Data / Medical devices / United States / Cosmofrance

Cosmofrance: FDA-registered device maker in Miami, FL, United States, 5 510(k) clearances

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

Cosmofrance is registered with the FDA (registration 3007895168) in Miami, FL, United States. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 7, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007895168
Address: 2121 SW 3rd Avenue, Suite 500, Miami, FL, United States, 33129
Owner or operator: COSMOFRANCE (10032329)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: October 29, 2014
Registered through: 2026
Brand names listed: Cosmopen, DERMASCULPT, EZCONNECTOR, EZCOOL, EZGEL, EZHEAT, EZINJECT, EZPRF and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Connector, Catheter	GCD	1	Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Repackager or relabeler	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Complaint file establishment, 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 7, 2019	K191361	DemeDIOX Barbed Absorbable Surgical Suture	NEW	Substantially Equivalent	Demetech Corporation	accessdata.fda.gov
August 27, 2018	K181582	DemeTECH DemeDIOX absorbable surgical suture	NEW	Substantially Equivalent	Demetech Corporation	accessdata.fda.gov
November 22, 2016	K160761	DW-1C	NEW	Substantially Equivalent	Dongwon Medical Co., Ltd.	accessdata.fda.gov
December 14, 2011	K112057	KDL SYRINGES AND NEEDLE	FMF	Substantially Equivalent	Shanghai Kindly Enterprise Dev. Group Co.,	accessdata.fda.gov
June 10, 2011	K103736	DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE	FMF	Substantially Equivalent	Dmc Medical, Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 7, 2019. 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.