Atlas FDA

General Hospital

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

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RecordFirmDate
SterilContainer S System (K182032)Aesculap, Inc.2018-12-21
Nitrile Glove Powder Free White (K183068)Haining Medical Products Co., Ltd.2018-12-21
BD Contoured Base Pen Needle (K182320)Becton, Dickinson and Company2018-12-20
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (K182387)Novo Nordisk, Inc.2018-12-17
SCIg60 Infusion System (K173783)Emed Technologies Corporation2018-12-14
NRFit Syringe (K181374)Jiangsu Caina Medical Co.,Ltd2018-12-14
neoBLUE blanket LED Phototherapy System (K182178)Natus Medical Incorporated2018-12-13
Cardinal Health Sterilization Wrap (K181174)Cardinal Health200, LLC2018-12-11
CelerityTM 10 STEAM Chemical Indicator (K182724)STERIS Corporation2018-12-10
Disposable Temperature Probe (K181967)Shenzhen Launch Electrical Co., Ltd.2018-12-10
RII Smart IR Thermometer (K163601)Radiant Innovation, Inc.2018-12-06
No-contact Forehead Thermometer (K173048)Dongguan Simzo Electronic Technology Co., Ltd.2018-12-06
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set (K182146)Sol-Millennium Medical, Inc.2018-12-03
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K182600)Better Care Plastic Technology Co., Ltd.2018-11-30
BD PhaSeal Optima Closed System Transfer Device (K181221)Becton, Dickinson and Company2018-11-30
welloStationX (K180298)Wello, Inc.2018-11-30
Non-contact Infrared Thermometer (K180207)Alicn Medical (Shenzhen), Inc.2018-11-28
Isolette 8000 Plus (K182977)Draeger Medical Systems, Inc.2018-11-21
Jet Power Injectable PICC (K180546)Jet Medical, Inc.2018-11-21
COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 (K182652)Kangfu Medical Equipment Factory2018-11-20
Orbit Subretinal Delivery System (K182274)Orbit Biomedical, Inc.2018-11-20
Infrared Thermometer (K182133)Shenzhen AOJ Medical Technology Co., Ltd.2018-11-20
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (K182931)Steris Corporations2018-11-20
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K181857)Kossan International Sdn Bhd2018-11-20
InstruSafe(R) Sterilization Container (K180528)Summit Medical, Inc.2018-11-16
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) (K180645)Hartalega Sdn Bhd2018-11-16
Nitrile Glove Powder Free Black (K182528)Haining Medical Products Co., Ltd.2018-11-15
SporView Rapid Read Biological Indicator SteamPlus Test Pack (K181434)Crosstex/Spsmedical, A Division of Cantel Medical2018-11-14
Immucise Intradermal Injection System (K181369)Terumo Corporation2018-11-13
EZ-IO Intraosseous Vascular Access System (K180395)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2018-11-09
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (K180047)Fiab Spa2018-11-08
Powder Free Vinyl Patient Examination Gloves (K180381)Shanxi Hongjin Plastic Technology Co., Ltd.2018-11-07
Certa Dose Pediatric Midazolam 5mg/mL IM Syringe (K180683)Certa Dose, Inc.2018-11-07
Merit Syringe (K182216)Merit Medical Systems, Inc.2018-11-06
Merit Syringe (K182279)Merit Medical Systems, Inc.2018-11-06
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff (K180786)Hartalega Sdn Bhd2018-11-02
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs (K182096)Owens & Minor Halyard, Inc.2018-11-02
Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter (K181208)Vygon USA2018-11-02
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer (K181239)Joytech Healthcare Co. , Ltd.2018-10-29
Swaive Thermometer SWT1A (K170723)E-Care Technology Co., Ltd.2018-10-25
BD Single Use, Hypodermic Syringe (K172670)Becton, Dickinson and Company2018-10-23
TD-1035 Thermometer (K172733)Taidoc Technology Corporation2018-10-22
BD FlowSmart Set/MiniMed Pro-Set (K181718)Becton, Dickinson and Company2018-10-18
Uroject12 Syringe Lever (K180345)Urogen Pharma, Ltd.2018-10-17
SBG Blue Nitrile Powder Free Medical Examination Glove (K180467)Showa Best Glove, Inc.2018-10-10
Temperature Probe (K173194)Orantech, Inc.2018-10-10
SBG Black Nitrile Powder Free Medical Examination Glove (K180468)Showa Best Glove, Inc.2018-10-10
Vinyl Patient Examination Gloves (K182117)Jiangxi Zhonghong Pulin Medical Products Co., Ltd.2018-10-06
Vinyl Patient Examination Gloves (K182115)Pingan Medical Products Co., Ltd.2018-10-03
Infrared Ear Thermometer (K181081)Joytech Healthcare Co. , Ltd.2018-10-02
KLOCKNER SURGICAL BOX (K173642)SOADCO, S.L.2018-10-02
Endoscope Sterilization Tray (K180964)Intuitive Surgical, Inc.2018-09-28
PureSet Tray (K181075)Nobel Biocare AB2018-09-27
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims (K181066)Eco Medi Glove Sdn. Bhd.2018-09-26
5 FR Dual Lumen Piper PICC (K181904)Piper Access, LLC2018-09-25
Probe Covers for Thermometers (K180714)K-Jump Health Co., Ltd.2018-09-24
TEVADAPTOR Closed Drug Reconstitution and Transfer System (K180489)Teva Medical Ltd., Migada Plant2018-09-21
Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) (K182043)Hebei Titans Hongsen Medical Technology Co., Ltd.2018-09-21
AMSafe Sure-Lok Needle-Free Connector (K173665)Amsino International, Inc.2018-09-05
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System (K173477)Icu Medical, Inc.2018-08-31
Disposable Insulin Pen Needle (K181069)Zhejiang Kindly Medical Devices Co., Ltd.2018-08-28
Fever Scout (K181013)VivaLNK, Inc.2018-08-21
BD Vacutainer Eclipse Signal Blood Collection Needle (K170824)Becton, Dickinson and Company2018-08-20
NuBorne Infant Warmer (K173516)International Biomedical2018-08-17
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor (K180574)J & J Solutions, Inc. D/B/A/ Corvida Medical2018-08-17
Biodegradable Nitrile Powder Free Examination Glove (Blue) (K173509)Hartalega Sdn Bhd2018-08-17
Vicks RapidRead Digital Thermometer (K180131)Kaz USA, Inc., A Helen of Troy Company2018-08-14
Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (K181130)Hebei Titans Hongsen Medical Technology Co., Ltd.2018-08-10
Diana Medication Transfer Set (K170110)Icu Medical, Inc.2018-08-10
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green (K180644)Hartalega Sdn Bhd2018-08-10
Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use (K180417)Berpu Medical Technology Co., Ltd.2018-08-09
Ageless Health Medical Digital Thermometer (K172508)Ageless Health Industrial Co., Ltd.2018-08-08
EasyTouch Safety Pen Needle (K163578)Mhc Medical Products, LLC2018-08-03
BH Sterilization Pouch (K172280)Bh Medical Products Co., Ltd.2018-08-03
Lockbox for Perfusor Space PCA Infusion Pump (K173531)B.Braun Medical, Inc.2018-08-02
Saniclave 250 (K180272)Revolutionary Science2018-07-26
CELERITY 20 Steam Biological Indicator (K181686)STERIS Corporation2018-07-24
Autokeeper (K172095)Medexel Co.,Ltd2018-07-24
Non-contact infrared body thermometer (K171888)Hetaida Technology Co., Ltd.2018-07-23
Braun BNT400 No Touch + Forehead Thermometer (K181242)Kaz USA, Inc., A Helen of Troy Company2018-07-23
Power Infuser (K172653)ZOLL Medical Corporation2018-07-18
Braun BFH175 Infrared Forehead Thermometer (K181015)Kaz USA, Inc., A Helen of Troy Company2018-07-18
Sonicision Reusable Sterilization Tray (K180915)Covidien2018-07-17
Infrared Thermometer (K172874)Shenzhen Jiacom Technology CO ., Ltd.2018-07-12
Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G (K173881)Owen Mumford, Ltd.2018-07-11
Infrared Thermometer (K180314)Xuzhou Yongkang Electronic Science Technology Co., Ltd.2018-07-11
PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs (K173766)Shen Wei USA, Inc.2018-07-08
Nitrile Patient Examination Powder Free Glove, Textured, Black (K161085)Multisafe Sdn. Bhd.2018-07-05
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel (K180720)Medibio USA, LLC2018-06-27
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K180646)Halyard Health2018-06-27
SecurAcath (K180769)Interrad Medical, Inc.2018-06-26
IV Administration Set (K173361)B.Braun Medical, Inc.2018-06-26
0.9% Sodium Chloride Injection, USP (K173348)Medline Industries, Inc.2018-06-21
Straumann BLX Surgical Cassette (K180791)Institut Straumann AG2018-06-21
Kopac Sterile Needle (K172483)Poonglim Pharmatech, Inc.2018-06-21
Sherlock 3CG+ T ip Confirmation System (K180560)C.R. Bard, Inc.2018-06-18
Disposable Sterile Needle (K172938)Jiangsu Caina Medical Co.,Ltd2018-06-14
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) (K180505)Hartalega Sdn Bhd2018-06-14
CELERITY 20 HP Biological Indicator (K181429)STERIS Corporation2018-06-13
VERIFY Assert Self-Contained Biological Indicator (K181442)STERIS Corporation2018-06-13
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