Atlas FDA

General Hospital

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

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RecordFirmDate
Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) (K192681)Jiangsu Kangbao Medical Equipment Co., Ltd.2020-07-28
StaClear Syringe (K200242)Tribofilm Research, Inc.2020-07-27
Disposable Temperature Probe (K193625)Shenzhen Changke Connect Electronics Co., Ltd.2020-07-24
Empty EVA Bag (K193528)Haemotronic S.P.A.2020-07-22
Benesta Medical Sterilization Tray (K193603)Caldera Medical, Inc.2020-07-20
Retractable Safety Insulin Syringe (K193022)Jiangsu Caina Medical Co.,Ltd2020-07-20
Intravascular Extension Sets and Accessories (K192366)Baxter Healthcare Corporation2020-07-20
Syringe with safety needle, Safety needle (K193526)Jiangsu Caina Medical Co.,Ltd2020-07-17
Infrared Thermometer Model Number RN-50A,RN-50B (K200578)Ningbo Ranor Medical Science & Technology Co., Ltd.2020-07-16
iHealth Infrared No-Touch Forehead Thermometer (K200531)Andon Health Co, Ltd.2020-07-15
BD SoloShot Mini Syringe/ BD Auto Disable Syringe (K201234)Becton, Dickinson and Company2020-07-15
Orbit Subretinal Delivery System (K200325)Orbit Biomedical2020-07-14
Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) (K200960)Medline Industires, Inc.2020-07-13
Allograft MIS Delivery System (K201338)Lifenet Health2020-07-13
Digital Thermometer (K200599)Joytech Healthcare Co. , Ltd.2020-07-08
ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable (K192385)Ivwatch, LLC2020-07-02
3M Attest Steam Chemical Integrator Test Pack (K200766)3M Company2020-07-02
Terragene Chemdye (K200272)Terragene S.A.2020-06-30
STATClave G4 Chamber Autoclave (K192910)Scican , Ltd.2020-06-19
Infrared Thermometer Model Number RN-60A,RN-60B (K200471)Ningbo Ranor Medical Science & Technology Co., Ltd.2020-06-19
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl (K192954)Comfort Rubber Gloves Industries Sdn. Bhd.2020-06-19
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for (K200671)Ansell Healthcare Products, LLC2020-06-19
Aerus Medical Guardian,model F170A (K201220)Aerus Medical, LLC2020-06-17
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (K193253)Shenzhen Changkun Technology Co., Ltd.2020-06-17
mCare(R) Powder Free Nitrile Orange Examination Gloves (K200967)Mercator Medical (Thailand), Ltd.2020-06-06
3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H (K192550)3M Company2020-06-05
Latex Examination Powder Free Glove, Aloe Vera (K193150)Top Glove Sdn. Bhd.2020-06-05
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (K193555)Ever Global (Vietnam) Enterprise Corp2020-06-04
3MTM AttestTM Rapid 5 Steam-Plus Test Pack (K200536)3M Complany2020-06-01
Aspire Mechanical Aspirator G (K200629)Control Medical Technology2020-05-29
VERIFY Assert Self-Contained Biological Indicator (K200126)STERIS Corporation2020-05-22
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (K190559)AngioDynamics, Inc.2020-05-22
Getinge Assured MI Steam Migrating Integrator (K200252)Steritec Products Mfg Co, Inc.2020-05-21
LifeFlow Blood System (K191362)410 Medical, Inc.2020-05-20
3D GraftRasp System (K200431)Surgentec2020-05-18
EZ-Inject Single use Needle (K192222)Poonglim Pharmatech, Inc.2020-05-12
Chemfort CSTD (K192866)Simplivia Healthcare , Ltd.2020-05-07
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC (K200453)Yty Industry (Manjung) Sdn Bhd2020-05-01
O-Genesis Graft Delivery System (K200606)Orthofix, Inc.2020-05-01
Turbett Instrument Pod (K200240)Turbett Surgical, Inc.2020-04-30
Biowy PICC Catheter S Kit (K192246)Biowy Corporation2020-04-30
Vicks VNT200 No Touch Forehead Thermometer (K193213)Kaz USA, Inc., A Helen of Troy Company2020-04-28
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K200581)Hartalega NGC Sdn. Bhd.2020-04-25
MF SAFECATH (K192230)Medifirst Co., Ltd.2020-04-23
Infrared Forehead Thermometer (K190984)Xiamen Ants Bro Technology Co., Ltd.2020-04-22
Droplet Pen Needle 34G (K192082)Htl-Strefa S.A2020-04-21
CapKlenZ (K192382)Star Mountain Medical, Inc.2020-04-20
Rio Vial-to-Bag Drug Reconstitution Device (K192154)Icu Medical2020-04-20
Molekule Air Pro RX (K200500)Molekule, Inc.2020-04-15
3MTM AttestTM Mini Auto-reader 490M (K200092)3M2020-04-15
Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch (K193561)Weihai Xingtai Packaging Products Co., Ltd.2020-04-15
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K200181)Comfort Rubber Gloves Industries Sdn. Bhd.2020-04-15
UroLift System Procedure Kit Sterilization Tray (K192781)Neotract, Inc.2020-04-14
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid (K200072)Kimberly-Clark Corporation2020-04-10
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use (K192679)Gemtier Medical (Shanghai), Inc.2020-04-10
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (K200539)Sri Trang Gloves (Thailand) Public Company Limited2020-04-09
Powder Free Nitrile Examination Glove (Aqua Green) (K200326)Riverstone Resources Sdn Bhd2020-04-09
TCAT TKA Instrument Tray Set (K200632)THINK Surgical, Inc.2020-04-08
BD Centro Vena Acute Central Line (7 French Dual Lumen) (K200266)Bard Access Systems, Inc. (Bard Has Joined Bd)2020-04-07
BlueStar Rx (K193654)Welldoc, Inc.2020-04-07
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) (K200019)Hartalega NGC Sdn. Bhd.2020-04-06
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable (K200319)Deroyal Industries, Inc.2020-04-02
QwikCheck Chemical Indicators (K192445)Serim Research Corporation2020-04-02
Introcan Safety 2 IV Catheter 18-24 gauge (K192676)B.Braun Medical, Inc.2020-04-01
JJ Series Container System (K192056)Aesculap, Inc.2020-03-27
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (K193121)Eco Medi Glove Sdn. Bhd.2020-03-20
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster (K193581)Sri Trang Gloves (Thailand) Public Company Limited2020-03-20
IV Sets not made with PVC (K191658)B.Braun Medical, Inc.2020-03-19
SterilContainer S2 System (K193582)Aesculap, Inc.2020-03-17
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) (K191753)Medline Industries, Inc.2020-03-17
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192241)O&M Haylard, Inc.2020-03-13
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K193110)3M Healthcare2020-03-13
Health Line CT Midline Catheter (K200263)Health Line International Corporation2020-03-12
SpaceStation MRI (K191910)B. Braun Melsugen AG2020-03-12
SwabTip Male Disinfectant Cap (K190918)Icu Medical2020-03-06
Avinent Surgical Tray (K191566)Avinent Implant System S.L.U.2020-03-06
Omnifix Low Dead Space Luer Lock Syringe (K193101)B.Braun Medical, Inc.2020-03-05
Unity Subcutaneous Infusion System for Remodulin (K191313)DEKA Research & Development2020-02-21
Flowart (K190806)Asset Medikal Tasarim As.2020-02-20
HydroPICC (PICC-142) (K193015)Access Vascular, Inc.2020-02-20
Mixing and Delivery System (K192674)Bone Solutions, Inc.2020-02-18
Microlife Non-Contact Infrared Forehead Thermometer (K191829)Microlife Intellectual Property GmbH2020-02-13
Praxiject 0.9% NaCl (K192414)Medxl, Inc.2020-02-13
EleGARD Patient Positioning System (K191689)Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio2020-02-13
3M Attest Super Rapid 5 Steam-Plus Challenge Pack (K193154)3M Company2020-02-07
OptiScanner® 5000 Glucose Monitoring System (K192785)Optiscan Biomedical Corporation2020-02-05
Bella-mu (K190962)U-Needle B.V.2020-02-03
Tamper Evident Cap (K193192)International Medical Industries, Inc.2020-01-31
Gemini Titan Sterilization Wrap (K192641)Medline Industries, Inc.2020-01-24
Blue Nitrile Examination Gloves Powder Free (K192333)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2020-01-24
BD Cathena (TM) Safety IV Catheter (K192493)Becton Dickinson Infusion Therapy Systems, Inc.2020-01-24
STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader (K192025)Advanced Sterilization Products (Asp)2020-01-23
Bactisure Wound Lavage (K192349)Next Science, LLC2020-01-23
Hydro-Temp Neonatal Skin Temperature Probe Cover (K191425)Deroyal Industries, Inc.2020-01-21
Medline Glide-On 3G Vinyl Examination Gloves (K192985)Medline Industries, Inc.2020-01-21
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) (K192635)Wrp Asia Pacific Sdn. Bhd.2020-01-17
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) (K192315)Medline Industries, Inc.2020-01-10
Disposable Powder Free Nitrile Examination Glove, Pink/Black Color (K190942)Ever Growth (Vietnam) Co. , Ltd.2020-01-07
TK Sterile Piston Syringe without Needle (K191642)Anhui Tiankang Medical Technology Co., Ltd.2020-01-06
PiccGuard (K191195)Piccguard, LLC2020-01-03
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