Data / Medical devices / United States / Sarasota Medical Products

Sarasota Medical Products: FDA-registered device maker in Sarasota, FL, United States, 1 510(k) clearance

Name: Sarasota Medical Products FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sarasota Medical Products is registered with the FDA (registration 3009167225) in Sarasota, FL, United States. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 27, 2015. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3009167225
Address: 1451 Sarasota Center Blvd, Sarasota, FL, United States, 34240
Owner or operator: Sarasota Medical Products (10041215)
Roles: Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler
First device listed: July 2, 2012
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Colostomy, Disposable	EZS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bag, Stomal	GDS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bag, Urinary, Ileostomy	EXH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bag, Urine Collecting, Ureterostomy	EXG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Collector, Ostomy	EXB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Contract manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Contract manufacturer, Manufacturer, Remanufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Contract manufacturer	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Contract manufacturer, Manufacturer, Repackager or relabeler	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
November 27, 2015	K151186	Stay Fresh Hydrocolloid dressing	FRO	Substantially Equivalent	Sarasota Medical Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated November 27, 2015. 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.