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General Hospital

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

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RecordFirmDate
Symmetry Surgical Quad-Lock Container System (K152111)Symmetry Surgical, Inc.2016-04-14
Nitrile Patient Examination gloves, Powderfree, Blue color (K143477)Primus Gloves Pvt Limited2016-04-14
Orbit Infusion Set (K150921)Ypsomed AG2016-04-12
LifeCare PCA Infusion System (K143612)Hospira, Inc.2016-04-08
BD FlowSmart Set, MiniMed Pro-Set (K160651)Becton, Dickinson and Company2016-04-07
Extension Set (K153293)B.Braun Medical, Inc.2016-04-06
HG Pro Nitrile Powder Free Examination Gloves (K152479)Healthy Glove Co., Ltd.2016-04-04
SMARTez elastomeric infusion pump (K151650)Epic Medical Pte. , Ltd.2016-04-04
0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe (K153481)Becton, Dickinson and Company2016-04-04
Powder Free Blue Nitrile Examination Glove (K153562)Vietglove Corporation2016-04-01
Infrared Ear Thermometer (K153146)Sejoy Electronics & Instruments Co., Ltd.2016-03-31
Halyard Black-Orange Powder-Free Nitrile Exam Glove (K153708)Halyard Health2016-03-31
ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY (K152969)Conmed Corporation2016-03-31
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) (K151997)Hartalega NGC Sdn. Bhd.2016-03-31
Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) (K152640)Fudakang Industries Co., Ltd.2016-03-28
U&U Insulin Syringe with/without Safety Retractable Device (K152808)U&U Medical Technology Co, Ltd.2016-03-25
STERIZONE VP4 Sterilizer (K153392)Ts03, Inc.2016-03-24
VDT985US Vicks SmartTemp Thermometer (K152975)Kaz USA, Inc., A Helen of Troy Company2016-03-23
Glide-On Vinyl Examination Gloves (K151754)Medline Industries, Inc.2016-03-22
Powder Free Polychloroprene Examination Glove Green (K153510)Terang Nusa Sdn Bhd2016-03-21
Genesis Low Temperature Reusable Rigid Container System (K153554)Carefusion 2200, Inc.2016-03-21
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color (K152707)Minghao Medical Products Co., Ltd.2016-03-17
Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color (K152705)Jiayuan Medical Products Co., Ltd.2016-03-17
Sungshim Insulin Pen Needle (K152334)Sung Shim Medicare Co., Ltd.2016-03-17
Giraffe OmniBed Carestation CS1 (K152814)Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company2016-03-17
Dignity Dual Port (K153238)Medcomp ( Medical Components)2016-03-15
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System (K160374)Tangent Medical Technologies, Inc.2016-03-11
Rapicide PA High-Level Disinfectant Test Strips (K152394)Medivators, Inc.2016-03-11
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color (K152720)Xingda Medical Products Co., Ltd.2016-03-10
Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712)Zhonghong Pulin Medical Products Co., Ltd.2016-03-09
MEDT PEN NEEDLE (K152824)Shandong Caremed Medical Products Co., Ltd.2016-03-07
IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) (K152402)Securus,Inc2016-03-04
Family of Steam Sterilizers B 28 series (K151597)Cefla S.C.2016-03-04
Pencylcap (K152050)B.Braun Melsungen AG2016-03-02
Braun Thermoscan PRO 6000 Ear Thermometer (K152748)Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)2016-03-01
Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves (K152719)Xinfu Medical Products Co., Ltd.2016-03-01
BCR-30-min BI™ and RBIP-ST30™ Readout Accessory (K151482)Bcr Diagnostics, Inc.2016-02-26
HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR (K152715)Haining Medical Products Co., Ltd.2016-02-25
LATEX EXAMINATION GLOVE POWDER FREE (K152593)Careplus (M) Sdn Bhd2016-02-25
IV-eye (K152088)Novarix Limited2016-02-24
APEX Compounding System Transfer Set (K151423)B.Braun Medical, Inc.2016-02-19
Powder Free Nitrile Patient Examination Gloves, Blue Color (K151680)Suqian Xingye Glove Co,Ltd2016-02-12
ivWatch Model 400 (K153605)Ivwatch, LLC2016-02-11
Safe Block Pen Needle (K151311)Artsana S.P.A2016-02-10
Electronic Thermometer (K152739)Guangdong Biolight Meditech Co., Ltd.2016-02-09
Powder Free Nitrile Patient Examination Gloves, Black color (K152271)Suqian Xingye Glove Co,Ltd2016-02-09
M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) (K152743)Microline Surgical, Inc.2016-02-08
Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue (K153028)Zibo Huiying Medical Products, Co. , Ltd.2016-02-05
Amecath Peripheral inserted Central Venous Catheter Sets (K152819)Ameco Medical Industries2016-02-05
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS (K153487)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-02-04
Top Fine Pen Needle (K152410)Medexel Co.,Ltd2016-02-02
CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC (K153423)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-01-28
Vinyl patient examination glove, Powder Free (K153159)Xingyuan Plastic Products Co., Ltd.2016-01-26
Ellipse Supplemental Instrument Trays (K151594)Ellipse Technologies, Incorporated2016-01-25
Medtronic Transportation/Sterilization Cassettes (K152241)Medtronic Sofamor Danek USA, Inc.2016-01-20
Hospira Extension Sets (K151969)Icu Medical, Inc.2016-01-19
PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) (K152669)Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std2016-01-15
DISPOSABLE THERMOMETER PROBE SHEATHS (K152690)Pinghu Sama Medical Packing Co., Ltd.2016-01-15
Turbett Surgical Container (K153025)Turbett Surgical, LLC2016-01-14
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (K151725)Advanced Sterilization Products2016-01-13
Endoscope Sterilization Tray (K151450)Intuitive Surgical, Inc.2016-01-12
Giraffe Incubator Carestation CS1 (K152809)Ohmeda Medical, A Division of Datex-Ohmeda, Inc.2015-12-31
Ageless Health Medical Digital Thermometer (K152508)Dongguan Ageless Health Industrial Co., Ltd.2015-12-31
HumanPen Ergo II (K151686)Eli Lilly and Company, Inc.2015-12-30
Navigator Aesthetic Delivery System (K151255)Carticept Medical, Inc.2015-12-30
Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray (K152951)Paragon Medical, Inc.2015-12-28
Solution Administration Sets with 0.2 Micron Filter (K153158)Baxter Healthcare Corporation2015-12-28
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs (K152542)Riverstone Resources Sdn Bhd2015-12-24
Powder Free Vinyl Patient Examination Glove (Non?-Sterile) (K150934)Lpl (Hui Zhou) Glove2015-12-21
Cardinal Health Sterilization Wrap (K151445)Cardinal Health200, LLC2015-12-21
Powder Free Vinyl Patient Examination Gloves (Green) (K152692)Supermax Plastic Products Co., Ltd.2015-12-21
Sterisheet Sterilization Wrap (K152291)Andersen Sterilizers, Inc.2015-12-17
BD FlowSmart Set, MiniMed Pro-Set (K153257)Becton, Dickinson and Company2015-12-11
AccuCath Intravascular Catheter (K153298)C.R. Bard, Inc.2015-12-10
Merit 20 mL Syringe (K152783)Merit Medical Systems, Inc.2015-12-07
KIRO Set (K152441)Kiro Robotics S.L.2015-12-04
NMI Port, NMI Port II (K153228)Navilyst Medical, Inc.2015-12-04
Universal Spike (K150787)B.Braun Medical, Inc.2015-12-02
3M Attest Rapid Readout Biological Indicator 1295 (K152060)3M Company2015-12-01
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K151679)Heze Yuze Glove Co., Ltd.2015-11-27
Arrow Endurance Extended Dwell Peripheral Catheter System (K152272)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2015-11-23
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters (K150514)C.R. Bard, Inc.2015-11-20
Gemini Sterilization Wrap (K150698)Medline Industries, Inc.2015-11-20
AN1087 Dosimeter (K150645)Andersen Sterilizers, Inc.2015-11-19
Tyvek Sterilization Pouches with Chevron Seal (K152058)Andersen Sterilizers, Inc.2015-11-18
AN85/AN86 EO Indicators (K150644)Andersen Sterilizers, Inc.2015-11-18
EOGas 4 Ethylene Oxide Gas Sterilizer (K150646)Andersen Sterilizers, Inc.2015-11-18
Andersen EOGas 4 SteriTest (K151585)Andersen Sterilizers, Inc.2015-11-18
Clickfine AutoProtect Pen Needle (K152514)Ypsomed AG2015-11-18
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K151682)Daxwell, LLC2015-11-17
Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) (K150612)Anhui Anyu Latex Products Co., Ltd.2015-11-16
MEDLINE SHARPS CONTAINERS (K143693)Medline Industries, Inc.2015-11-06
Equashield Closed System drug Transfer Device (CSTD) (K150219)Equashield Medical , Ltd.2015-11-05
Safety Auto-Disable Syrine with Needle (Auto-Lock) (K143497)Guangdong Intmed Medical Appliance Co., Ltd.2015-11-04
EXELINT SecureTouch Safety Hypodermic Needle (K152183)Exelint International, Co.2015-11-02
Cardinal Health Sterilization Wrap (K151788)Cardinal Health200, LLC2015-10-30
STERRAD CYCLESURE 24 Biological Indicator (K151971)Advanced Sterilization Products2015-10-29
Wire Sterilization Package with Indicators (K143117)American Orthodontics2015-10-29
INSTRUMENT CASSETTE (EFCCL1-F) (K141854)Osung Mnd Co., Ltd.2015-10-29
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK (K151836)Hartalega NGC Sdn. Bhd.2015-10-21
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