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Metier Medical (usa) LLC: FDA-registered device maker in Ponte Vedra Beach, FL, United States, 14 510(k) clearances

Name: Metier Medical (usa) LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Metier Medical (usa) LLC is registered with the FDA (registration 3010405396) in Ponte Vedra Beach, FL, United States. It lists 7 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 30, 2023. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3010405396
Address: 105 Solana Rd Ste B, Ponte Vedra Beach, FL, United States, 32082
Owner or operator: Metier Medical (USA) LLC (10044849)
Roles: Complaint file establishment
First device listed: December 8, 2020
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Needle, Aspiration And Injection, Disposable	GAA	1	Complaint file establishment	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Complaint file establishment	accessdata.fda.gov
Saline, Vascular Access Flush	NGT	2	Complaint file establishment	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Complaint file establishment	accessdata.fda.gov
Syringe, Antistick	MEG	2	Complaint file establishment	accessdata.fda.gov
Syringe, Piston	FMF	2	Complaint file establishment	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Complaint file establishment	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 30, 2023	K230061	Insulin Syringe	FMF	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
August 12, 2023	K230756	TK Pre-Filled Normal Saline Flush Syringe	NGT	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
November 4, 2022	K222124	Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle	FMI	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
November 4, 2021	K212019	Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single	JKA	Substantially Equivalent	Jiangsu Micsafe Medical Technology Co., Ltd.	accessdata.fda.gov
October 18, 2021	K211555	Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe	MEG	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
July 16, 2021	K210103	SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX	FMF	Substantially Equivalent	Lifelong Meditech Private Limited	accessdata.fda.gov
June 25, 2021	K211293	Safety Winged Blood Collection Sets	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
December 14, 2020	K201284	Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use	FMF	Substantially Equivalent	Set Medikal Sanayi VE Ticaret Anonim Sirketi	accessdata.fda.gov
September 11, 2020	K191639	TK Insulin Syringe with/without Saftey Retractable Device	MEG	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
January 6, 2020	K191642	TK Sterile Piston Syringe without Needle	FMF	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
December 19, 2019	K191643	TK Sterile Hypodermic Needle	FMI	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
September 6, 2019	K183665	Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use	MEG	Substantially Equivalent	Jiangsu Micsafe Medical Technology Co., Ltd.	accessdata.fda.gov
June 14, 2018	K172938	Disposable Sterile Needle	FMI	Substantially Equivalent	Jiangsu Caina Medical Co.,Ltd	accessdata.fda.gov
August 2, 2017	K170651	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle	MEG	Substantially Equivalent	Yangzhou Medline Industry, Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 30, 2023. 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.