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General Hospital

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

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RecordFirmDate
Digital Thermometer (K190990)Xiamen Ants Bro Technology Co., Ltd.2019-12-31
mCare® Powder Free Nitrile Black Examination Glove (K192444)Mercator Medical (Thailand), Ltd.2019-12-31
Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs (K190736)Ever Growth (Vietnam) Co. , Ltd.2019-12-23
EZ-TRAX Containment Device (K192487)K1 Medical, LLC2019-12-23
3M Attest Steam Chemical Integrator (K193254)3M Company2019-12-23
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color (K190860)Ever Growth (Vietnam) Co. , Ltd.2019-12-23
Neodent Instrument Kit Cases (K190665)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2019-12-23
Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) (K192104)Medline Industries, Inc.2019-12-23
TK Sterile Hypodermic Needle (K191643)Anhui Tiankang Medical Technology Co., Ltd.2019-12-19
Neodent Instrument Kit Cases (K192670)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2019-12-18
Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725)Riverstone Resources Sdn Bhd2019-12-17
neria guard Infusion Set (K192647)Unomedical A/S2019-12-13
Infrared Thermometer, model: PC808 (K190717)Shenzhen Pacom Medical Instruments Co., Ltd.2019-12-13
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K192929)STERIS Corporation2019-12-10
Health Line CT CVC (K192533)Health Line International Corporation2019-12-10
ID-Cap System (K183052)Etectrx, Inc.2019-12-06
Straumann Modular Cassette (K191522)Institut Straumann AG2019-12-03
mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed (K190876)Mercator Medical (Thailand), Ltd.2019-12-02
Uroject12 Syringe Lever (K190987)Urogen Pharma, Ltd.2019-12-02
Decanting Device (K182819)Gcmedica Enterprise Ltd.(Wuxi)2019-12-02
Pivot System Sterilization case (K181845)Rp Medical, Inc.2019-11-25
Infant Incubator (K190494)Ningbo David Medical Device Co., Ltd.2019-11-25
Blue Latex Examination Powder Free Gloves (K192329)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2019-11-25
3M™ Attest™ Steam Chemical Integrators (K191236)3M Company2019-11-22
SAM IO Intraosseous Access System (K191488)Sam® Medical Products, Inc.2019-11-21
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm (K190816)Avenir Performance Europeenne Medical (Apem)2019-11-19
Digital Thermometer (K183393)Joytech Healthcare Co. , Ltd.2019-11-18
3M Comply Hydrogen Peroxide Chemical Indicator (K192937)3M Company2019-11-16
Piper GO-IO Intraosseous Infusion System (K191976)Piper Access, LLC2019-11-13
Infrared Thermometer Model MD-H30 (K191570)Guangzhou Berrcom Medical Device Co., Ltd.2019-11-13
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) (K192232)Hartalega NGC Sdn. Bhd.2019-11-08
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves (K191230)O&M Halyard, Inc.2019-11-08
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K191292)Anhui Powerguard Technology Co., Ltd.2019-11-05
MTS225 and MTS300 Multiple Tray Sterilization Systems (K190541)Pmbs, LLC2019-11-05
WellDoc BlueStar (K190013)Welldoc, Inc.2019-11-04
STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) (K181993)Sturdy Industrial Co., Ltd.2019-11-01
BD Acute Central Line (K190855)Bard Access Systems, Inc. (Bard Has Joined Bd)2019-11-01
Belimed Steam Sterilizer MST-H TOP 5000 (K191896)Belimed AG2019-10-31
primeMidline Catheters (K192802)Pfm Medical, Inc.2019-10-28
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 (K192673)3M Company2019-10-28
Intraosseous infusion device (K191258)Einstein Works, LLC2019-10-23
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs (K183562)Encompass Industries Sdn. Bhd.2019-10-23
Diana ChemoClave Transfer Set (K190157)Icu Medical2019-10-23
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile (K190539)Monumedical, LLC2019-10-22
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device (K192001)Sterilucent, Inc.2019-10-22
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K192659)Insulet Corporation2019-10-21
BD Insulin Syringe (K190054)Becton, Dickinson and Company2019-10-21
Sterilucent VH2O2 Chemical Indicators (K191999)Sterilucent, Inc.2019-10-21
Infrared Forehead Thermometer (Model IR-FT) (K191668)Comper Chuangxiang (Beijing) Technology Co., Ltd.2019-10-18
Infrared Thermometer, Breeze model (K191283)Suzhou Melodicare Medical Technology Co., Ltd.2019-10-18
Quantum Blood and Fluid Warming System (K192325)Life Warmer, Inc.2019-10-18
Vial Adapter Ø20 mm (K190149)Avenir Performance Europeenne Medical (Apem)2019-10-15
Medtronic Transportation / Sterilization Cassettes (K190840)Medtronic Sofamor Danek USA, Inc.2019-10-15
Infared Thermometer (K191251)Shenzhen Calibeur Industries Co., Ltd.2019-10-15
K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall (K192057)Terumo Europe N.V.2019-10-11
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) (K182184)Mdk (Shanghai) Medical Packing Co., Ltd.2019-10-10
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (K192210)Fiab Spa2019-10-10
Instylla Delivery Kit (K191659)Instylla, Inc.2019-10-10
Halyard ONE-STEP* Sterilization Wrap (K192147)Owens & Minor (O&M) Halyard, Inc.2019-10-10
Nipro Syringe (K191359)Nipro Medical Corporation2019-10-09
NIO-I (K190538)Waismed, Ltd.2019-10-07
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (K183441)Semperit Investments Asia Pte , Ltd.2019-10-04
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe (K190183)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2019-10-04
Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe (K191490)Jiangsu Caina Medical Co.,Ltd2019-10-03
EpiFaith Syringe (K192421)Flat Medical Co., Ltd.2019-09-27
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff (K190454)Hartalega NGC Sdn. Bhd.2019-09-26
PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate (K190466)Shen Wei USA, Inc.2019-09-26
Supercath 5 (K190001)Togo Medikit Co., Ltd.2019-09-20
AccuCath Ace Intravascular Catheter (K191232)C.R. Bard, Inc.2019-09-18
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim (K191800)Kossan International Sdn Bhd2019-09-16
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe (K191378)Medline Industries, Inc.2019-09-15
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye (K191021)Terragene S.A.2019-09-13
Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (K190005)Sterilucent, Inc.2019-09-13
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use (K190002)Shanghai Kohope Medical Devices Co., Ltd.2019-09-12
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector (K183444)Cenorin, LLC2019-09-09
Sure-Fine Insulin Syringes (K191531)Shina Med Corporation2019-09-06
Reusable Temperature Probe (K182751)Shenzhen Caremed Medical Technology Co., Ltd.2019-09-06
Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs (K190403)Ever Global (Vietnam) Enterprise Corporation2019-09-06
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use (K183665)Jiangsu Micsafe Medical Technology Co., Ltd.2019-09-06
bili-hut (K190899)Little Sparrows Technologies, Inc.2019-09-05
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (K191343)STERIS Corporation2019-09-05
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label (K192020)STERIS Corporation2019-09-05
Dual-Safety Pen Needle (K191853)Promisemed Hangzhou Meditech Co., Ltd.2019-09-05
Advocate Non-Contact Infrared Thermometer (K191004)Broadmaster Biotech, Corp.2019-09-05
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe (K182765)Top Corporation2019-09-03
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate (K191475)Nobel Biocare AB2019-08-29
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink (K182382)Gmp Medicare Sdn Bhd (F25)2019-08-29
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch (K183356)Weihai Xingtai Packaging Products Co., Ltd.2019-08-19
HCT Empty EVA Container Pack (K190328)Health Care Technologies2019-08-15
PowerFlow Implantable Apheresis IV Port (K191143)C.R. Bard, Inc.2019-08-02
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape (K191741)Intertape Polymer, Inc.2019-08-02
Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs (K182089)Platinum Glove Industries Sdn. Bhd.2019-07-30
Bonus Therapeutics Mixing and Delivery System (K190996)Bonus Therapeutics , Ltd.2019-07-28
Infrared Ear/Forehead Thermometer (K190873)Joytech Healthcare Co. , Ltd.2019-07-26
STATCLAVE G4 Chamber Autoclave (K190062)Scican , Ltd.2019-07-26
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs (K183280)Smart Glove Corporation Sdn. Bhd.2019-07-26
Powder-Free Vinyl Patient Examination Gloves, Yellow Color (K191092)Anhui Intco Medical Products Co., Ltd.2019-07-22
STERIZONE(R) VP4 Sterilizer (K190260)Tso3, Inc.2019-07-19
Immucise (K190427)Terumo Corporation2019-07-18
Microlife Digital Infrared Ear Thermometer (K183663)Microlife Intellectual Property GmbH2019-07-16
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