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Data / Medical devices / Dominican Republic / Microtek Dominicana, S.A.S.

Microtek Dominicana, S.A.S.: FDA-registered device maker in La Romana, Dominican Republic, 9 510(k) clearances

Microtek Dominicana, S.A.S. is registered with the FDA (registration 8043817) in La Romana, Dominican Republic. It lists 31 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 18, 2022. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Microtek Dominicana, S.A.S.
FDA registration number
8043817
FEI number
3003094575
Address
Zona Franca Ii, La Romana, Dominican Republic, 22000
Owner or operator
Medline Industries, LP (1417592)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
December 30, 1991
Registered through
2027
Brand names listed
"Salt Airway S.A.L.T.", 171415-O.R. KIT CSTM, ACCU-SORB, AKTORmed, ANKLE, Accessory to Hospira Device, Accu-Wrap, Aquablation Therapy and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufactureraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Repackager or relabeleraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Contract manufactureraccessdata.fda.gov
Apparatus, AutotransfusionCAC2Contract manufactureraccessdata.fda.gov
Bag, Bile CollectingEXF2Contract manufactureraccessdata.fda.gov
Bag, IntestineKGY1Contract manufacturer, Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Manufactureraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Contract manufactureraccessdata.fda.gov
Catheter, Intravascular, Plaque Morphology EvaluationOGZ2Contract manufactureraccessdata.fda.gov
Catheter, Ultrasound, IntravascularOBJ2Contract manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Contract manufactureraccessdata.fda.gov
Drape, Patient, OphthalmicHMT2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Contract manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Drape, Urological, DisposableEYY2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dress, SurgicalFYE1Repackager or relabeleraccessdata.fda.gov
General Surgery TrayLRO2Manufactureraccessdata.fda.gov
Gown, SurgicalFYA2Repackager or relabeleraccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Contract manufactureraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUContract manufactureraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Manufactureraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Contract manufactureraccessdata.fda.gov
Pack, Hot Or Cold, Water CirculatingILO2Contract manufactureraccessdata.fda.gov
Shield, Protective, PersonnelKPY1Manufactureraccessdata.fda.gov
Shunt, Central Nervous System And ComponentsJXG2Contract manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Contract manufactureraccessdata.fda.gov
Transducer, UltrasonicJOP2Repackager or relabeleraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Repackager or relabeleraccessdata.fda.gov
UrinalFNP1Manufactureraccessdata.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
May 18, 2022K220333Medline Orbis LVL 3 Surgical GownFYASubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
July 4, 2019K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)FYASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 24, 2019K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)FYASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
March 14, 1996K953673ECLIPSE PROBE COVERIYOSubstantially EquivalentParker Laboratories, Inc.accessdata.fda.gov
December 2, 1991K914077REPEL(TM) LITE CUT RESISTANT GLOVE LINERSLYUSubstantially EquivalentDepuy-Raynhamaccessdata.fda.gov
May 9, 1991K910941LIFELINER SURGICAL GLOVEFYESubstantially EquivalentDepuy-Raynhamaccessdata.fda.gov
March 1, 1990K900310REPEL SURGICAL GLOVE LINERSLYUSubstantially EquivalentDepuy-Raynhamaccessdata.fda.gov
August 23, 1984K843262TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASOJOPSubstantially EquivalentHewlett-Packard Co.accessdata.fda.gov
October 10, 1980K802146AQUASONIC 100 ULTRASOUND TRANS. GEL,IYOSubstantially EquivalentParker Laboratories, Inc.accessdata.fda.gov

Compare with other makers

Updated May 18, 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.