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Data / Medical devices / United States / Atlas Medical Products LLC

Atlas Medical Products LLC: FDA-registered device maker in Hialeah, FL, United States, 14 510(k) clearances

Atlas Medical Products LLC is registered with the FDA (registration 3010621964) in Hialeah, FL, United States. It lists 58 device types. The FDA files 14 510(k) clearances under its listings, the newest dated April 12, 2022. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Atlas Medical Products LLC
FDA registration number
3010621964
Address
4401 E 10th Ave, Hialeah, FL, United States, 33013
Owner or operator
Atlas Medical Products LLC (10045445)
Roles
Repackager or relabeler
First device listed
March 9, 2021
Registered through
2026
Brand names listed
ROSPITAL, ROSPITAL BLOOD COLLECTION NEEDLER HOLDER, ROSPITAL BLOOD COLLECTION SETS, ALL SIZES AND BLOOD COLLECTION SET ALL SIZES WITH HOLDER, ROSPITAL CLOSED WOUND DRAINAGE SYSTEM 10 FR AND 19 FR, ROSPITAL ENDOTRACHEAL TUBE, ROSPITAL ESU PENCIL, ROSPITAL ESU PLATE, ROSPITAL FOLEY CATHETER and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Repackager or relabeleraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Repackager or relabeleraccessdata.fda.gov
Appliance, Colostomy, DisposableEZS1Repackager or relabeleraccessdata.fda.gov
Bag, Drainage, With Adhesive, OstomyFON1Repackager or relabeleraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Repackager or relabeleraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Repackager or relabeleraccessdata.fda.gov
Bandage, CastITG1Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Repackager or relabeleraccessdata.fda.gov
Cap, SurgicalFYF1Repackager or relabeleraccessdata.fda.gov
Catheter, Balloon TypeGBA1Repackager or relabeleraccessdata.fda.gov
Catheter, InfusionJCY1Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Repackager or relabeleraccessdata.fda.gov
Catheter, IrrigationGBX1Repackager or relabeleraccessdata.fda.gov
Catheter, Nasal, OxygenBZB1Repackager or relabeleraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Repackager or relabeleraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Repackager or relabeleraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Repackager or relabeleraccessdata.fda.gov
Container, SharpsMMK2Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Repackager or relabeleraccessdata.fda.gov
Container, Specimen, SterileFMH1Repackager or relabeleraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Repackager or relabeleraccessdata.fda.gov
Dress, SurgicalFYE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Repackager or relabeleraccessdata.fda.gov
Gown, ExaminationFME1Repackager or relabeleraccessdata.fda.gov
Gown, SurgicalFYA2Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)KFZ1Repackager or relabeleraccessdata.fda.gov
Mask, OxygenBYG1Repackager or relabeleraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Repackager or relabeleraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Repackager or relabeleraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Pouch, ColostomyEZQ1Repackager or relabeleraccessdata.fda.gov
Scalpel, One-PieceGDX1Repackager or relabeleraccessdata.fda.gov
Set, Administration, IntravascularFPA2Repackager or relabeleraccessdata.fda.gov
Shoe And Shoe Cover, ConductiveBWP1Repackager or relabeleraccessdata.fda.gov
Solvent, Adhesive TapeKOX1Repackager or relabeleraccessdata.fda.gov
Speculum, Non-IlluminatedFXE1Repackager or relabeleraccessdata.fda.gov
Support, Breathing TubeJAY1Repackager or relabeleraccessdata.fda.gov
Syringe, AntistickMEG2Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Repackager or relabeleraccessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, ManualKST1Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Tape, Camera, SurgicalFXN1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager or relabeleraccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Repackager or relabeleraccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 12, 2022K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)FMISubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
October 18, 2021K211555Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeMEGSubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
February 19, 2021K202188Safety Blood Collection Sets for Single UseJKASubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
July 28, 2020K192681Safety 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)FPASubstantially EquivalentJiangsu Kangbao Medical Equipment Co., Ltd.accessdata.fda.gov
January 6, 2020K191642TK Sterile Piston Syringe without NeedleFMFSubstantially EquivalentAnhui Tiankang Medical Technology Co., Ltd.accessdata.fda.gov
September 6, 2019K190213Yikang Endotracheal TubeBTRSubstantially EquivalentJiangxi Yikang Medical Instrument Group Co., Ltd.accessdata.fda.gov
September 6, 2019K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single UseMEGSubstantially EquivalentJiangsu Micsafe Medical Technology Co., Ltd.accessdata.fda.gov
January 16, 2019K173847Disposable Ultra Reinforced Surgical GownFYASubstantially EquivalentXiantao Rayxin Medical Products Co., Ltd.accessdata.fda.gov
January 3, 2019K180984Maxcon Sharps ContainerMMKSubstantially EquivalentNingbo Maxcon Medical Technology Co., Ltd.accessdata.fda.gov
July 19, 2018K170369Disposable Electrosurgical PencilsGEISubstantially EquivalentCathay Manfacturing Corp.accessdata.fda.gov
July 13, 2018K173340Yikang Latex Foley CatheterEZLSubstantially EquivalentJiangxi Yikang Medical Instrument Group Co., Ltd.accessdata.fda.gov
March 22, 2017K163017Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy DrugsLZCSubstantially EquivalentGmp Medicare Sdn. Bhd.accessdata.fda.gov
June 18, 2015K142797I.V. CatheterFOZSubstantially EquivalentJiangxi Sanxin Medtec Co., Ltd.accessdata.fda.gov
August 22, 2013K130027DISPOSABLE NEUTRAL ELECTRODE GP202GEISubstantially EquivalentCathay Manufacturing Corp.accessdata.fda.gov

Compare with other makers

Updated April 12, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.