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General Hospital

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

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RecordFirmDate
AirKEE T900 (K232642)Healkee Medical Pte, Ltd.2024-05-23
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 (DEN230068)3M Company2024-05-21
ProSeal™ Injection Site Extended Male Luer Lock (422140) (K240433)Epic Medical Pte. , Ltd.2024-05-21
Disposable Vinyl Examination Gloves (K241252)Anqing Pukang Medical Technology Co., Ltd.2024-05-20
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets (K232793)Zevex, Inc.2024-05-17
AirKEE P900 (K232933)Healkee Medical Pte, Ltd.2024-05-16
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) (K232614)Sri Trang Gloves (Thailand) Public Company Limited2024-05-13
Filter Needle for Single Use (K233277)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-05-10
Disposable infusion set with needle (K232475)Shandong Zhushi Pharmaceutical Group Co., Ltd.2024-05-10
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) (K234039)Lexington Medical, Inc.2024-05-07
Vial2Bag Advanced® 20mm Admixture Device (K240940)West Pharmaceutical Services, Inc.2024-05-03
Vial Adapter with Filter (K233284)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-05-01
Black Pearl Nitrile Examination Glove (K232319)Ug Global Resources Sdn. Bhd.2024-04-22
AccuCath Ace™ Intravascular Catheter (K233106)Bard Access Systems, Inc. (C.R. Bard, Inc.)2024-04-19
Celerity Chemical Indicator for enspire 3000 CLCSPS (K240032)STERIS Corporation2024-04-17
nextaro® v, 20/20 (K240748)Sfm Medical Devices GmbH2024-04-16
Disposable Extension Set (K222766)Shandong Ande Healthcare Apparatus Co., Ltd.2024-04-12
Medical electronic thermometer (FC01, FC02) (K240109)Zhuzhou Goldenhot Medical Technology Co., Ltd.2024-04-12
CELERITY HP Indicator Tape (K240760)Steris2024-04-10
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K240021)Yue Kang Anhui Medical Products Co., Ltd.2024-04-08
ACTIV™ Cap (K223914)Cleansite Medical, Inc.2024-04-05
Wireless Smart Thermometer (K233192)Famidoc Technology Company Limited2024-04-05
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (K232103)Terragene S.A.2024-04-05
Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (K233026)Midmark Corporation2024-04-04
Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) (K240361)Hebei Titans Hongsen Medical Technology Co., Ltd.2024-04-04
Digital Thermometer (K230889)Wenzhou Yosun Medical Technology Co.,Ltd2024-04-03
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K240080)Syntex Healthcare Products Co., Ltd.2024-04-02
Sepsis ImmunoScore (DEN230036)Prenosis, Inc.2024-04-02
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) (K233990)Shandong Xingyu Gloves Co., Ltd.2024-04-01
Novum IQ Large Volume Pump (K211122)Baxter Healthcare Corporation2024-03-29
Dose IQ Safety Software (K230665)Baxter Healthcare Corporation2024-03-29
ProSeal™ Injector Plus (Model no. 421050) (K240171)Epic Medical Pte. , Ltd.2024-03-28
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K234097)Ever Growth (Vietnam) Corporation Limited2024-03-27
Removal System Large Bore 60 cc Syringe (K233069)Inari Medical, Inc.2024-03-26
Dukal SMS Sterilization Wrap (K233262)Dukal, LLC2024-03-22
BAHADIR STERILIZATION CONTAINERS (K233578)Bahadir USA, LLC2024-03-22
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (K231938)O&M Halyard, Inc.2024-03-22
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) (K232654)Nephron Nitrile, LLC2024-03-20
HWJECT Auto-disable syringe (K234024)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2024-03-19
ivWatch® Model 400 (K233881)Ivwatch, LLC2024-03-15
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) (K231856)Medexel Co.,Ltd2024-03-15
Nouvo Safety Set (K232234)Poly Medicure Limited2024-03-15
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (K233814)3M Company2024-03-15
STERiJECT Low Dead Space, STERiJECT The Invisible Needle (K231734)Tsk Laboratory International Japan KK2024-03-08
Insulin Syringe (K233794)Spm Medicare Pvt. , Ltd.2024-03-06
BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device (K233021)Care Fusion2024-03-06
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves (K231365)Anhui Intco Medical Products Co., Ltd.2024-03-01
Insignis™ Syringe Infusion System (K232328)Innovative Health Sciences, LLC2024-03-01
DEKA Infusion System, DEKA Administration Set (K232316)Deka Research and Development2024-03-01
Probe Covers (YF-001, YF-002) (K240023)Shenzhen YI Fang Blister Packaging Co., Ltd.2024-03-01
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K240051)Lingshi Hongruida Health Protection Technology Co., Ltd.2024-02-29
Praxiject™ SP 0.9% NaCl (K233623)Medxl, Inc.2024-02-27
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (K233560)Eco Medi Glove Sdn. Bhd.2024-02-26
Airgle Room Air Purifier (K232645)Airgle Corporation2024-02-16
Medline Luer Lock Syringes (K230235)Medline Industries, LP2024-02-16
SCIg60 Infusion System (K240148)Emed Technologies Corporation2024-02-16
Black Nitrile Powder Free Patient Examination Glove, Non Sterile (K233740)W.A. Rubbermate Co., Ltd.2024-02-13
Infrared Thermometer: Model YJ600 (K232473)Zhuhai Yueja Medical Device Technology Co., Ltd.2024-02-09
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (K240072)Luliang Hongruida Health Protection Technology Co., Ltd.2024-02-09
Lexa MINI (RIS-303, RIS-305) (K233504)W&H Sterilization S.R.L.2024-02-08
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232764)Eco Medi Glove Sdn. Bhd.2024-02-07
VitalDetect (K231625)Wellvii, Inc.2024-02-02
Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles (K232165)Berpu Medical Technology Co., Ltd.2024-02-01
Digital Thermometer, Model T28, T28L (K232678)Guangdong Genial Technology Co., Ltd.2024-01-31
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K233598)Anhui Intco Medical Products Co., Ltd.2024-01-26
Mix2Vial® Transfer Device (K231071)West Pharma. Services IL, Ltd.2024-01-19
CeQur Simplicity™ On-Demand Insulin Delivery System (K233447)Cequr SA2024-01-18
Washtrays (K231144)Dentsply Sirona2024-01-16
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K233970)Nephron Nitrile, LLC2024-01-16
SoloSmart Injection Pen Adapter (SoloSmart®) (K231820)Biocorp Production2024-01-12
SMB Luer lock disposable syringe (K231558)Smb Corporation of India2024-01-12
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (K233520)Anhui Powerguard Technology Co., Ltd.2024-01-12
ToxiSeal Vial Adapter with External Balloon (K222929)Epic Medical Pte. , Ltd.2024-01-11
SurgiCount+ System (K232250)Stryker Instruments2024-01-11
Carecube Negative Pressure Isolation Chamber (K231256)Carecubes, Inc.2024-01-03
ResQ Administration Set (K231707)Q For Plastic Industries2024-01-03
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim (K233405)Eco Medi Glove Sdn. Bhd.2023-12-28
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 (K232338)Alicn Medical Shenzhen, Inc.2023-12-22
Anthogyr INTEGRAL Guided Surgery Cassettes (K233264)Anthogyr2023-12-22
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (K233132)Primus Sterilizer Company, LLC2023-12-19
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) (K233182)Zibo Kaiyue Mould Technology Co., Ltd.2023-12-15
ConFirm 20 Minute Incubator (K233681)STERIS Corporation2023-12-15
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE (K233682)STERIS Corporation2023-12-15
Body Temperature Software (BTS) (DEN230050)Fitbit, LLC2023-12-15
Vial Adapter 20mm (K232875)West Pharma. Services IL, Ltd.2023-12-14
Sterile Hypodermic Needles for Single Use (K233037)Zhejiang Kindly Medical Device Co., Ltd.2023-12-12
Aygün Sterilization Container Systems (K233222)Aygun Surgical Instruments Co., Inc.2023-12-12
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port (K232737)Bard Peripheral Vascular, Inc.2023-12-08
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems (K233654)Steris2023-12-08
Reliance® Fusion Sterilization Wraps (K230137)Ahlstrom-Munksjo Nonwovens, LLC2023-12-07
Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K233042)Shandong Intco Medical Products Co, Ltd.2023-12-06
THERMOCLICK (K222057)T&R BIOFAB CO., Ltd.2023-12-05
CATHTONG III Tapered PICC Catheter (K233149)L&Z Us, Inc.2023-12-01
Vial2Bag Advanced® 13mm Admixture Device (K230988)West Pharma. Services IL, Ltd.2023-12-01
Extension Set (K230528)Medcaptain Life Science Co., Ltd.2023-12-01
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K233529)Becton Dickinson Infusion Therapy Systems, Inc.2023-12-01
NavaClick Injection System (K231877)Lineage Biomedical, Inc.2023-11-30
Insulin Syringe (K230061)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2023-11-30
L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters (K230669)Argon Medical Devices2023-11-30
VersaPump Infusion System (K230883)Emed Technologies Corporation2023-11-28
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