Data / Medical devices / United States / Demetech Corp.

Demetech Corp.: FDA-registered device maker in Miami Lakes, FL, United States, 16 510(k) clearances

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

Demetech Corp. is registered with the FDA (registration 1064584) in Miami Lakes, FL, United States. It lists 16 device types. The FDA files 16 510(k) clearances under its listings, the newest dated July 24, 2020. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1064584
FEI number: 3003063934
Address: 5980 Miami Lakes Drive, Miami Lakes, FL, United States, 33014
Owner or operator: DEMETECH CORP. (9041973)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: May 7, 2002
Registered through: 2027
Brand names listed: DemeBOND, DemeCAPRONE, DemeCRYL, DemeDIOX, DemeDIOX Barbed, DemeDIOX Barbed with Novathreads-Absorbable Polydioxane Surgical Suture, DemeDIOX with Novathreads-Absorbable Polydioxane Surgical Suture, DemeFORCE UHMWPE and more

Devices it lists

Device	Product code	Class	Role	Source
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Contract manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Manufacturer	accessdata.fda.gov
Respirator, Surgical	MSH	2	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Natural	GAL	2	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Manufacturer	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Manufacturer	accessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	NBY	2	Manufacturer	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	NNZ	1	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
July 24, 2020	K201479	DemeMASK	FXX	Substantially Equivalent	Demetech Corporation	accessdata.fda.gov
November 7, 2019	K191361	DemeDIOX Barbed Absorbable Surgical Suture	NEW	Substantially Equivalent	Demetech Corporation	accessdata.fda.gov
July 31, 2019	K190777	DemeTECH DemeFORCE Nonabsorbable Surgical Suture	GAT	Substantially Equivalent	Demetech Corporation	accessdata.fda.gov
October 11, 2018	K181578	DemeTECH PTFE Nonabsorbable Surgical Suture	NBY	Substantially Equivalent	Demetech Corporation	accessdata.fda.gov
August 27, 2018	K181582	DemeTECH DemeDIOX absorbable surgical suture	NEW	Substantially Equivalent	Demetech Corporation	accessdata.fda.gov
September 25, 2014	K141007	DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE	GAQ	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
May 30, 2014	K123940	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	GAM	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
July 17, 2013	K130083	DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE	GAM	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
January 8, 2010	K082097	DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE	NEW	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
April 30, 2008	K072930	DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT	GAL	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
July 26, 2006	K060018	TRULENE MESH	FTL	Substantially Equivalent	Sutures India Pvt., Ltd.	accessdata.fda.gov
May 16, 2005	K043330	POLYPROPILENE SURGICAL SUTURES	GAW	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
April 6, 2005	K043539	DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES	GAM	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
June 18, 2003	K023030	DEMETECH POLYESTER NONABSORBABLE SUTURE	GAT	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
June 18, 2003	K023028	DEMETECH NYLON NONABSORBABLE SUTURE	GAR	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
November 25, 2002	K023029	DEMETECH SILK NONABSORBABLE SUTURE	GAP	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov

Compare with other makers

Updated July 24, 2020. 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.