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General Hospital

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

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RecordFirmDate
Allerhope Allergy Skin Tester (K162917)Procare Industrial Co., Limited2017-08-17
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) (K171118)Cair Lgl2017-08-15
3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K170321)3M Company2017-08-14
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set (K171735)C.R. Bard, Inc.2017-08-08
Supplemental Instrument Trays (K170939)Nuvasive Specialized Orthopedics, Incorporated2017-08-08
Merit Syringe (K171362)Merit Medical Systems, Inc.2017-08-07
CATHTONG II PICC Catheter (K172039)L&Z Us, Inc.2017-08-03
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (K170651)Yangzhou Medline Industry, Co., Ltd.2017-08-02
Carefusion NeutraClear Needle-free connector (K171132)Cair Lgl2017-07-31
Xingyu Nitrile Powder Free Patient Examination Gloves, White color (K171615)Shandong Xingyu Gloves Co., Ltd.2017-07-31
Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator (K163598)Advanced Sterilization Products2017-07-31
TUBETECH IV Administration Set (K162951)Douglas Medical Products, Inc.2017-07-28
3M Comply Hydrogen Peroxide Indicator Tape (K170563)3M Company2017-07-27
VacLok AT Vacuum Syringe (K163597)Merit Medical Systems, Inc.2017-07-27
VISCO 360 Viscosurgical System (K171905)Sight Sciences, Inc.2017-07-27
wireless thermometer (K170769)Ech (Changzhou) Medical Instrument Co., Ltd.2017-07-26
Orbit Inserter (K163400)Ypsomed AG2017-07-26
CT Midline (K170770)Medical Components, Inc. (dba MedComp)2017-07-25
Spinal Manometer NRFit; Spinal Manometer LUER (K170305)PAJUNK GmbH Medizintechnologie2017-07-25
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color (K162312)Shen Wei USA, Inc.2017-07-25
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST (K162858)Careplus (M) Sdn Bhd2017-07-24
3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader (K171003)3M Company2017-07-21
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color (K171616)Shandong Xingyu Gloves Co., Ltd.2017-07-20
Microlife Digital Infrared Ear Thermometer (K170219)Microlife Intellectual Property GmbH2017-07-20
CADD® Infusion Disposables Portfolio with NRFit™ connectors (K162219)Smiths Medical Asd, Inc.2017-07-20
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE (K171093)Sanrea Healthcare Products Pvt, Ltd.2017-07-19
Graftgun Universal Graft Delivery System (K170675)SurGenTec, LLC2017-07-19
MaxZero Extension Sets with Needless Connector (K171957)Carefusion 303, Inc.2017-07-19
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue (K162510)Ug Global Resources Sdn. Bhd.2017-07-18
20G x 5/8 Pro-Lock CT Safety Infusion Set (K171333)Medcomp (Dba Medical Components, Inc.)2017-07-18
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs (K170686)Brightway Holdings Sdn. Bhd.2017-07-14
SterilContainer S System (K162815)Aesculap, Inc.2017-07-13
Mini Needle (K170768)Ocuject, LLC2017-07-10
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs (K170397)Kossan International Sdn Bhd2017-07-10
DilaCheck Nitrile Powder Free Examination Glove, (Sterile) (K163035)Elm Tree Medical, Inc.2017-07-07
EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs (K171339)Eco Medi Glove Sdn. Bhd.2017-07-07
Equashield Closed System drug Transfer Device (CSTD) (K170706)Equashield Medical , Ltd.2017-07-03
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) (K170794)Hartalega NGC Sdn. Bhd.2017-06-30
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (K171533)Ahlstrom Nonwovens, LLC2017-06-29
Powder-Free Clear Vinyl Patient Examination Gloves (K170735)Zibo Yue Fan Medical Products Co, Ltd.2017-06-27
hypodermic Pinpoint™ GT Needle (K163437)C.R. Bard, Inc.2017-06-23
Gemini Sterilization Wrap (K162993)Medline Industries, Inc.2017-06-23
Babyleo TN500 (K162821)Draegerwerk AG & CO Kgaa2017-06-23
POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED (K170094)Vietglove Corporation2017-06-23
Solution Set with 1.2 Micron Air Eliminating Filter (K161808)Baxter Healthcare Corporation2017-06-21
STERRAD VELOCITY Biological Indictator and Reader (K170039)Advanced Sterilization Products (Asp)2017-06-20
Encore Neutral (K162826)Rymed Technologies, LLC2017-06-15
Alzair Allergy Blocker (K170848)Nasaleze International, Ltd.2017-06-14
CompuFlo Epidural Computer Controlled Anesthesia System (K161883)Milestone Scientific, Inc.2017-06-09
OneTouch Via On-Demand Insulin Delivery System (K163357)Lifescan Europe, A Division of Cilag GmbH2017-06-07
Digital Thermometer (K163603)Guangzhou Jinxinbao Electronic Co., Ltd.2017-06-06
Closed Male Luer (K171101)Yukon Medical2017-06-02
PowerGlide ST Midline Catheter (K170158)C.R. Bard, Inc.2017-06-01
Infusion Set for Single Use (K162601)Shinva Ande Healthcare Apparatus Co., Ltd.2017-05-31
CATHTONG II PICC Catheter (K170486)L&Z Us, Inc.2017-05-25
Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein (K170779)Terang Nusa Sdn Bhd2017-05-24
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr (K170290)Shen Wei USA, Inc.2017-05-24
LATEX EXAMINATION GLOVE POWDER FREE (K161833)Careglove Global Sdn. Bhd.2017-05-23
Powder Free Nitrile Patient Examination Gloves, Blue (K163553)Hebei Titans Medical Supply Technology Group., Ltd.2017-05-22
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow (K170575)Ever Global (Vietnam) Enterprise Corp2017-05-16
TEVADAPTOR Closed Drug Reconstitution and Transfer System (K170680)Teva Medical Ltd., Migada Plant2017-05-16
Belimed Steam Sterilizer MST-H TOP 5000 (K170228)Belimed AG2017-05-12
AIK Sterile Acupuncture Needles for Single Use (K162566)Changchun Aik Medical Devices Co., Ltd.2017-05-11
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle (K161950)Promisemed Hangzhou Meditech Co., Ltd.2017-05-11
UniTex Non-Sterile, Powder-Free, Latex Examination Glove (K161961)Ug Global Resources Sdn. Bhd.2017-05-11
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) (K170393)Zibo Chengxun Automatic Device Co., Ltd.2017-05-09
Resultz Lice & Egg Removal Kit (K151562)Piedmont Pharmaceuticals, LLC2017-05-08
VERIFY ASSERT STEAM Process Challenge Device (K162945)STERIS Corporation2017-04-28
Introcan Safety 3 Closed IV Catheter (K163358)B.Braun Melsungen AG2017-04-28
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles (K170070)STERIS Corporation2017-04-28
Self Sealing Sterilization Pouches (K162258)Tianchang Jiarui Packaging Material Co., Ltd.2017-04-28
Instrument kits (K160730)Anthogyr2017-04-27
Pro-Lock CT Safety Infusion Set (K162271)Medcomp (Medical Components, Inc.)2017-04-26
Triton Sponge System (K163507)Gauss Surgical, Inc.,2017-04-25
PowerPICC Provena Catheters with SOLO Valve Technology (K162441)C.R. Bard, Inc.2017-04-24
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K162294)Brightway Holdings Sdn. Bhd.2017-04-21
Braun No Touch + Forehead NTF3000 Thermometer (K163516)Kaz USA, Inc., A Helen of Troy Company2017-04-21
Steri-Cassette and Steri-Cage Sterilization Packaging System (K162063)Sybron Dental Specialties2017-04-21
Sterile Single-use Infusion Set (K163160)Jiangxi Hongda Medical Equipment Group , Ltd.2017-04-20
Cardinal Health Sterilization Wrap (K161910)Cardinal Health200, LLC2017-04-20
QiF Blood and Fluid Warmer (K163708)Quality IN Flow , Ltd.2017-04-20
VisioFocus Mini, VisioFocus Smart (K160680)Tecnimed S.R.L.2017-04-19
OmniPod Insulin Management System (K162296)Insulet Corporation2017-04-18
PowerFlow Apheresis I.V. Port (K163001)C.R. Bard, Inc.2017-04-17
BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle (K170386)Becton Dickinson & Company2017-04-12
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) (K163144)Gke-GmbH2017-04-07
Dual Mode Infrared Thermometer (K163256)Intelliworks, LLC2017-04-06
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (K162413)STERIS Corporation2017-03-31
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM (K162186)Brightway Holdings Sdn. Bhd.2017-03-31
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE (K162626)Top Quality Glove Sdn. Bhd2017-03-31
Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove (K161929)Dipped Products (Thailand) Limited2017-03-29
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) (K162405)Comfort Rubber Gloves Industries Sdn. Bhd.2017-03-28
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (K161469)Hospira, Inc.2017-03-28
Sapphire Infusion Pump (K161667)Q Core Medical , Ltd.2017-03-27
Freedom Syringe (K161812)Procedure Products, Inc.2017-03-27
NITRILE EXAMINATION GLOVE (K163267)Brightway Holdings Sdn. Bhd.2017-03-24
VERIFY Assert Self-Contained Biological Indicator (K162701)STERIS Corporation2017-03-24
VERIFY Incubator for Assert Self Contained Biological Indicators (K163587)STERIS Corporation2017-03-24
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (K163017)Gmp Medicare Sdn. Bhd.2017-03-22
Nix Ultra Lice Treatment Kit (K163401)Medtech Products, Inc.2017-03-21
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