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General Hospital

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

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RecordFirmDate
Steam-Dot Process Indicator (K210553)Propper Manufacturing Co., Inc.2021-05-19
Turbett Instrument Pod (K202593)Turbett Surgical, Inc.2021-05-19
Disposable Latex Powder Free Examination Gloves (Non-sterile) (K201576)Pt. Universal Gloves2021-05-19
Needleless Connector (K210217)Jiangsu Caina Medical Co.,Ltd2021-05-17
NitriTec Vinyl Glove Powder Free Blue (K210460)Zhonghong Pulin Medical Products Co., Ltd.2021-05-17
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K210774)Shandong Jieshi Medical Products Co., Ltd.2021-05-14
Powder Free Vinyl Patient Examination Gloves (K210799)Yunnan Huazhiyuan Medical Technology Co., Ltd.2021-05-14
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock (K210200)Set Medikal Sanayi VE Ticaret Anonim Sirketi2021-05-14
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K210780)Shandong Shangwei Medical Products Co., Ltd.2021-05-14
Powder Free Nitrile Examination Glove (K210369)Pastel Glove Sdn Bhd2021-05-13
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, S40 Sterilant Concentrate (K210737)STERIS Corporation2021-05-12
Single-use medical poly (vinyl chloride) examination glove (K201504)Anhui Bytech Medical Supplies Co., Ltd.2021-05-10
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile (K210366)Onetexx Sdn Bhd2021-05-07
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) (K210755)Meditech Gloves Sdn Bhd2021-05-07
Karl Storz Radel Sterilization Trays (K203572)Karl Storz Endoscopy America, Inc.2021-05-07
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) (K203036)Central Medicare Sdn Bhd2021-05-07
Umbilical Vessels Catheter (K201697)Haolang Medical USA Corporation2021-05-06
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (K201936)Gilero, LLC2021-05-06
ProntoPump Sterile Tube Set (K200893)Ipax, Inc.2021-05-04
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) (K210944)Harbour Health, LLC2021-04-29
Infrared Thermometer (K203454)Shandong Zhushi Pharmaceutical Group Co., Ltd.2021-04-29
Disposable Nitrile Examination Gloves (K203436)Shandong Zhushi Pharmaceutical Group Co., Ltd.2021-04-28
MicroDose Injector (K203264)Medone Surgical, Inc.2021-04-26
Powder Free Blue Nitrile Examination Glove (K203512)Vip Glove Sdn Bhd2021-04-26
SIGMA Sterilization Pouch and Roll (K202462)Sigma Medical Supplies Corporation2021-04-23
Verifine Safety Type Insulin Pen Needle (K210065)Promisemed Hangzhou Meditech Co., Ltd.2021-04-22
Nitrile Glove Powder Free Blue (K210145)Changzhou Universal Medical Equipment Co., Ltd.2021-04-21
Disposable Nitrile Examination Gloves (K203805)Jiangsu Yanfang Medical Technology Co., Ltd.2021-04-20
Infrared Thermometer Models: DT-8806S, DT-8807S (K203170)Shenzhen Everbest Machinery Industry Co., Ltd.2021-04-16
Disposable Nitrile Gloves (K210276)Fujian Ercon Medical Management Co., Ltd.2021-04-16
BIOTECH Nitrile Examination Gloves (K202419)Tk Hitech Technology Co., Ltd.2021-04-16
SecurAcath (K210629)Interrad Medical, Inc.2021-04-12
Huber Needle Infusion Set, Safety Huber Needle Infusion Set (K200463)Jiangsu Caina Medical Co.,Ltd2021-04-07
Nitrile Examination Gloves (K210106)Zhenjiang Huayang Latex Products Co., Ltd.2021-04-07
Digital Thermometer Model T103, T104 (K201879)Bioland Technology, Ltd.2021-03-31
Blue Nitrile Exam Glove, Powder Free (K210057)Real Star Medical Technology Co., Ltd.2021-03-31
Blue Nitrile Exam Glove, Powder Free (K210058)Great Harvest Trading Co., Ltd.2021-03-30
RG 3ml Medication Cartridge (K201634)Chengdu Shifeng Medical Technology Co., Ltd.2021-03-26
AllerBlock Junior (K201734)Nasaleze International, Ltd.2021-03-26
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (K202083)Shen Wei USA, Inc.2021-03-25
NeedleSmart Professional (NS Pro) (K202073)Needlesmart Limited2021-03-25
ST-Z5 (K201878)Z-Systems AG2021-03-25
STERIZONE VP4 Test Pack (K203560)Tso3 Inc., Now A Part of Stryker2021-03-24
Safety Subcutaneous Infusion Set (K201626)Epic Medical Pte. , Ltd.2021-03-24
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color (K202080)Shen Wei USA, Inc.2021-03-24
Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 (K202009)Shenzhen Juzhong Technology Co., Ltd.2021-03-22
EZ-IO Intraosseous Vascular Access System (K202492)Teleflex Medical2021-03-22
Patient Examination Gloves (K203593)Guangdong Kingfa Sci. & Tech.Co., Ltd.2021-03-19
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue (K202081)Shen Wei USA, Inc.2021-03-19
Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid (K202082)Shen Wei USA, Inc.2021-03-17
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors (K202086)Shen Wei USA, Inc.2021-03-16
Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 (K203707)Shenzhen Zhengkang Technology Co., Ltd.2021-03-12
Vinyl Examination Gloves(Yellow) (K203666)Lutai Medical Technology Co., Ltd.2021-03-12
Groshong NXT PICC Catheter (K201452)C.R. Bard, Inc.2021-03-12
Body Infrared Thermometer HT-820D (K202591)Dongguan Xintai Instrument Co., Ltd.2021-03-09
Neodent EasyGuide Kit Cases (K203618)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2021-03-09
Infrared Thermometer (K201508)Dongguan Prestige Sporting Goods Co., Ltd.2021-03-09
iHealth Wireless No-Touch Forehead Thermometer (K202753)Andon Health Co, Ltd.2021-03-08
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors (K202076)Shen Wei USA, Inc.2021-03-05
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove (K202078)Shen Wei USA, Inc.2021-03-05
BD Intraosseous Infusion System (K203193)Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]2021-03-04
3M Attest Rapid Readout Biological Indicator, 1295 (K210277)3M Company2021-03-03
EOGas 4 Endo-SteriTest RRBI (K202879)Andersen Sterilizers, Inc.2021-03-03
Arisure Closed System Drug Transfer Device (CSTD) (K201422)Yukon Medical, LLC2021-03-02
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) (K202356)Kanglongda Vietnam Protection Technology Company Limited2021-03-02
OMNI Surgical System (K202678)Sight Sciences, Inc.2021-03-01
Nitrile Examination Gloves (Blue, Violet Blue, White) (K202402)Jiangsu Tianshuo Medical Products Co., Ltd.2021-03-01
Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes (K201533)Avinent Implant System S.L.U.2021-03-01
Getinge GSS610N Series Steam Sterilizer (K201927)Maquet GmbH2021-03-01
Medical infrared forehead thermometer (K202111)Hunan Honggao Electronic Technolofy Co., Ltd.2021-02-26
Disposable Vinyl Examination Gloves (K203439)Shandong Zhushi Pharmaceutical Group Co., Ltd.2021-02-26
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C (K203332)Hetaida Technology Co., Ltd.2021-02-25
KARL STORZ UDEL Sterilization Trays (K201945)Karl Storz Endoscopy America, Inc.2021-02-25
Infrared Forehead Thermometer (K202420)Conmo Electronic Company Limited2021-02-25
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set (K201142)Simplivia Healthcare , Ltd.2021-02-25
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim (K202003)Gmp Medicare Sdn. Bhd.2021-02-24
Molekule Air Mini, Molekule Air Mini + (K202339)Molekule, Inc.2021-02-23
Velano ExT Extension Set (K200439)Velano Vascular2021-02-23
MiniLoad Syringe (K202432)Ocuject, LLC2021-02-19
BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit (K201412)Bego Implant Systems GmbH & Co. KG2021-02-18
Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 (K202687)Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.2021-02-18
EZ-Injec LDV Sterile Safety Needle (K210444)Poonglim Pharmatech, Inc.2021-02-16
PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)Poonglim Pharmatech, Inc.2021-02-16
Infrared Thermometer (K202368)Shandong Bittel Intelligent Technology Co., Ltd.2021-02-12
Vinyl Examination Gloves (Yellow) (K203702)Xinying Trading Co., Ltd.2021-02-12
LYDUS Nitrile Examination Gloves, Powder Free (K203191)Nathan Trading Co., Ltd.2021-02-12
Panda iRes Warmer, Giraffe Warmer (K201628)GE Healthcare2021-02-12
Infrared Forehead Thermometer (K201536)Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.2021-02-10
HydroMID (K203069)Access Vascular, Inc.2021-02-08
Easydrip Pen Needle, Easydrip Plus Pen Needle (K193422)Sandstone Medical (Suzhou), Inc.2021-02-02
Standard Sterilizable Tray (K202524)Implant Direct Sybron Manufacturing, LLC2021-01-28
Non-Contact Forehead Thermometer (Models UT306H & UT308H) (K203747)Uni-Trend Technology (China) Co., Ltd.2021-01-25
BD Hypodermic Syringe (K203453)Becton, Dickinson and Company2021-01-25
Non-Contact Forehead Thermometer (UT30H) (K203656)Uni-Trend Technology (China) Co., Ltd.2021-01-22
Piccolo Medical SmartPICC System (K200037)Piccolo Medical, Inc.2021-01-22
AEROCURE-MD (K203189)Aerobiotix, Inc.2021-01-21
Precision Delivery Infusion Set (K202672)Quest Medical, Inc.2021-01-21
Nanum Syringe (K201930)Nanum Company Co., Ltd.2021-01-17
Non-contact Electronic Forehead Infrared Thermometer (K201582)Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.2021-01-15
Infrared Thermometer (K201579)Shenzhen Xunwei Industrial Co., Ltd.2021-01-15
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