Atlas FDA

General Hospital

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

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RecordFirmDate
AMSafe(R) Pre-Filled Normal Saline Flush Syringe (K183473)Amsino International, Inc.2019-07-12
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted (K181957)Tianchang Jiarui Packaging Material Co., Ltd.2019-07-09
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F (K180994)Interrad Medical, Inc.2019-07-09
Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves (K181456)Tuttnauer , Ltd.2019-07-08
Bard Power-Injectable Implantable Ports (PowerPorts®) (K181446)C.R. Bard, Inc.2019-07-08
Aesculap® SterilContainer(TM) S2 System (K182414)Aesculap, Inc.2019-07-05
Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim (K183149)Central Medicare Sdn Bhd2019-07-04
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) (K190080)Comfort Rubber Gloves Industries Sdn. Bhd.2019-06-27
Rochal Bioshield Silicone Film (K182733)Rochal Industries, LLC2019-06-27
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K182851)O&M Halyard, Inc.2019-06-26
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate (K183354)Gx Corporation Sdn Bhd2019-06-20
Powder-Free Clear Vinyl Patient Examination Gloves (K190095)Anhui Intco Medical Products Co., Ltd.2019-06-20
Med-link Temperature Probes (K182667)Shenzhen Med-Link Electronics Tech Co., Ltd.2019-06-18
Medline Digital Rectal Thermometer Sheath (K183431)Medline Industries, Inc.2019-06-14
Sonopet iQ Sterilization Tray (K190667)Paragon Medical2019-06-13
JAMBRO Single Core A Sterilization wrap (K182656)Jiangsu Zhande Medical Supplies Co., Ltd.2019-06-11
Ivenix Infusion System (IIS) (K183311)Ivenix, Inc.2019-06-07
Tiger Sharps Containers (K190240)International Marketing Specialists, Inc.2019-05-31
Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs (K182308)Sri Trang Gloves (Thailand) Co., Ltd.2019-05-30
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (K190606)Kossan International Sdn Bhd2019-05-28
Clearlink System Solution Set (K180739)Baxter Healthcare Corporation2019-05-28
Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K182575)Jiangxi Jaysun Medcare Co., Ltd.2019-05-24
OnSite Waste Sharps Container (K182235)Bluestone Medical, Inc.2019-05-20
Cook Unimpregnated Central Venous Catheter (K182252)Cook Incorporated2019-05-17
Celerity HP Incubator (K190297)STERIS Corporation2019-05-14
Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) (K182612)Zibo Yahao Supplies Co., Ltd.2019-05-10
V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems (K190917)STERIS Corporation2019-05-09
DePuy Synthes Sterilization Container System (K181933)Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2019-05-09
Stryker ChestShield Sterilization Tray System (K183701)Paragon Medical2019-05-07
Neodent Instruments Kits (K182865)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2019-05-07
SteriCap Mini Needle (K183016)Ocujet, LLC2019-05-07
Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove (K190159)Showa Best Glove, Inc.2019-05-06
Unity Subcutaneous Delivery System for Remodulin (K190182)DEKA Research & Development2019-05-06
Wireless Intelligent Thermometer (K182437)Shenzhen Jumper Medical Equipment Co., Ltd.2019-05-05
K-Shield Advantage Port Access Infusion Set (PAIS) (K190233)Kawasumi Laboratories, Inc.2019-05-02
Additive Cap (K190305)International Medical Industries, Inc.2019-04-30
BD Intelliport System (K182092)Becton, Dickinson and Company2019-04-30
Elcam Stopcocks and Manifolds (K190489)Elcam Medical Acal2019-04-23
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) (K182640)Shandong Hengya Packaging Printing Co.,Ltd2019-04-12
Oryum and Ovem Epidermal Deri Prick Test Applicator (K182582)Allergy & Applicator Depot, LLC2019-04-10
Adult Intraosseous Infusion Device (K182770)Einstein Works, LLC2019-04-09
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K183287)Kossan International Sdn Bhd2019-04-05
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System (K190103)STERIS Corporation2019-04-05
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) (K182268)Flat Medical Co., Ltd.2019-04-05
HIgH-Flo Super26 Subcutaneous Needle Sets (K180843)Repro-Med Systems, Inc. Dba Rms Medical Products2019-04-04
Infrared thermometer (K182597)Shenzhen Pango Electronic Co., Ltd.2019-04-03
AMSCO 600 Steam Sterilizer (K183410)STERIS Corporation2019-03-27
Tyto Thermometer (K190242)Tyto Care , Ltd.2019-03-27
Velano Vascular Q2 Extension Set (K182897)Velano Vascular2019-03-26
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs (K182554)He Chuang Plastic & Rubber Co., Ltd.2019-03-22
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System (K190104)Steris Corporations2019-03-22
ON-Q* Pump with Bolus (K181360)Halyard Health2019-03-22
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) (K181959)Owens & Minor Halyard, Inc.2019-03-22
BD Nexiva Closed IV Catheter System (K183399)Becton Dickinson Infusion Therapy Systems, Inc.2019-03-20
Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue (K182383)Yty Industry (Manjung) Sdn Bhd2019-03-19
nextaro Transfer System, nextaro va (K183187)Sfm Medical Devices GmbH2019-03-15
TCAT (R) THA Instrument Tray Set (K180127)THINK Surgical, Inc.2019-03-15
ClearMate (DEN170044)Thornhill Research, Inc.2019-03-14
BD Plastipak Syringe (K182589)Becton, Dickinson and Company2019-03-14
Safety insulin needle for single use (K181447)Berpu Medical Technology Co., Ltd.2019-03-12
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs (K182241)Sri Trang Gloves (Thailand) Co., Ltd.2019-03-11
Introcan Safety 3 Closed IV Catheter (K182870)B.Braun Medical, Inc.2019-03-07
MAC Medical D-Series Blanket and Solution Warming Cabinets (K180842)Mac Medical, Inc.2019-03-05
Lead-free Chemical Indicators for Steam Sterilization (K181788)Kem Medical Products Corp.2019-03-01
BD Vacutainer Eclipse UltraFill Blood Collection Needle (K181730)Becton, Dickinson and Company2019-03-01
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K183401)STERIS Corporation2019-03-01
PRO-LITE Sterilization Tray (K183402)STERIS Corporation2019-03-01
Digital Thermometer (K182629)Joytech Healthcare Co. , Ltd.2019-02-28
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use (K181870)Wuhan W.E.O Science & Technology Development Co., Ltd.2019-02-26
Omni Instrument Tray (K182052)Hologic, Inc.2019-02-26
3M Comply Hydrogen Peroxide Chemical Indicator (K183211)3M Company2019-02-26
Babyleo TN500 (K182859)Dragerwerk AG & CO Kgaa2019-02-22
3M Comply Hydrogen Peroxide Indicator Tape (K183209)3M Company2019-02-15
Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP (K181393)Valmed S.R.L.2019-02-15
U&U Blood Collection Sets (K181508)U&U Medical Technology Co, Ltd.2019-02-13
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K183132)O&M Halyard, Inc.2019-02-05
Endoscope Sterilization Tray (K183139)Intuitive Surgical, Inc.2019-02-01
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (K182827)STERIS Corporation2019-01-31
Quantum Blood and IV Fluid Infusion Warmer (K181775)Life Warmer, Inc.2019-01-28
Greenmedi Safety Filter Syringe (K173743)Sang-A Frontec Co., Ltd.2019-01-28
FEMON Banana Thermometer (K180767)Life Science Technology, Inc.2019-01-22
Powder Free Nitrile Patient Examination Gloves, Blue Color (K181106)Jiangsu Dongxin Medical Technology Co., Ltd.2019-01-16
Merit RadialFlo Arterial Catheter (K182538)Merit Medical Singapore Pte. , Ltd.2019-01-16
Tamper Evident Cap with Male Luer Lock (K182545)International Medical Industries, Inc.2019-01-11
Infrared Ear Thermometer (K180387)Hetaida Technology Co., Ltd.2019-01-10
Advocate Non-Contact Infrared Thermometer (K180355)Broadmaster Biotech, Corp.2019-01-10
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K182630)Insulet Corporation2019-01-08
VERIFY VH202 Indicator Tape (K183293)STERIS Corporation2019-01-04
Celerity HP Chemical Indicator (CI) (K183295)Steris Corporations2019-01-04
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (K182568)STERIS Corporation2019-01-03
PRO-LITE Sterilization Tray (K183301)STERIS Corporation2019-01-03
Safe Secure Sterilization Pouches and Rolls (K180139)Safe Secure Packing Co., Ltd.2019-01-03
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack (K183294)STERIS Corporation2019-01-03
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K183297)STERIS Corporation2019-01-03
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (K183300)Steris Corporations2019-01-03
Maxcon Sharps Container (K180984)Ningbo Maxcon Medical Technology Co., Ltd.2019-01-03
Maxcon Two Gallon Chemotherapy Container (K180983)Ningbo Maxcon Medical Technology Co., Ltd.2019-01-03
Infrared Thermometer (K181215)Shenzhen Finicare Co., Ltd.2019-01-02
STERRAD VELOCITY Biological Indicator (K182404)Advanced Sterilization Products (Asp)2018-12-27
Disposable Temperature Probe (K182755)Shenzhen Caremed Medical Technology Co., Ltd.2018-12-21
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