Medical Device Manufacturer · US , Mukwonago , WI

Unimed Medical Supplies, Inc.

18 submissions · 18 cleared · Since 2008
18
Total
18
Cleared
0
Denied

Unimed Medical Supplies, Inc. — FDA 510(k) Submissions

Unimed Medical Supplies, Inc. has submitted 18 FDA 510(k) premarket notifications since 2008, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Oximeter, Blood Pressure Cuff, Cable, Transducer And Electrode, Patient, (including Connector), Continuous Measurement Thermometer, Analyzer, Gas, Carbon-dioxide, Gaseous-phase . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
Disposable Neonatal NIBP Cuff (U1681S-C51N)
K253964 · DXQ Blood Pressure Cuff · Cardiovascular
Jan 2026 29d
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
K251691 · DQA Oximeter · Anesthesiology
Dec 2025 182d
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
K251696 · DQA Oximeter · Anesthesiology
Dec 2025 182d
Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)
K251693 · DQA Oximeter · Anesthesiology
Nov 2025 169d
Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)
K251695 · DQA Oximeter · Anesthesiology
Nov 2025 169d
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)
K250931 · DQA Oximeter · Anesthesiology
Aug 2025 138d
Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
K251045 · DXQ Blood Pressure Cuff · Cardiovascular
Jul 2025 103d
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
K243086 · DQA Oximeter · Anesthesiology
Feb 2025 143d
Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)
K242580 · DQA Oximeter · Anesthesiology
Feb 2025 160d
Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
K222213 · DQA Oximeter · Anesthesiology
Dec 2022 147d
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
K210019 · CCK Analyzer, Gas,... · Anesthesiology
Mar 2021 59d
Unimed Disposable and Reusable SPO2 Sensors
K142832 · DQA Oximeter · Anesthesiology
Feb 2015 129d
Unimed Disposable ECG lead wires
K142489 · DSA Cable, Transducer And... · Cardiovascular
Nov 2014 61d
UNIMED TEMPERATURE PROBE
K121427 · FLL Continuous Measurement... · General Hospital
May 2012 15d
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · DXQ Blood Pressure Cuff · Cardiovascular
May 2012 88d
UNIMED BLOOD PRESSURE CUFF
K112544 · DXQ Blood Pressure Cuff · Cardiovascular
Nov 2011 82d
REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)
K082546 · DQA Oximeter · Anesthesiology
Dec 2008 90d
PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
K082959 · DSA Cable, Transducer And... · Cardiovascular
Oct 2008 7d
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