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Sol-Millennium Medical, Inc.

United States·US-MF-000010890

Last updated September 17, 2026

What Sol-Millennium Medical, Inc. makes

Sol-Millennium Medical, Inc. manufactures single-use medical devices for fluid administration, blood collection, and insulin delivery, including general-purpose syringes, hypodermic needles with integrated safety guards, insulin syringes with fixed needles, and vascular catheter introduction sets. Their portfolio also covers blood collection sets with non-fixed needles and metered-delivery syringes designed for precise medication dosing. Needle guards and safety mechanisms are featured across multiple products to reduce sharps injuries during use.

The company’s devices are regulated under the US FDA’s Class I and Class II/IIa classifications, with some entries listed in the EU’s EUDAMED database. Authorisation records include FDA’s 510(k) premarket notifications and Unique Device Identifiers (UDIs). The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 311 S Wacker Drive, Suite 4100, Chicago, United States
Website: sol-m.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Yajaira Orozco
EUDAMED SRN: US-MF-000010890
FDA FEI Number: 3014312726
DUNS Number: —

Catalogue (489)

Page 2 of 10

Device	Model / Reference	Registries	Class	Status
SOL-M™ Multi-Sample Needle	110201020002	FDA UDI	Class II	Active
SOL-M™ Slip Tip Syringe w/o Needle	180005ST	FDA UDI	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	1653012	FDA UDI	Class II	Active
SOL-CARE Syringe with Safety Needle	12705SN	FDA UDI	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	110102010042	FDA UDI	Class II	Active
SOL-M Blunt Fill Needle 18G*1 1/2"	110022	FDA UDI	Class I	Active
SOL-M Hypodermic Needle 18G*1 1/2"(Bulk, Non-sterile)	111815B	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	32310SN	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	102015SN	FDA UDI	Class II	Active
SOL-CARE Syringe with Safety Needle	32310SN	FDA UDI	Class II	Active
SOL-CARE 5ml Luer Lock Syringe w/Safety Needle 21G*1/2	52115SN	FDA UDI	Class II	Active
SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2	32115SN	FDA UDI	Class II	Active
SOL-M™ Multi-Sample Needle	110201020006	FDA UDI	Class II	Active
SOL-CARE Syringe with Safety Needle	32510SN	FDA UDI	Class II	Active
SOL-GUARD™ TB Safety Syringe with Fixed Needle	2152215SG	FDA UDI	Class II	Active
SOL-CARE™ Safety Blood Collection Needle	110201030001	FDA UDI	Class II	Active
SOL-CARE Safety Needle	PSN2558	FDA UDI	Class II	Active
Holymed surgical gowns AAMI Level 4 XL	SIGA412	FDA UDI	Class I	Active
SOL-CARE Safety Needle	PSN2712	FDA UDI	Class II	Active
SOL-M™ Slip Tip Syringe w/o Needle	180020ST	FDA UDI	Class II	Active
SOL-CARE™ Safety Needle	SN2558	FDA UDI	Class II	Active
SOL-M 60ml Slip Tip Syringe w/o Needle	P180060ST	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	52215SN	FDA UDI	Class II	Active
SOL-M™ Syringe w/Fixed Needle (Low Dead Space)	110401010002	FDA UDI	Class II	Active
SOL-CARE Safety Needle	PSN2210	FDA UDI	Class II	Active
SOL-M™ Multi-Sample Needle	110201020008	FDA UDI	Class II	Active
GREER 1ml Allergenic Extract Mixing Syringe Tray 23G*1/2"	GROM-23-2	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	102215SN	FDA UDI	Class II	Active
SOL-M™ Luer Lock Syringe without Needle	180060	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	52015SN	FDA UDI	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	1652912	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	102115SN	FDA UDI	Class II	Active
SOL-M™ Slip Tip Syringe w/o Needle	180050ST	FDA UDI	Class II	Active
SOL-CARE Safety Needle 25G*1	SN2510	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	102010SN	FDA UDI	Class II	Active
SOL-M Insulin Syringe	1652712B	FDA UDI	Class II	Active
SOL-M™ Luer Lock Syringe without Needle	180010	FDA UDI	Class II	Active
SOL-M™ Multi-Sample Needle	110201020001	FDA UDI	Class II	Active
SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder	110201030010	FDA UDI	Class II	Active
SOL-CARE Safety Needle	PSN1815	FDA UDI	Class II	Active
SOL-CARE Safety Needle 18G*1 (LD)	SN1810	FDA UDI	Class II	Active
SOL-CARE™ Safety Blood Collection Needle	110201030007	FDA UDI	Class II	Active
SOL-CARE Syringe with Safety Needle	32215SN	FDA UDI	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	1612912B	FDA UDI	Class II	Active
SOL-M™ Luer Lock Syringe without Needle	180003	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	32510SN	FDA UDI	Class II	Active
SOL-M Insulin Syringe	1612712B	FDA UDI	Class II	Active
SOL-M Insulin Syringe	1612758B	FDA UDI	Class II	Active
SOL-M™ Multi-Sample Needle	110201020007	FDA UDI	Class II	Active
SOL-M Insulin Syringe	1652812B	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Sol-Millennium Europe Sp. z o.o. PL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Sol-Millennium Medical, Inc. has six recall records, all initiated on May 9, 2024. The records are marked as either open or classified, with the sole reason stated being that products in distribution were found by the FDA to differ substantially from the current cleared 510(k) submissions due to a major change or modification to the device’s intended use.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 9, 2024	Z-3077-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3079-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3075-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3074-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3076-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3078-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.