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Unimed Medical Supplies, Inc. FDA Approvals

0 new drug approvals and 13 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)510(k)Jun 5, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jun 5, 2026
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)510(k)Apr 14, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 14, 2026
Disposable Neonatal NIBP Cuff (U1681S-C51N)510(k)Jan 9, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jan 9, 2026
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)510(k)Dec 1, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 1, 2025
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)510(k)Dec 1, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 1, 2025
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)510(k)Nov 18, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 18, 2025
Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)510(k)Nov 18, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 18, 2025
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)510(k)Aug 13, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 13, 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)510(k)Jul 15, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 15, 2025
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)510(k)Feb 20, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 20, 2025
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)510(k)Feb 6, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 6, 2025
Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)510(k)Dec 19, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 19, 2022
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+510(k)Mar 4, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Mar 4, 2021

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