FDA.reportPublic FDA data

MENDAERA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30318518753031851875MENDAERA, INC.1N2026-01-01700 S Claremont St Ste 200 San Mateo CA US 94402

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850062065024Mendaera Universal Instrument Guide Kit, Long - K001-011-877-636-3237support@mendaera.com
00850062065048Mendaera Universal Instrument Guide Kit, Short - K002-011-877-636-3237support@mendaera.com
00850062065055Focalist Universal Short Instrument Guide Kit - K002-011-877-636-3237support@mendaera.com
00850062065062Mendaera Robot Drape Kit - K003-011-877-636-3237support@mendaera.com
00850062065079Focalist Universal Long Instrument Guide Kit - K001-011-877-636-3237support@mendaera.com
00850062065093Focalist Robot Drape Kit - K003-011-877-636-3237support@mendaera.com
00850062065109Focalist Probe and Robot Drape Kit - K004-011-877-636-3237support@mendaera.com
00850062065116Focalist System Software - 11-877-636-3237support@mendaera.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3416811276903747K250524Mendaera Guidance SystemITX2025-07-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ITX12025-07-02

PMN#

GUDID#