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General Hospital

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

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RecordFirmDate
Xcela Power Injectable PICC (K150527)Navilyst Medical, Inc.2015-03-31
Powder-free Clear Vinyl Patient Examination Gloves (K142892)Shenyi (Shandong) Plastic Products Co., Ltd.2015-03-25
BT-400 (K142332)Bio-Med USA2015-03-20
NMI PICC III and NMI PICC IV (K150448)Navilyst Medical, Inc.2015-03-19
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES (K141042)Mercator Medical (Thailand), Ltd.2015-03-19
Triton Canister System (K142801)Gauss Surgical, Inc.,2015-03-12
STERILIZATION POUCH/ROLL MADE WITH TYVEK (K133838)Sigma Medical Supplies Corp.2015-03-11
KIMGUARD ONE-STEP Sterilization Wrap (K142782)Kimberly-Clark Health Care2015-03-09
Patient Examination Gloves (K143419)Hartalega NGC Sdn. Bhd.2015-03-06
Hospira Blood Set (K143087)Hospira, Inc.2015-03-04
EMMA (K150174)Inrange Systems, Inc.2015-02-26
Hospira Primary Sets (K143015)Hospira, Inc.2015-02-25
Endoscope Sterilization Tray (K142937)Intuitive Surgical, Inc.2015-02-24
3S Safety Syringe with/without Needle (K142435)Sincere Medical Device Co., Ltd.2015-02-20
3S Safety Insulin Syringe (K142436)Sincere Medical Device Co., Ltd.2015-02-19
BUSSE EXTENSION SET (K141285)Busse Hospital Disposables2015-02-19
ivWatch Model 400 (K142374)Ivwatch, LLC2015-02-13
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (K143131)Kossan International Sdn Bhd2015-02-12
Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla (K143055)Yty Industry (Manjung) Sdn Bhd2015-02-12
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE (K142685)Siam Sempermed Corp., Ltd.2015-02-11
POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) (K142858)Careplus (M) Sdn Bhd2015-02-09
ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE (K140949)Ultimed Incorporated2015-02-09
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K141982)Wrp Asia Pacific Sdn. Bhd.2015-02-05
Celerity PICC Tip Confirmation System (K142889)AngioDynamics, Inc.2015-01-27
NAUTILUS DELTA (K141634)Romedex International Srl2015-01-27
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K141448)Teva Medical Ltd., Migada Plant2015-01-23
Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) (K143247)Central Medicare Sdn Bhd2015-01-22
STERISAFE HP TABLE-TOP STEAM STERILIZER (K140736)Milton E Pedrazzi D.D.S., Inc.2015-01-20
STERILUCENT STERILIZATION CONTAINER SYSTEM (K142109)Sterilucent, Inc.2015-01-20
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE (K141789)Hospira, Inc.2015-01-16
All Safe Huber Safety Infusion Set (K142590)Nexus Medical, LLC2015-01-16
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) (K142283)Yty Industry (Manjung) Sdn Bhd2015-01-16
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). (K142862)Careplus (M) Sdn Bhd2015-01-16
IV Administration (K142622)Hospira, Inc.2015-01-15
Powder-free PVC Vinyl Exam Gloves (K142703)Hebei Grandeast Plastic Products Co., Ltd.2015-01-15
Pre-vacuum Tabletop Autoclave (K143311)Tuttnauer U.S.A Co, Ltd.2015-01-15
JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K141224)Shijiazhunag Jiuyuan Plastic Co., Ltd.2015-01-15
Extension Sets (K142974)Hospira, Inc.2015-01-09
t:flex Insulin Delivery System (K143189)Tandem Diabetes Care, Inc.2015-01-09
ACCUCATH MIDLINE CATHETER SYSTEM (K142136)Vascular Pathways, Inc.2015-01-08
3M STERI-VAC STERILIZER/AERATOR (K142034)3M Company2015-01-08
Genesis Reusable Rigid Container System (K142529)Carefusion 2200, Inc.2015-01-08
ANUTRA Feedback Aspiration Syringe (K143757)Anutra Medical, Inc.2015-01-08
HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES (K141878)Tangshan Hongyun Plastic Products Co., Ltd.2014-12-24
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS (K141479)Covidien2014-12-23
Instru-Safe Instrument Protection System (K142630)Summit Medical, Inc.2014-12-23
Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142771)Xuanhua Metallurgical Industry Co., Ltd.2014-12-22
Powder Free Yellow Vinyl Patient Examination Gloves (K142508)Zibo Huaqi Trading Co., Ltd.2014-12-19
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (K141693)Advanced Sterilization Products2014-12-19
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI (K133800)Hgi Industires2014-12-19
NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142342)Nacrous Plastic Co., Ltd.2014-12-18
Snap Insulin Pump System (K142619)Asante Solutions, Inc.2014-12-18
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) (K142805)Hartalega Sdb. Bhd.2014-12-18
KIMGUARD ONE STEP STERILIZATION WRAP (K141712)Halyard Health2014-12-18
Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) (K142570)Ever Light Plastic Products Co., Ltd.2014-12-18
SMART LABEL, PROPOFOL (K142333)American I.V. Products, Inc. Dba Aiv, Inc.2014-12-18
Nitrile Powder Free Examination Glove (Blue) (K142588)Hartalega Sdn Bhd2014-12-18
BECTON DICKINSON INTELLIPORT SYSTEM (K141474)Becton, Dickinson & CO2014-12-18
Powder Free Vinyl Patient Examination Gloves (K142571)Ever Light Plastic Products Co., Ltd.2014-12-17
STERIZONE CHEMICAL INDICATOR (K141698)Tso3, Inc.2014-12-17
STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR (K141580)Tso3, Inc.2014-12-17
STERIZONE STERILIZER (K141163)Tso3, Inc.2014-12-17
InFill Graft Delivery System (K143488)Pinnacle Spine Group, LLC2014-12-17
FORT DEFIANCE AUTOMATED STEAM STERILIZER (K141009)Fort Defiance Industries, Inc.2014-12-16
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (K141513)Summit Medical, Inc.2014-12-15
ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K141303)Zhida Glove Co., Ltd.2014-12-12
YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K141304)Yongxin Healthcare Co., Ltd.2014-12-12
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe (K142620)Excelsior Medical Corporation2014-12-12
SAPPHIRE INFUSION PUMP (K141389)Q Core Medical , Ltd.2014-12-11
Bi-Portal Bone Graft Delivery Device (K142661)Spinal Surgical Strategies, LLC2014-12-11
Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) (K142343)Tangshan Hongyun Plastic Products Co., Ltd.2014-12-10
Hospira Extension Set (K142433)Hospira, Inc.2014-12-08
Vinyl Co-Polymer Powder Free Examination Gloves (K142409)Grand Work Plastic Products Co., Ltd.2014-12-05
IV ADMINISTRATION SET WITH HAND PUMP (K140838)B.Braun Medical, Inc.2014-12-05
Viscoelastic Injector (K143205)Sight Sciences, Inc.2014-12-05
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES (K141613)Zibo Goldenline Plastic Product Co., Ltd.2014-12-04
CUROS RED PORT PROTECTOR (K140657)Ivera Medical, Inc.2014-12-04
B TRAVELSAVVY SHARPS CONTAINER (K140285)Bellegrove Medical Supply, Inc.2014-12-04
HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR (K141287)Huikang Glove Co., Ltd.2014-12-03
WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K141279)Wanghui Glove Co., Ltd.2014-12-03
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR (K140589)Mesa Laboratories, Inc.2014-12-03
STERILUCENT SELF-SEAL STERILIZATION POUCH (K141412)Gs Medical Packaging, Inc.2014-12-03
Hospira Primary Sets (K142367)Hospira, Inc.2014-11-25
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE (K142270)Hartalega Sdb. Bhd.2014-11-25
SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE (K140566)Crosstex International2014-11-24
MaxZero Administration Sets (K143234)Care Fusion2014-11-20
VIAL-MATE Adaptor (K142600)Baxter Healthcare Corporation2014-11-19
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE (K141640)Shantou Wealy Medical Instrument Co.,Ltd2014-11-19
DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (K142399)Catheter Connections, Inc.2014-11-19
HEPARIN LOCK / FLUSH SYRINGES (K133446)Excelsior Medical Corporation2014-11-14
OMNIPOD INSULIN MANAGEMENT SYSTEM (K140439)Insulet Corporation2014-11-13
KIMGUARD SMART-FOLD STERILIZATION WRAP (K140963)Kimberly-Clark Corp.2014-11-10
LEAF PATIENT MONITORING SYSTEM (K141877)Leaf Healthcare, Inc.2014-11-10
YONGFA (K140246)Yongfa Glove Co., Ltd.2014-11-06
YONGHE (K140244)Yonghe Plastic Products Co., Ltd.2014-11-06
STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR (K141238)Sterilucent, Inc.2014-11-03
STERILUCENT PROCESS CHALLENGE DEVICE (K141312)Sterilucent, Inc.2014-10-31
STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER (K140464)Sterilucent, Inc.2014-10-31
T:SLIM INSULIN DELIVERY SYSTEM (K141758)Tandem Diabetes Care, Inc.2014-10-31
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION (K140940)Canadian Technical Tape, Ltd.2014-10-27
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