International Biomedical FDA Approvals

0 new drug approvals and 3 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
Infant Heel WarmerTM; Heel Snuggler®510(k)Oct 7, 2022Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Oct 7, 2022
InfaTherm Disposable Infant Warming Mattress510(k)Oct 6, 2022Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Oct 6, 2022
NxtGen Infant Transport Incubator510(k)Jul 15, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 15, 2022