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General Hospital

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

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RecordFirmDate
EleGARD (K221901)Advancedcpr Solutions, LLC2022-07-29
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) (K221271)Shandong Maida Medical Technology Co., Ltd.2022-07-27
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K221269)Better Care Plastic Technology Co., Ltd.2022-07-27
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap (K214007)Owens & Minor (O&M) Halyard, Inc.2022-07-27
Powder-Free Nitrile Examination Glove, Non-Sterile (K221877)Goodgloves Industries Sdn Bhd2022-07-23
Celerity Incubator (K213881)STERIS Corporation2022-07-21
Syringe with permanently attached needle (K213158)Berpu Medical Technology Co., Ltd.2022-07-21
Pump Alignment Syringe (K220184)Jiangsu Caina Medical Co.,Ltd2022-07-21
Pentaflush (K214080)Pentaferte Italia S.R.L.2022-07-20
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim (K220943)Eco Medi Glove Sdn. Bhd.2022-07-19
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves (K221229)Zibo Blue Sail Health Technology Co., Ltd.2022-07-16
0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub (K213955)Becton, Dickinson and Company2022-07-16
NxtGen Infant Transport Incubator (K220742)International Biomedical2022-07-15
Examination gloves-Type A(Latex gloves) (K214017)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022-07-14
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle (K220204)Anhui Tiankang Medical Technology Co., Ltd.2022-07-14
Disposable Medical Nitrile Examination Gloves - Non Sterile (K221454)Guangzhou Kangling Biotechnology Co., Ltd.2022-07-12
Nitrile Medical Examination Gloves (K221108)Anhui Fulewei Electronic Technology Co.,Ltd2022-07-12
Nitrile Vinyl Blend Powder Free Examination Gloves (Black) (K213574)Grand Work Plastic Products Co., Ltd.2022-07-12
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves (K220825)American Nitrile Operations, LLC2022-07-08
Powder Free Nitrile Examination Gloves (Blue) (K220284)Kgm Gloves Sdn. Bhd.2022-07-08
Insulin Pen Needle (K221176)Tianjin Huahong Technology Co., Ltd.2022-07-01
CerroZone Mobile (K220298)Cerrozone2022-07-01
Powder Free Nitrile Examination Glove (K220834)Daxwell, LLC2022-06-29
3M Attest Rapid Readout Biological Indicator, 1295 (K211705)3M Company2022-06-28
BD Pen Needle (K213478)Becton, Dickinson and Company2022-06-28
3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) (K220942)3M Company2022-06-24
BentrioTM Allergy Blocker (K213114)Altamira Therapeutics, Inc.2022-06-24
Introcan Safety 2 IV Catheter (K220756)B.Braun Medical, Inc.2022-06-23
TC Gloves (K221185)Thanh Cong Pharmaceutical and Trading Company Limited2022-06-22
Qlicksmart BladeFlask UNIVERSAL (K213274)Qlicksmart Pty , Ltd.2022-06-22
Disposable Nitrile Powder-Free Examination Gloves (K221192)Shandong Maida Medical Technology Co., Ltd.2022-06-22
Nitrile Examination Gloves (K213739)Hangzhou Runheng Medical Co., Ltd.2022-06-22
Vial Adapter Ø13mm (K220856)Avenir Performance Européenne Medical (Apem)2022-06-21
Zuno Smart Sterilization Container (DEN210004)Zuno Medical, Inc.2022-06-17
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile (K220431)One Glove Industrial Sdn Bhd2022-06-17
TC Gloves (K221186)Thanh Cong Pharmaceutical and Trading Company Limited2022-06-16
1st Glove Blue Nitrile Examination Gloves Powder Free (K221226)Koove Iot Pvt. , Ltd.2022-06-16
Disposable Vinyl Examination Glove (K220469)Chifeng Huawei Medical Science&Technology Co., Ltd.2022-06-16
MEDOJECT fine Pen Needles (K220614)Chirana T. Injecta2022-06-15
TrabEx Pro (K213173)Microsurgical Technologies, Inc.2022-06-08
Zoupure Nitrile Powder Free Examination glove (K220693)Thai Rayong Product Glove Zoupure Co., Ltd.2022-06-07
Powder Free Nitrile Gloves (K213448)St Future International Limited2022-06-06
Q2 Blood Administration Sets (K213846)Quest Medical, Inc.2022-06-05
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim (K220672)Riverstone Resources Sdn Bhd2022-06-03
Q2 IV Administration Sets (K213588)Quest Medical, Inc.2022-06-02
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves (K220547)O&M Halyard, Inc.2022-06-02
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves (K220541)O&M Halyard, Inc.2022-06-02
freeflex+ Transfer Adapter (K212445)Fresenius Kabi AG2022-06-01
Purgo (K213753)Aeroclean Technologies, LLC2022-06-01
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) (K220488)Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.2022-06-01
IRRIGO Wound Wash Jet System (K210987)Inopro, Inc.2022-05-31
Disposable Powder Free Polyethylene Examination Gloves (K212699)Mastermax Plastic (Huizhou), Ltd.2022-05-31
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution (K213141)Shen Wei USA, Inc.2022-05-28
Blue Nitrile Examination Gloves Powder Free (K212584)Amazing Rubber Products Pvt, Ltd.2022-05-28
Amazing+ Latex Examination Powder Free Gloves (K212597)Amazing Rubber Products Pvt, Ltd.2022-05-28
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) (K220609)Encompass Industries Sdn. Bhd.2022-05-27
Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs (K220545)Hl Rubber Industries Sdn Bhd2022-05-26
PP Care Nitrile Examination Gloves (K212629)Eg Group Product and Services Co., Ltd.2022-05-26
Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) (K220249)Grand Work Plastic Products Co., Ltd.2022-05-26
Aura Storm (K212644)Invictus Lighting2022-05-26
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E (K213485)Shenzhen AOJ Medical Technology Co., Ltd.2022-05-25
LDV((Low Dead Volume )Syringe (K220083)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-05-25
Well-life TM Pen Needles, Well-life TM Safety Pen Needles (K210748)W. L. Med Co., Ltd.2022-05-25
S-Line (K213191)Barkey GmbH & Co. KG2022-05-24
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs (K220155)Motex Healthcare (Anhui) Co., Ltd.2022-05-23
3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large (K220507)3M Company2022-05-23
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 (K220564)3M Company2022-05-23
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) (K211810)Pt. Shamrock Manufacturing Corpora2022-05-23
Artiglass NRFitTM Tip L.O.R. Glass Syringes (K213800)Artiglass Srl2022-05-19
Nitrile Powder Free Examination Gloves (K220211)Hebei Kangxida Medical Technology Development Co., Ltd.2022-05-18
GSS610N21 Series Steam Sterilizer (K214120)Maquet GmbH2022-05-18
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) (K212408)Pt. Maja Agung Latexindo2022-05-18
Clicky Cross (K210516)Yomura Technologies, Inc.2022-05-16
STERRAD NX with ALLClear Technology (K220404)Advanced Sterilization Products, Inc.2022-05-16
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs (K220491)Hainan Asther Medical Equipment Co., Ltd.2022-05-14
Introcan Safety IV Catheter (K220626)B.Braun Medical, Inc.2022-05-14
Provena(TM) Midline Catheter (K213203)C.R. Bard, Inc.2022-05-13
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile (K220429)One Glove Industrial Sdn Bhd2022-05-13
Sterile Safety Hypodermic Needles for Single Use (K213535)Zhejiang Kangkang Medical-Devices Co., Ltd.2022-05-13
Sterile Hypodermic Syringes for Single Use (K213811)Berpu Medical Technology Co., Ltd.2022-05-12
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves (K220118)Kl-Kepong Rubber Products Sdn. Bhd.2022-05-12
Synguard Nitrile Exam Glove (K220442)Tianjin Aoshang Outdoor Equipment Co., Ltd.2022-05-12
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 (K210937)Alicn Medical Shenzhen, Inc.2022-05-12
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (K220250)Grand Work Plastic Products Co., Ltd.2022-05-11
Needle Free Connector (K213004)Medcaptain Life Science Co., Ltd.2022-05-10
White Nitrile Powder-Free Patient Examination Glove, Non Sterile (K220427)One Glove Industrial Sdn Bhd2022-05-10
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile (K220428)One Glove Industrial Sdn Bhd2022-05-10
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 (K210565)Alicn Medical Shenzhen, Inc.2022-05-05
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 (K212346)Shenzhen Pango Medical Electronics Co., Ltd.2022-05-05
Steriking Packaging for Medical Devices (K221016)Wipak OY2022-05-05
HydroPICC 5F Dual Lumen Catheter (K213550)Access Vascular, Inc.2022-05-04
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 (K212257)Alicn Medical Shenzhen, Inc.2022-05-04
Surgical and Prosthetic Trays (K220791)Dentsply Sirona2022-05-03
Orchid Safety Release Valve(TM) (K212064)Linear Health Sciences, LLC2022-05-03
SteriTite Container System with MediTray Products (K212711)Case Medical, Inc.2022-04-29
Elite Biomedical Solutions Dose Request Cord (K220695)Elite Biomedical Solutions2022-04-29
Safety Pen Needle for Single Use, Insulin Pen Needles (K212514)Berpu Medical Technology Co., Ltd.2022-04-29
FreedomEdge Syringe Infusion System (K214045)Repro-Medical System, Inc., Dba Koru Medical Systems2022-04-29
Spectrum IQ Infusion System with Dose IQ Safety Software (K220417)Baxter Healthcare Corporation2022-04-29
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 (K213040)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-04-27
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