Medical Device Manufacturer · US , Lawrenceville , GA

Sol-Millennium Medical, Inc.

12 submissions · 12 cleared · Since 2014
12
Total
12
Cleared
0
Denied

Sol-Millennium Medical, Inc. — FDA 510(k) Submissions

Sol-Millennium Medical, Inc. has submitted 12 FDA 510(k) premarket notifications since 2014, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Syringe, Piston, Tubes, Vials, Systems, Serum Separators, Blood Collection, Syringe, Antistick, Needle, Hypodermic, Single Lumen, Low Dead Space Piston Syringe . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
K250907 · JKA Tubes, Vials, Systems,... · General Hospital
Apr 2025 35d
SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
K242291 · QNQ Low Dead Space Piston... · General Hospital
Nov 2024 110d
Sol-M? Slip Tip Syringe without Needle, Sol-M? Eccentric Tip Syringe without Needle
K242099 · FMF Syringe, Piston · General Hospital
Oct 2024 96d
Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle
K241821 · FMF Syringe, Piston · General Hospital
Sep 2024 88d
Sol-Guard Auto-disable Syringe
K220713 · FMF Syringe, Piston · General Hospital
May 2023 419d
Sol-M Luer Lock Syringe
K222744 · FMF Syringe, Piston · General Hospital
Oct 2022 29d
SOL-GUARD Safety Pull Button Collection Set
K213718 · JKA Tubes, Vials, Systems,... · General Hospital
Aug 2022 279d
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
K182146 · FMI Needle, Hypodermic,... · General Hospital
Dec 2018 117d
Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
K163073 · JKA Tubes, Vials, Systems,... · Chemistry
May 2017 198d
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
K162030 · MEG Syringe, Antistick · General Hospital
Aug 2016 28d
Sol-M Insulin Syringe, Sol-M TB Syringe
K153537 · FMF Syringe, Piston · General Hospital
Jun 2016 190d
SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
K132681 · MEG Syringe, Antistick · General Hospital
May 2014 267d
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