001-12-31
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) (K013942)Wrp Specialty Products Sdn. Bhd.2001-12-31
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE (K013225)Medafor, Inc.2001-12-26
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE (K013800)Becton Dickinson Infusion Therapy Systems, Inc.2001-12-21
BLUE LATEX EXAMINATION GLOVES, POWDER FREE (K013320)Arista Latindo Industrial Ltd. P.T2001-12-19
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K013317)Tekmedic (M) Sdn Bhd2001-12-17
NIPRO HYPODERMIC NEEDLE (K013293)Nipro Medical Corp.2001-12-14
ULTRASAFE DENTAL INJECTION SYSTEM (K013801)Safety Syringes, Inc.2001-12-13
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