MedtechSourcebook

PARKELL, INC.

Contract manufacturer ยท Edgewood, NY

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
2411797 (openFDA record; or search FDA's registration database)
FEI number
2411797
Registered for
FDA registration year 2026
Establishment types
Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
Parkell, Inc (FDA owner/operator no. 10047694)
Registered address
300 EXECUTIVE DR., Edgewood, NY 11717
Contract listings
1 device listings, 1 product codes, first listed Oct 18, 2016
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
ELCScaler, UltrasonicClass IIDentalContract manufacturingOct 18, 2016