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General Hospital

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

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RecordFirmDate
Non Sterile Powder Free Latex Examination Glove (K221667)New Era Medicare Sdn. Bhd.2022-10-28
JR MEDIC (K222348)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2022-10-27
S.I.N. Instrument Kits (K222514)S.I.N. – Sistema DE Implante Nacional S.A.2022-10-27
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (K221374)Hebei Titans Hongsen Medical Technology Co., Ltd.2022-10-26
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) (K223235)Pt. Sintong Unigolden Glove2022-10-26
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) (K222498)Humanwell Healthcare Group Medical Supplies Co., Ltd.2022-10-26
JR MEDIC Nitrile Examination Gloves Powder Free- Black (K221169)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2022-10-25
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) (K222349)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2022-10-21
AccuSert Needle Inserter (K213429)Emed Technologies Corporation2022-10-20
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple (K220992)Ever Global (Vietnam) Enterprise Corporation2022-10-19
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid (K222298)Onetexx Sdn Bhd2022-10-18
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile (K222721)Safeskin Retailing (Hk) Limited2022-10-18
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle (K221308)Jiangxi Maidikang Medical Devices Co., Ltd.2022-10-17
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves (K222074)Zibo Langu New Material Technology Co., Ltd.2022-10-17
SafeBreak Vascular (K222791)Lineus Medical, LLC2022-10-16
Safety Insulin Pen Needles (K213183)Zhejiang Kindly Medical Devices Co., Ltd.2022-10-14
BD Surgiphor™ Antimicrobial Irrigation System (K221504)Bd2022-10-14
SCIg60 Infusion System (K222087)Emed Technologies Corporation2022-10-13
MOST-T Autoclave (K220102)Shinva Medical Instrument Co., Ltd.2022-10-12
Sol-M Luer Lock Syringe (K222744)Sol-Millennium Medical, Inc.2022-10-11
Disposable Vinyl Examination Gloves (K223008)Jiangxi Handspro Products Solutions Co., Ltd.2022-10-08
AMSafe NeuFlo Needleless Connector (K220267)Amsino International, Inc.2022-10-07
SteriTite Container System with MediTray Parts (K221492)Case Medical, Inc.2022-10-07
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs (K222714)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-10-07
Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization (K220057)Shinva Ande Healthcare Apparatus Co., Ltd.2022-10-07
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 (K221170)Shenzhen AOJ Medical Technology Co., Ltd.2022-10-07
Gemini Sterilization Wrap (K220365)Medline Industries, LP2022-10-06
Sterile Hypodermic Syringes for Single Use with Safety Needles (K221073)Sichuan Prius Biotechnology Co., Ltd.2022-10-04
Sterile Safety Hypodermic Needles for Single Use (K221080)Sichuan Prius Biotechnology Co., Ltd.2022-10-04
Sterile Hypodermic Syringes for Single Use with Needles (K221068)Sichuan Prius Biotechnology Co., Ltd.2022-10-04
Sterile Hypodermic Needles for Single Use (K221066)Sichuan Prius Biotechnology Co., Ltd.2022-10-04
Sterile Hypodermic Syringes for Single Use (K221079)Sichuan Prius Biotechnology Co., Ltd.2022-10-04
PCA Syringe Sets (K212262)Baxter Healthcare Corporation2022-10-03
Disposable Nitrile Examination Glove (K222937)Jiangsu Cureguard Glove Co., Ltd.2022-10-01
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (K221378)Tec Gloves Industry (M) Sdn.Bhd.2022-09-30
S.I.N. Instrument Kits (K222005)S.I.N. - Sistema DE Implante Nacional S.A.2022-09-29
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 (K222615)STERIS Corporation2022-09-28
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) (K222442)Anhui Bytech Medical Supplies Co., Ltd.2022-09-28
SteriCUBE® Multiple Tray Sterilization Systems (K222328)Stericube, LLC2022-09-28
Infrared thermometer (K221211)Shenzhen Yolanda Technology Co., Ltd.2022-09-27
Flowart (K221473)Asset Medikal Tasarim As.2022-09-26
Betel Gloves Nitrile Examination Glove Powder Free (K222342)Betel Care Sdn. Bhd.2022-09-24
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid (K222294)Onetexx Sdn Bhd2022-09-24
Single-use medical latex examination gloves (LG100) (K222693)Fitone Latex Products Co., Ltd. Guangdong2022-09-24
Powder Free Nitrile Examination Glove (K212751)Dainam Glove Joint Stock Company2022-09-24
Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color (K221887)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-09-24
3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 (K222152)3M Company2022-09-23
NeutrArt (K221481)Asset Medikal Tasarim As.2022-09-23
Irrisept Antimicrobial Wound Lavage (K222804)Irrimax Corporation2022-09-22
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 (K221227)Tuttnauer , Ltd.2022-09-20
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) (K214056)Mezorrison Medical Technology (Dongying) Co., Ltd.2022-09-20
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) (K222642)Inner Mongolia Cureguard Medical Technology Co., Ltd.2022-09-20
Promisemed X-Safety Pen Needle (K220129)Promisemed Hangzhou Meditech Co., Ltd.2022-09-19
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe (K213013)Jeil Tech Co., Ltd.2022-09-19
Tempo Smart Button (K212217)Eli Lilly and Company2022-09-16
Nitrile Patient Examination Gloves, Powder Free (K220697)Lalan Rubbers (Pvt), Ltd.2022-09-15
SafePort(TM) Manifold (or Stopcock) (K211204)Elcam Medical Acal2022-09-15
Qorda QD1 (K220990)Winix, Inc.2022-09-14
MagiCath II (K210929)Woo Young Medical Co., Ltd.2022-09-13
Infrared Forehead Thermometer (K220084)Qingdao Yasee Medical Device Co., Ltd.2022-09-12
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays (K222440)Steris2022-09-09
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System (K222093)Steris2022-09-09
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) (K220859)Careglove Global Sdn. Bhd.2022-09-09
Spectrum IQ Infusion System with Dose IQ Safety Software (K222048)Baxter Healthcare Corporation2022-09-06
Arrow Pressure Injectable Midline Catheter (K213855)Arrow International, LLC Subsidiary of Teleflex Incorporated2022-09-02
Soteria Bed Barrier (K201876)Trinity Guardion2022-09-01
Vented Vial Adapter 20mm (K213513)West Pharma. Services IL, Ltd.2022-08-31
JR Medic (K221157)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2022-08-30
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use (K212846)Jiangsu Jichun Medical Devices Co., Ltd.2022-08-30
Dose IQ Safety Software (K211124)Baxter Healthcare Corporation2022-08-30
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl (K221164)Hong Seng Gloves Sdn Bhd2022-08-30
Novum IQ Syringe Pump (K211125)Baxter Healthcare Corporation2022-08-30
Leaderflex Mini and Leaderflex Nano (K212370)Vygon USA2022-08-29
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) (K222449)Better Care Plastic Technology Co., Ltd.2022-08-27
Nitrile Exam Gloves (Blue, Black) (K221143)Hebei Astro Medical Supply Co., Ltd.2022-08-25
Disposable, vinyl examination gloves, Yellow (K220055)Dezhou Hengchang Medical Technology Co., Ltd.2022-08-25
Iconic Latex Glove (K221648)Iconic Medicare Sdn Bhd2022-08-25
Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly (K222232)Bard Access Systems, Inc.2022-08-24
ivWatch Model 400 (K222212)Ivwatch, LLC2022-08-24
Safety Insulin Syringes (K220061)Berpu Medical Technology Co., Ltd.2022-08-23
Disposable Medical Safety Hypodermic Needle (K220603)Hantech Medical Device Co., Ltd.2022-08-23
VPS Rhythm DLX Device with TipTracker Technology (K220363)Arrow International, LLC (A subsidiary of Teleflex, Inc.)2022-08-22
SurGuard3 Safety Hypodermic Needle (K212095)Terumo Europe N.V.2022-08-22
Powder Free Latex Examination Glove, Non-Sterile (K211601)Wrp Asia Pacific Sdn. Bhd.2022-08-22
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices (K212525)Advcare Medical2022-08-19
Lexa PLUS RIS-311 (K213758)W&H Sterilization S.R.L.2022-08-19
Jeesung Safety Syringe and Single Use Needles (K212518)Jeesung Medical Co., Ltd.2022-08-18
Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle (K212033)Shandong Zhushi Pharmaceutical Group Co., Ltd.2022-08-17
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution (K213937)O&M Halyard, Inc.2022-08-16
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System (K202461)Smisson-Cartledge Biomedical, LLC2022-08-12
InstaFill Graft Delivery System, SIGNIFY Bioactive (K221737)Globus Medical, Inc.2022-08-11
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White (K212482)Sri Trang Gloves (Thailand) Public Company Limited2022-08-09
Pro Guard Nitrile Powder Free Examination Glove (K213934)Medical Glove Co., Ltd.2022-08-06
Powder Free Chloroprene Examination Glove Coloured (Blue, Green) (K213993)Careglove Global Sdn. Bhd.2022-08-05
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) (K221350)Rubberex Alliance Products Sdn Bhd2022-08-05
Solidence Multipockets (K191131)Solidence Surgical Corporation2022-08-03
Consolidated HC Steam Sterilizer (K220736)Consolidated Machine Corp.2022-08-01
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K213929)O&M Halyard, Inc.2022-08-01
Disposable Medical Nitrile Examination Gloves (K220237)Fujian Jixiang Medical Technology Co.,Ltd2022-08-01
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid (K221773)Onetexx Sdn Bhd2022-07-30
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