Baylis Medical Technologies, Inc. FDA Approvals

0 new drug approvals and 5 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
Baylis Connector Cable510(k)Jan 18, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jan 18, 2026
PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch510(k)Oct 28, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Oct 28, 2025
PowerWire® 14 Radiofrequency Guidewire Kit510(k)Sep 11, 2025Cardiovascular	Cardiovascular	510(k)Unknown (Traditional)	Sep 11, 2025
PowerWire Radiofrequency Guidewire Kit510(k)Feb 28, 2024Cardiovascular	Cardiovascular	510(k)Unknown (Traditional)	Feb 28, 2024
RFP-100A Connector Cable (Single Use)510(k)May 30, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 30, 2023