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

Microtek Dominicana, S.A.S.: FDA-registered device maker in Las Americas Santo Domingo, Dominican Republic, 4 510(k) clearances

Name: Microtek Dominicana, S.A.S. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Microtek Dominicana, S.A.S. is registered with the FDA (registration 3012811961) in Las Americas Santo Domingo, Dominican Republic. It lists 11 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 18, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012811961
Address: Las Americas Industrial Free Zone Park Km 22 Autopista, Las Americas Santo Domingo, Dominican Republic, 11606
Owner or operator: Medline Industries, LP (1417592)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: August 10, 2010
Registered through: 2027
Brand names listed: AKTORmed, Aquablation Therapy, BEDDING, BSC MDU5 Bag, CleanOp: bedding and cleaning supplies, ComfortGlide Drypad, Convenience Trays & Kits CSTM, Convertors and more

Devices it lists

Device	Product code	Class	Role	Source
Bedding, Disposable, Medical	KME	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Contract manufacturer	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Contract manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ear, Nose, And Throat Surgical Tray	OGR	1	Contract manufacturer	accessdata.fda.gov
General Surgery Tray	LRO	2	Contract manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Surgical, Computer Controlled Instrument	NAY	2	Contract manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Contract manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 18, 2022	K220333	Medline Orbis LVL 3 Surgical Gown	FYA	Substantially Equivalent	Medline Industries, LP	accessdata.fda.gov
July 4, 2019	K190950	Medline 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)	FYA	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
April 24, 2019	K182172	Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)	FYA	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
October 10, 1980	K802146	AQUASONIC 100 ULTRASOUND TRANS. GEL,	IYO	Substantially Equivalent	Parker 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.