Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010405396

FEI Number

3010405396

Entity Name

METIER MEDICAL (USA) LLC

City/State/Country

Ponte Vedra Beach, FL, US

Establishment Address

105 Solana Rd Ste B, Ponte Vedra Beach, FL 32082, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Metier Medical (USA) LLC (Owner Number: 10044849)

Owner / Operator Contact Address

Suite B - 105 Solana Road, Ponte Vedra Beach, FL 32082, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191643

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2024-12-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-12-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-04-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-12-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-06-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-06-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-06-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-04-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-04-11
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2022-04-11
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2023-12-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-09-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Metier Medical (USA) LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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3015528193	Almac Pharma Services (Ireland) Limited	Dundalk Louth, IE
3008719222	ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010405396. Last updated year: 2026. Please use registration number 3010405396 when referencing this establishment in official correspondence.