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General Hospital

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

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RecordFirmDate
Infrared Thermometer, Model: IR8807 (K223037)Shen Zhen Rong Feng Technology Co., Ltd.2023-07-21
BD Alaris™ Pump Epidural Infusion Set (K221319)Care Fusion2023-07-21
BD Alaris™ Pump Infusion Sets (K221327)Care Fusion2023-07-21
BD Alaris System with Guardrails Suite MX v12.1.2 (K211218)Carefusion 303, Inc.2023-07-21
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K231021)Kimberly-Clark Corporation2023-07-21
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims (K230875)Central Medicare Sdn Bhd2023-07-20
FMT Reusable Temperature Probes (K213100)Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti2023-07-18
Hypodermic Syringes & Needle (K222925)Lifelong Meditech Private Limited2023-07-18
Avitus® DragonWing Large Volume Autograft Delivery System (K231456)Avitus Orthopaedics, Inc.2023-07-17
Revital-Ox PAA High Level Disinfectant Chemical Indicator (K230558)STERIS Corporation2023-07-17
Praxiject™ 0.9% NaCl (K231754)Medxl, Inc.2023-07-13
Anthogyr Surgical Cassettes (K230680)Anthogyr2023-07-11
BT-001 (DEN220058)Better Therapeutics2023-07-07
Complement Kit Cases (K230804)JJGC Indústria e Comércio de Materiais Dentários S.A.2023-07-07
MemorialTM Gloves (K231740)Us Glove Supply2023-07-04
e-Celsius Medical System (K210924)Bodycap2023-06-28
NobelZygoma PureSet™ Tray (K231219)Nobel Biocare Services AG2023-06-27
Avitus® Precision Autograft Delivery System (K230492)Avitus Orthopaedics, Inc.2023-06-26
Mais Central Venous Catheter (K221827)Saudi Mais Co. For Medical Products2023-06-23
Surflo Winged Infusion Set (K221411)Terumo Medical Products (Hangzhou) Co., Ltd.2023-06-23
Sturdy Autoclave Super Microm (K231489)Sturdy Industrial Co., Ltd.2023-06-21
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) (K223376)Cardinal Health200, LLC2023-06-21
NC° Thermometer (Gen 3), Model Number: NCTG3 (K223522)Xiamen Intretech, Inc.2023-06-20
Volumat Polyethylene I.V. Administration Set (K221121)Fresenius Kabi2023-06-16
Neoasis (DEN220048)Invictus Medical, Inc.2023-06-16
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 (K222906)Ningbo Maxcon Medical Technology Co., Ltd.2023-06-16
Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack (K223717)STERIS Corporation2023-06-15
Celerity Incubator (K223715)STERIS Corporation2023-06-15
UTC 3mL Medication Cartridge (K230718)Gilero, LLC2023-06-15
ERBEJET® 2 System (K231023)Erbe Elektromedizin GmbH2023-06-15
Synexis Sphere Rx (K221540)Synexis, LLC2023-06-14
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) (K230573)Kossan International Sdn Bhd2023-06-13
DJF Intravascular Administration Set (K230992)Yangzhou Wei DE LI Trade Co., Ltd.2023-06-09
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K230779)Shanxi Hongjin Plastic Technology Co., Ltd.2023-06-09
Promisemed Safety Huber Needle (K230715)Promisemed Hangzhou Meditech Co., Ltd.2023-06-08
Infrared Thermometer (K222248)Alicn Medical Shenzhen, Inc.2023-06-07
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K231349)Nephron Nitrile, LLC2023-06-06
APOLLO ADVANTAGE Nitrile Examination Gloves (K230633)Dell Corning Corporation2023-06-05
Fluido Compact Blood and Fluid Warming System (K211618)The Surgical Company International B.V.2023-06-05
Volumat Line (K220301)Fresenius Kabi2023-06-02
Pen Needle (K230635)Jiangsu Caina Medical Co.,Ltd2023-06-02
Tristel Duo ULT (DEN220041)Tristel Solutions Limited2023-06-02
RGS; RGS Mini (K222702)Genesis Air, Inc.2023-06-02
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) (K222905)Ningbo Maxcon Medical Technology Co., Ltd.2023-06-01
Disposable Nitrile Gloves (ABC-DG01) (K230542)Huizhou Anboson Technology Co., Ltd.2023-05-31
FEELject LDV (Low dead volume) syringe (K213010)Feeltech Co., Ltd.2023-05-31
First Glove Blue Nitrile Examination Gloves Powder Free (K230958)First Glove Sdn. Bhd.2023-05-30
Babyroo TN300 (K230278)Draeger Medical Systems, Inc.2023-05-30
Blue Nitrile Examination Gloves Powder Free (K230601)Latrile Gloves Private Limited2023-05-28
Sweden & Martina Surgical Trays (K222640)Sweden & Martina S.P.A.2023-05-26
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K231169)Plasmapp Co,., Ltd.2023-05-25
Armis VeriCyn Wound Wash (K220759)Armis Biopharma, Inc.2023-05-25
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle (K222852)Nipro Medical Corporation2023-05-25
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System (K222311)Circa Scientific, Inc.2023-05-25
Green Non Sterile Powder Free Nitrile Examination Gloves (K230564)Central Medicare Sdn Bhd2023-05-23
MixJect® Transfer Device (K230464)West Pharma. Services IL, Ltd.2023-05-22
SafeBreak® Vascular (K223486)Lineus Medical2023-05-19
I.V. Administration Set, I.V. Extension Set (K223645)Bq Plus Medical Co., Ltd.2023-05-18
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (K223437)Hartalega NGC Sdn. Bhd.2023-05-17
VERSAJET Hydrosurgery System (III) (K220964)Smith & Nephew Medical Limited2023-05-16
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (K230121)Careglove Global Sdn. Bhd.2023-05-15
BD Secondary Infusion Set (K223101)Care Fusion2023-05-12
Digital Thermometer (Model QT001) (K223044)Shen Zhen Rong Feng Technology Co., Ltd.2023-05-10
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (K223015)Plasmapp Co,., Ltd.2023-05-09
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use (K212857)Jiangsu Zhiyu Medical Instrument Co, Ltd.2023-05-09
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K223023)Plasmapp Co,., Ltd.2023-05-09
Tyvek Roll with CI for STERLINK Sterilizer (K223025)Plasmapp Co,., Ltd.2023-05-09
Disposible Nitrile Gloves (K223280)Holik Asia Group Co.,Ltd2023-05-08
Lexa MINI (RIS-303, RIS-305) (K223858)W&H Sterilization S.R.L.2023-05-05
Polyguard and Polyshield Safety IV Catheters (K230616)Poly Medicure Limited2023-05-05
Sol-Guard Auto-disable Syringe (K220713)Sol-Millennium Medical, Inc.2023-05-04
Orchid Safety Release Valve (K230266)Linear Health Sciences, LLC2023-05-04
RIA Safeguard (K222416)Ria Tech Co., Ltd.2023-05-01
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color (K221983)Guangdong Kingfa Sci. & Tech.Co., Ltd.2023-04-27
Omnipod GO Insulin Delivery Device (K223372)Insulet Corporation2023-04-24
Neodent Implant System - Helix Short Surgical Kit Cases (K223662)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2023-04-20
NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector (K220288)Np Medical, Inc.2023-04-19
EpiFinder (K221974)Omeq Medical , Ltd.2023-04-16
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K220345)Plasmapp Co,., Ltd.2023-04-14
OSPREY PERIPHERAL IV Catheter System (K223018)Skydance Vascular, Inc.2023-04-14
Polyfusion IV Administration Sets (K220312)Poly Medicure Limited2023-04-12
BD SmartSite™ Needle-Free Connector (K223088)Care Fusion2023-04-07
Disposable Insulin Pen Needle (K222739)Hantech Medical Device Co., Ltd.2023-04-06
Spectrum IQ Infusion System with Dose IQ Safety Software (K230041)Baxter Healthcare Corporation2023-03-31
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (K230022)Baxter Healthcare Corporation2023-03-31
SNOO Smart Sleeper (DEN210039)Happiest Baby, Inc.2023-03-30
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K220088)Professional Latex Sdn Bhd2023-03-30
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K230582)STERIS Corporation2023-03-28
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs (K220644)Yty Industry (Manjung) Sdn Bhd2023-03-25
Vinyl examination gloves (K230046)Guangdong Kingfa Sci. & Tech.Co., Ltd.2023-03-25
BD Texium™ Closed Male Luer (K223076)Care Fusion2023-03-24
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (K230002)Mah Sing Healthcare Sdn. Bhd.2023-03-24
Sterile Hypodermic Syringe for Single Use (K212207)Shandong Weigao Group Medical Polymer Co., Ltd.2023-03-23
Sterilization Wrap (K222151)Kenpax International Limited2023-03-23
Disposable Medical Nitrile Examination Gloves (K223895)Hebei Titans Hongsen Medical Technology Co., Ltd.2023-03-23
Instrument Case P1340904 (K223672)Cochlear2023-03-21
Shina Safety Needle (K222417)Shina Corporation2023-03-20
Nitrile Examination Gloves (K222813)Ecoglove Medical Manufacturing Company Limited2023-03-16
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. (K223375)Kossan International Sdn Bhd32023-03-15
Tegamen Nitrile Examination Gloves (K223102)M/S Tegamen Safety Products Private Limited2023-03-15
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